| Primary | Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1 | ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) which included all dosed participants with measurable disease at baseline per RECIST v1.1 and who had at least one evaluable post-baseline tumor assessment unless treatment was discontinued due to clinical disease progression or death before the first post-treatment tumor assessment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Binomial exact test | | 0.0002 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification | A TEAE was defined as adverse event (AE) that had an onset date or a worsening in severity from baseline (pre-treatment) on or after the first dose of study drug(s) and up to 30 days following study drug(s) discontinuation or initiation of new anticancer therapy, whichever occurs first determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. SAE: any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator. | Analysis was performed on safety analysis set which included all participants who received at least 1 dose of any study drug (any component for the combination therapy). | Posted | | Count of Participants | | Participants | | From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1 | ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. Per modified RECIST (mRECIST), CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST) | ORR was defined as the percentage of participants achieving the BOR of immune complete response (iCR) or partial response (iPR). The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by The Investigator Based on RECIST v1.1 | DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurred earlier). DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1 | DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurred earlier). DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST | DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. PD: an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST | DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. PD: an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST | DOR was defined as the time interval between the date of the earliest qualifying response (iCR or iPR) and the date of confirmed progressive disease (iCPD) or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST | DOR was defined as the time interval between the date of the earliest qualifying response (iCR or iPR) and the date of confirmed progressive disease (iCPD) or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response. | Posted | | Median | 95% Confidence Interval | months | | From the date of earliest response to the date of first documentation of disease progression or death, whichever occurs first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1 | DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST | DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable disease (SD): any cases that do not qualify for either partial response or progressive disease. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST | DCR was defined as the percentage of participants with BOR of iCR, iPR or immune stable disease (iSD). Participants without post-baseline tumor assessment were considered a failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Number | 95% Confidence Interval | percentage of participants | | Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1 | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
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| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1 | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per mRECIST, PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per mRECIST, PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (iCPD) or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per iRECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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| Secondary | Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST | PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (iCPD) or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per iRECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression. | Analysis was performed on Efficacy-Evaluable Analysis Set (EFF). | Posted | | Median | 95% Confidence Interval | months | | From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months) | | | | ID | Title | Description |
|---|
| OG000 | Lenvatinib With Tislelizumab | Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of >= 60 kg or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
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