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At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States.
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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2).
The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period |
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| Part 2 | Experimental | Patients will be enrolled to one of the following expansion cohorts:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | Oral VEGFR inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs) | According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting >7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for <72 hours with antiemetic and supportive care, G 3 fatigue for <1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment. | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks) |
| Part 1: Recommended Phase 2 Dose (RP2D) of Fruquintinib in Combination With Tislelizumab | The RP2D of fruquintinib in combination with tislelizumab based on the safety and tolerability assessments in Part 1 patients. | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks) |
| Part 2: Objective Response Rate (ORR) | The ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective Response Rate | The ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| William Schelman, MD, PhD | HUTCHMED International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Highlands Oncology |
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The study consisted of a safety lead-in phase (Part 1) and a dose expansion phase (Part 2). A total of 52 patients were enrolled in this study (6 patients received study treatment in Part 1 and 46 patients received study treatment in Part 2). The study was terminated early based upon the strategic evaluation of clinical development of fruquintinib in the United States. This change was not based on any concern for patient safety or efficacy relative to fruquintinib and/or tislelizumab treatment.
This phase 1b/2, 2-part, open-label study was conducted in patients with advanced or metastatic solid tumors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting) | Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either immuno-oncology (IO)-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 milligrams (mg) orally once daily (QD) for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg intravenous (IV) infusion once every 4 weeks (Q4W) until radiologically determined progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, unacceptable toxicity, death, or withdrawal from study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2023 | May 12, 2025 |
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| Tislelizumab | Drug | PD-1 inhibitor |
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| Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Parts 1 and 2: Progression-free Survival (PFS) | PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. The 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 (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Parts 1 and 2: Disease Control Rate (DCR) | The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Parts 1 and 2: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD (i.e., lasting for at least 6 months) as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Parts 1 and 2: Duration of Response (DoR) | The DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, whichever came first until PD or death. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The 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 (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
| Parts 1 and 2: Overall Survival (OS) | The OS was defined as the time from start of study treatment until the date of death due to any cause. | From the first dose of study treatment (Day 1) up to date of death due to any cause, up to a maximum of approximately 34 months |
| Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11 | Blood samples were collected at the specified timepoints to determine plasma concentrations of fruquintinib and metabolite M11. | Pre-dose on Days 1, 8, 15, 21 of Cycle 1 and on Day 1 of Cycles 2, 4, 7, 13; 2 to 4 hours post-dose on Days 1 and 21 of Cycle 1 (cycle duration: 4 weeks) |
| Parts 1 and 2: Serum Concentrations of Tislelizumab | Blood samples were collected at the specified timepoints to determine serum concentrations of tislelizumab. | Pre-infusion on Day 1 of Cycles 1, 2, 4, 7, 13; at end of infusion on Day 1 of Cycles 1 and 4; on Days 8, 15, and 21 of Cycle 1 (cycle duration: 4 weeks) |
| Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab | Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. | From the first dose of study treatment (Day 1) up to end of treatment, up to approximately 17 months for Part 1 and 20 months for Part 2 |
| Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation | An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was an abnormal pregnancy outcome in a child born to a female patient/female partner of a male patient exposed to study treatment or was an important medical event. TEAEs were AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration. | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 21 months |
| Part 2: Change From Baseline in Programmed Death-Ligand 1 (PD-L1) Expression | Expression of PD-L1 biomarker was planned to be assessed in tumor tissues of the patients. Baseline was defined as the last non-missing assessment prior to the first administration of any study treatment (whichever occurred first), including scheduled and unscheduled visits, unless otherwise specified. | Baseline (Day 1) up to end of treatment, up to approximately 20 months |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Florida Cancer Specialists - FCS South | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Center North | St. Petersburg | Florida | 33709 | United States |
| Florida Cancer Specialists Panhandle | Tallahassee | Florida | 32308 | United States |
| Florida Cancer Specialists - East (FCS East) | West Palm Beach | Florida | 33401 | United States |
| HOC AON Baton Rouge / Sarah Cannon | Baton Rouge | Louisiana | 70809 | United States |
| Messino Cancer Center | Asheville | North Carolina | 28806 | United States |
| Oklahoma University Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| Tennessee Oncology-Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennesse Oncology | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG001 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic triple negative breast cancer (TNBC) including those with estrogen receptor (ER) or progesterone receptor (PGR) low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| FG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an immune checkpoint inhibitor (ICI) or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| FG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic endometrial cancer (EC) who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| FG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic (m) microsatellite stable (MSS) colorectal cancer (CRC) who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-vascular endothelial growth factor (VEGF) (if rat sarcoma [RAS]: wild-type tumor, mutated or status unknown) or endothelial growth factor receptor (EGFR) (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| COMPLETED | All patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type [1 patient was included in Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) and 5 patients were included in Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting).](streamdown:incomplete-link) |
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| NOT COMPLETED |
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| Part 2 |
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The safety analysis set (SAS) included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. 1 patient enrolled in Part 1 was also included in Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) and 5 patients enrolled in Part 1 were also included in Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| BG001 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| BG002 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| BG003 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs) | According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting >7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for <72 hours with antiemetic and supportive care, G 3 fatigue for <1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment. | The DLT-evaluable analysis set included all patients enrolled in Part 1 of the study who received at least 1 dose of fruquintinib or tislelizumab and were considered DLT-evaluable based on the safety review committee review, according to the pre-specified criteria from the protocol. | Posted | Count of Participants | Participants | No | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks) |
