| Primary | Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT) | DLT=AEs in DLT observation period (OP) related to any study intervention:Grade (G)4 neutropenia;thrombocytopenia or anemia;febrile neutropenia;neutropenic infection;G3 thrombocytopenia with bleeding. Any G>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by medical therapy (MT), G3 diarrhea that improved to G<=2 within 72 hrs, G3 skin toxicity that resolved to G<=1 in <7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 lab abnormality [LA](medical intervention or hospitalization), or any G4 LA;ALT/AST>3*ULN (normal at baseline) or >3*ULN and doubling baseline (>ULN at baseline) and associated with total bilirubin(TB) >2*ULN;or ALT/AST>5*ULN; or TB>3*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator. | DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and either experienced DLT during the DLT-observation period or completed the DLT-observation period without DLT. | Posted | | Number | | Percentage of participants | | Day 1 up to Day 28 of Cycle 1 | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Primary | Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR) | Durable ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Primary | Phase 1b of Sub-Study B: Percentage of Participants With DLT | DLT=AEs in DLT OP related to any study intervention: G4 neutropenia; thrombocytopenia or anemia; neutropenia; neutropenic infection; G3 thrombocytopenia with bleeding. Any G>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by MT, G3 diarrhea that improved to G<=2 within 72 hrs, G3 skin toxicity that resolved to G<=1 in <7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 LA (medical intervention or hospitalization), or any G4 LA;ALT/AST>3*ULN (normal at baseline) or >3*ULN and doubling baseline (>ULN at baseline) and associated with TB >2*ULN; or ALT/AST>5*ULN; or TB>3*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator. | DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and either experienced DLT during the DLT-observation period or completed the DLT-observation period without DLT. | Posted | | Number | | Percentage of participants | | Day 1 up to Day 21 of Cycle 1 | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | |
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| Primary | Phase 2 Sub-Study B: Objective Response Rate | ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Median | 95% Confidence Interval | Percentage of participants | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 |
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| Secondary | Phase 1b of Sub-Study A: Number of Participants With Adverse Events (AEs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs was graded by the investigator according to NCI CTCAE grade 1 to 5 version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death. | Safety analysis set includes all participants who receive at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were planned to be graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Number of Participants With Shift From Baseline in Hematology Parameters Values Based on CTCAE V5.0 | Hematology parameters included: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, leukocytosis, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) |
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| Secondary | Phase 1b of Sub-Study A: Number of Participants With Shift From Baseline in Chemistry Parameters Values Based on CTCAE V5.0 | Chemistry parameters included: alanine aminotransferase (ALT) increase, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine phosphokinase (CPK) increased, chronic kidney disease (CKD), creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Chemistry abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Number of Participants With Laboratory Abnormalities | Hematology and clinical chemistry parameters were planned to be assessed. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Durable Objective Response Rate (ORR) | Durable ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 milli meter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level (if being followed) above the normal limits. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 38.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 1b of Sub-Study A: Objective Response Rate | Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. Non-CR/Non-PD: Persistence of any non-target lesions and/or tumor marker level (if being followed) above the normal limits. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 38.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 |
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| Secondary | Phase 2 of Sub-Study A: Objective Response Rate | Objective response (OR) rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Duration of Response (DR) | DR was defined for participants with confirmed OR as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first documentation of OR to the date of the first documentation of PD or death due to any cause, whichever occurred first | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Time to Tumor Response (TTR) | TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first dose of study treatment to the date of first documentation of objective response | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab, encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Progression-Free Survival (PFS) | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Overall Survival (OS) | OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first dose of study treatment to the date of death due to any cause or censoring date | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab | AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose. | Pharmacokinetic (PK) parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms*hour per milliliter | | Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Cycle 1 (pre-dose on Day 1, 168 hours [Day 8],336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Median | Full Range | Hour | | Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | | Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Ctrough of Encorafenib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. For 'Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg)' arm, samples were not analyzed for Cycle 2 Day 1 as it was collected incorrectly due to time deviation for visits. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1 (pre-dose) of Cycle 1, 2 and 5; Day 15 of Cycle 1 (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Ctrough of Encorafenib | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 5 Day 1 (pre-dose) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Ctrough of Binimetinib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Overall Number Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1 (pre-dose) of Cycles 1, 2, and 5 (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. |
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| Secondary | Phase 2 of Sub-Study A: Ctrough of Binimetinib | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Cycle 5 Day 1 (pre-dose) | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab | In this outcome measure, number of ADA-positive and NAb-positive participants has been presented. A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted). | Immunogenicity analysis set was a subset of the safety analysis set (participants who received at least 1 dose of study drug) and included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. All participants included in 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluated for ADA and NAb respectively. | Posted | | Count of Participants | | Participants | | Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days) (1 cycle= 28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) | Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 300 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle. | | OG001 |
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| Secondary | Phase 2 of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab | | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | Pre-dose on Cycle 1 Day 1 until end of treatment | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Objective Response (OR) Rate by Programmed Death Ligand-1 (PD-L1) Expression at Baseline | OR rate is defined as percentage of participants with CR or PR according to RECIST v1.1 based on investigator assessment. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. OR by PD-L1 expression at baseline was planned to be assessed. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected. | Posted | | | | | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Score | EORTC QLQ-C30: consisted of 30 questions grouped into 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and financial impact. All scales and single item measures ranged in score from 0 to 100. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the symptom scales and single items represent a greater presence of symptoms or financial impact. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and there was no data collection for it. | Posted | | | | | | Baseline up to end of treatment | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab, encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 2 of Sub-Study A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score | The EORTC QLQ-LC13 is the lung cancer specific module of the EORTC Quality of Life Questionnaire. The EORTC QLQ-LC13 consisted of 13 questions which included 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The item scale ranged from 1 to 4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm was applied to convert to a 0 to 100 point scale where 100 is best quality of life (QOL), for comparability. Higher scores are reflective of a greater presence of symptoms. | Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and there was no data collection for it. | Posted | | | | | | Baseline up to end of treatment | | | | ID | Title | Description |