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| Primary | Part 1: Recommended Phase 2 Dose (RP2D) of Fruquintinib in Combination With Tislelizumab | The RP2D of fruquintinib in combination with tislelizumab based on the safety and tolerability assessments in Part 1 patients. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Number | mg | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks) |
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| Primary | Part 2: Objective Response Rate (ORR) | The ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Number | 95% Confidence Interval | percentage of patients | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Part 1: Objective Response Rate | The ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Number | 95% Confidence Interval | percentage of patients | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Progression-free Survival (PFS) | PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. The 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 (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Disease Control Rate (DCR) | The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Number | 95% Confidence Interval | percentage of patients | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD (i.e., lasting for at least 6 months) as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Number | 95% Confidence Interval | percentage of patients | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Duration of Response (DoR) | The DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, whichever came first until PD or death. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The 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 (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Only those patients with PR or CR (responders) were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Overall Survival (OS) | The OS was defined as the time from start of study treatment until the date of death due to any cause. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Median | 95% Confidence Interval | months | From the first dose of study treatment (Day 1) up to date of death due to any cause, up to a maximum of approximately 34 months |
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| Secondary | Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11 | Blood samples were collected at the specified timepoints to determine plasma concentrations of fruquintinib and metabolite M11. | The pharmacokinetic (PK) analysis set included all patients with at least 1 quantifiable plasma or serum concentration of fruquintinib and/or tislelizumab. Only unique patients in Parts 1 and 2 were considered for PK analysis. Cohort A did not enroll any unique patients in Part 2. Only patients who had a quantifiable plasma/serum concentration of fruquintinib at specified timepoints are reported. | Posted | Mean | Standard Deviation | nanograms per milliliter | Pre-dose on Days 1, 8, 15, 21 of Cycle 1 and on Day 1 of Cycles 2, 4, 7, 13; 2 to 4 hours post-dose on Days 1 and 21 of Cycle 1 (cycle duration: 4 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Parts 1 and 2: Serum Concentrations of Tislelizumab | Blood samples were collected at the specified timepoints to determine serum concentrations of tislelizumab. | The PK analysis set included all patients with at least 1 quantifiable plasma or serum concentration of fruquintinib and/or tislelizumab. Only unique patients in Parts 1 and 2 were considered for PK analysis. Cohort A did not enroll any unique patients in Part 2. Only patients who had a quantifiable plasma/serum concentration of tislelizumab at specified timepoints are reported. | Posted | Mean | Standard Deviation | micrograms per milliliter | Pre-infusion on Day 1 of Cycles 1, 2, 4, 7, 13; at end of infusion on Day 1 of Cycles 1 and 4; on Days 8, 15, and 21 of Cycle 1 (cycle duration: 4 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab | Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. | The ADA analysis set included all patients who received at least 1 dose of tislelizumab and had a baseline and at least 1 post-baseline ADA result. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Count of Participants | Participants | No | From the first dose of study treatment (Day 1) up to end of treatment, up to approximately 17 months for Part 1 and 20 months for Part 2 |
| |||||||||||||||||||||||||||
| Secondary | Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation | An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was an abnormal pregnancy outcome in a child born to a female patient/female partner of a male patient exposed to study treatment or was an important medical event. TEAEs were AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. | Posted | Count of Participants | Participants | No | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 21 months |
| |||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Programmed Death-Ligand 1 (PD-L1) Expression | Expression of PD-L1 biomarker was planned to be assessed in tumor tissues of the patients. Baseline was defined as the last non-missing assessment prior to the first administration of any study treatment (whichever occurred first), including scheduled and unscheduled visits, unless otherwise specified. | The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. Based upon the strategic evaluation of clinical development of fruquintinib in the United States, the study was early terminated prior to data collection for this outcome measure. | Posted | Baseline (Day 1) up to end of treatment, up to approximately 20 months |
|
Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. | 8 | 11 | 2 | 11 | 11 | 11 |
| EG002 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. | 20 | 39 | 20 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Protein total increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Thyroxine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Tri-iodothyronine free increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
The study was terminated early based upon the strategic evaluation of clinical development of fruquintinib in the United States. This change was not based on any concern for patient safety or efficacy relative to fruquintinib and/or tislelizumab treatment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Schelman, MD, PhD, Senior Vice President, Clinical Development, US/Europe | HUTCHMED International, Inc. | +1 9733064490 | williams@hutch-med.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2024 | May 12, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Progressive disease |
|
| Investigator decision |
|
| Sponsor terminated study |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| OG001 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
|
|
|
|
| OG001 |
| Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) |
Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
|
|
| OG001 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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| OG001 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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| OG001 | Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting) | Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG004 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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| OG001 | Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting) | Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG002 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
| OG002 | Part 2: Cohort C: EC (IO-Naïve) | Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
| OG003 | Part 2: Cohort D: MSS mCRC (IO-Naïve) | Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study. |
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