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| OG000 | Phase 2: Sasanlimab + Encorafenib + Binimetinib | Participants with NSCLC with BRAFV600 mutations were planned to receive a combination of sasanlimab encorafenib and binimetinib at the recommended Phase 2 dose. |
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| Secondary | Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameters Values Based on CTCAE V5.0 | Hematology parameters included: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 39.3 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) |
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| Secondary | Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameters Values Based on CTCAE V5.0 | Chemistry parameters included: alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine phosphokinase (CPK) increased, chronic kidney disease (CKD), creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Chemistry abnormalities were graded as per NCI- CTCAE v 5.0 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe and G4= life-threatening or disabling. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. Number of participants with shift from baseline in hematology parameters by grades (as per CTCAE version 5.0) were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 | Hematology parameters included: anemia, hemoglobin increased, lymphocyte count decreased, leukocytosis, neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with shift from baseline in hematology parameters by grades as per CTCAE version 5.0 were reported. Grade 0= non-missing lab value that does not meet either of Grade 1 through 4 criteria; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | |
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| Secondary | Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 | Chemistry parameters included: ALT increased, ALP increased, AST increased, blood bilirubin increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Number of participants with maximum CTCAE V5.0 grade in chemistry parameters were reported. Grade 0= non-missing lab value that does not meet either of Grade 1 through 4 criteria; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | | Count of Participants | | Participants | | From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum exposure = 38.66 months; maximum follow-up approximately 39.66 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 |
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| Secondary | Phase 1b of Sub-Study B: Objective Response Rate | ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Two sided 95% CI was based on Clopper-Pearson method. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) |
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| Secondary | Phase 1b of Sub-Study B: Duration of Response (DR) | DR was defined for participants with confirmed objective response (OR) as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Data was not estimable due to insufficient number of participants (with events) evaluable for this outcome measure. | Posted | | | | | | From the date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) |
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| Secondary | Phase 1b of Sub-Study B: Time to Tumor Response (TTR) | TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | Data was not estimable due to insufficient number of participants (with events) evaluable for this outcome measure. | Posted | | | | | | From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Progression-Free Survival (PFS) | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Median | 95% Confidence Interval | Months | | From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Duration of Response (DR) | DR was defined for participants with confirmed OR as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no <4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Full analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and included only those participants with confirmed OR.' | Posted | | Median | 95% Confidence Interval | Months | | From date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Time to Tumor Response (TTR) | TTR is defined for participants with confirmed OR as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | Full analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | |
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| Secondary | Phase 2 of Sub-Study B: Progression-Free Survival (PFS) | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Median | 95% Confidence Interval | Months | | From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Overall Survival (OS) | OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Median | 95% Confidence Interval | Months | | From the date of first dose of study treatment to the date of death due to any cause or censoring date, whichever occurred first (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Cmax of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Cmax of Axitinib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, ''Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed date to the table. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Cmax of SEA-TGT | | PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. ''Number of Participants Analyzed'': participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable at specified timepoints. Data for only those participants who received SEA-TGT were planned to be reported for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Cmax of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Cmax of Axitinib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Cmax of SEA-TGT | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose on Cycle 1 Day 1 and Cycle 5 Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT | | PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters measured. 'Number of Participants Analyzed': participants evaluable for this outcome measure, 'Number Analyzed': participants evaluable at specified timepoints. Data for only those participants who received SEA-TGT were planned to be reported hence Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) arm was not reported. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab | | PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. 'Number of Participants Analyzed': participants with evaluable data for this outcome measure and 'Number Analyzed': participants evaluable at specified time points. This outcome measure was not applicable for participants of ''Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%'' | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Cycle 1: pre-dose on Day 1, Cycle 5: pre-dose on Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib | | PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT | | PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here 'Number of Participants Analyzed': participants evaluable for this outcome measure and 'Number Analyzed': participants evaluable at specified time points. This outcome measure was not applicable for participants of ''Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%'' | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT | A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= [4-fold dilution increase] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in >= 1 post-treatment sample (treatment-boosted). | Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. Here ''Number analyzed'' signifies number of participants with at least one post-treatment ADA result for respective category. | Posted | | Count of Participants | | Participants | | Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) | Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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| Secondary | Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT | | Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. | Posted | | Count of Participants | | Participants | | Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. | | OG001 | Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS >=50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle. | | OG002 | Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) |
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| Secondary | Phase 2 of Sub-Study B: Objective Response Rate by PD-L1 Expression in Available Tumor Tissue | ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10 millimeter [mm]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. | Full analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months) | | | | ID | Title | Description |
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| OG000 | Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Sasanlimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) | Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low PD-L1 levels TPS-49 % were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle. |
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