Advanced Solid Tumors
Conditions
Keywords
Solid tumors
Brief summary
This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC), or colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). The study was conducted in 2 parts. Part 1 was the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 assessed the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.
Detailed description
This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic, unresectable GC, and CRC or NSCLC. The study was conducted in 2 parts. Part 1 of the study was the safety run-in stage which assessed dose-limiting toxicities (DLTs) and RP2D. Part 2 began at RP2D. Participants enrolled in Part 1 at RP2D were counted towards Part 2; up to approximately 30 patients per cohort were enrolled at RP2D. The primary outcome measure of the study was ORR as assessed by the investigator as per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Tislelizumab and fruquintinib were administered until disease progression, intolerable toxicity, death, withdrawal of consent or until the study terminates.
Interventions
DRUGTislelizumab
Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.
DRUGFruquintinib
Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)
Sponsors
Hutchison Medipharma Limited
BeiGene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Signed informed consent form (ICF) and able to comply with study requirements. 2. At least 1 measurable lesion as defined by RECIST v1.1 3. Tumor tissue (archival tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment 4. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1 5. Histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction or colon or rectum, and histologically or cytologically confirmed, locally advanced (Stage IIIB) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) NSCLC Key
Exclusion criteria
1. Had at screening any central nervous system metastasis and/or leptomeningeal disease 2. Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways 3. Prior treatment with VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab) 4. Received more than 1 line of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction, or more than 2 lines of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of the colon or rectum, or prior systemic therapy for advanced or metastatic NSCLC 5. Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 Days | A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). |
| Part 1: Recommended Phase 2 Dose (RP2D) | Up to 28 Days | RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants. |
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months) | ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). 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 less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1 | From the first objective response to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years and 9 months) | DOR was defined as the time from the first occurrence of documented objective response to the time of progression as assessed by investigator per RECIST v1.1 or death from any cause, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method. |
| Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1 | From date of first dose of study drug until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months) | 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 (PD) or death, whichever occurs first. Median 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | From the date of the first dose of study drug up to 30 days after the last dose of study drug; up to approximately 2 years and 5 months. | A TEAE was defined as an 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 occurred first determined according to NCI-CTCAE v5.0. Treatment emergent serious Adverse Events (TESAEs): 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. AEs were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study. |
| Overall Survival (OS) | From the first dose of the study treatment to date of death from any cause (up to 2 years and 9 months) | OS was defined as the time from the date of first dose to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. |
| Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1 | From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months) | DCR was defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by investigator as per RECIST v1.1. 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. 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. |
| Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1 | From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months) | CBR was defined as the percentage of participants whose best overall response is CR, PR, or durable stable disease (SD) as assessed by the investigator per RECIST v1.1. 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. 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. |
Countries
China, South Korea
Participant flow
Pre-assignment details
The study consisted of 2 parts: Part 1 (Safety run-in) and Part 2 (Extension). Part 1 of the study with limited participants assessed dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D). These participants later moved to Part 2 of the study. Participant flow, baseline demographics and adverse event data were planned to be reported and analyzed for the combined Part 1 and Part 2 of study. All participants received same dose of study drugs (tislelizumab and fruquintinib).
Participants by arm
| Arm | Count |
|---|---|
| Gastric Cancer (GC): Tislelizumab and Fruquintinib Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. | 31 |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. | 31 |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. | 22 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Closed by Sponsor | 4 | 4 | 5 |
| Overall Study | Death | 24 | 24 | 8 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Gastric Cancer (GC): Tislelizumab and Fruquintinib | Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Total |
|---|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 8.71 | 58.8 years STANDARD_DEVIATION 7.88 | 63.5 years STANDARD_DEVIATION 11.28 | 60.1 years STANDARD_DEVIATION 9.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 31 Participants | 22 Participants | 83 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 17 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 24 / 31 | 24 / 31 | 8 / 22 |
| other Total, other adverse events | 28 / 31 | 29 / 31 | 19 / 22 |
| serious Total, serious adverse events | 13 / 31 | 14 / 31 | 13 / 22 |
Outcome results
Primary
Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). 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 less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)
Population: Analysis was performed on the safety analysis set which included all participants who received at least 1 dose of study drug(s).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab and Fruquintinib | Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | 12.9 percentage of participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | 9.7 percentage of participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | 40.9 percentage of participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
Time frame: Up to 28 Days
Population: Analysis was performed on the DLT evaluable analysis set that included all participants in Part 1 who received at least 85% of the assigned total dose of fruquintinib and at least 67% of the assigned total dose of tislelizumab during the DLT assessment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tislelizumab and Fruquintinib | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Part 1: Recommended Phase 2 Dose (RP2D)
RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.
Time frame: Up to 28 Days
Population: Analysis was performed on the DLT evaluable analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab and Fruquintinib | Part 1: Recommended Phase 2 Dose (RP2D) | 5.0 milligrams (mg) per day |
Secondary
Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1
CBR was defined as the percentage of participants whose best overall response is CR, PR, or durable stable disease (SD) as assessed by the investigator per RECIST v1.1. 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. 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.
Time frame: From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab and Fruquintinib | Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1 | 32.3 percentage of participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1 | 38.7 percentage of participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1 | 59.1 percentage of participants |
Secondary
Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1
DCR was defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by investigator as per RECIST v1.1. 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. 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.
Time frame: From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tislelizumab and Fruquintinib | Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1 | 74.2 percentage of participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1 | 74.2 percentage of participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1 | 68.2 percentage of participants |
Secondary
Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1
DOR was defined as the time from the first occurrence of documented objective response to the time of progression as assessed by investigator per RECIST v1.1 or death from any cause, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.
Time frame: From the first objective response to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years and 9 months)
Population: Analysis was performed using participants in the safety analysis set with an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab and Fruquintinib | Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1 | NA months |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1 | 11.9 months |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1 | NA months |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib
A TEAE was defined as an 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 occurred first determined according to NCI-CTCAE v5.0. Treatment emergent serious Adverse Events (TESAEs): 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. AEs were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.
Time frame: From the date of the first dose of study drug up to 30 days after the last dose of study drug; up to approximately 2 years and 5 months.
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs | 30 Participants |
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TESAEs | 13 Participants |
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | Grade 3 or Higher TEAEs | 18 Participants |
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Leading to Death | 3 Participants |
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Tislelizumab | 20 Participants |
| Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Fruquintinib | 25 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Fruquintinib | 26 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs | 31 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Leading to Death | 0 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Tislelizumab | 22 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TESAEs | 14 Participants |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | Grade 3 or Higher TEAEs | 21 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TESAEs | 13 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | Grade 3 or Higher TEAEs | 18 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Fruquintinib | 19 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Leading to Death | 1 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs | 22 Participants |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib | TEAEs Related to Tislelizumab | 16 Participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of first dose to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Time frame: From the first dose of the study treatment to date of death from any cause (up to 2 years and 9 months)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab and Fruquintinib | Overall Survival (OS) | 10.5 months |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Overall Survival (OS) | 10.0 months |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Overall Survival (OS) | NA months |
Secondary
Progression-Free Survival (PFS) as Assessed by 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 progressive disease (PD) or death, whichever occurs first. Median 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.
Time frame: From date of first dose of study drug until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tislelizumab and Fruquintinib | Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1 | 4.6 months |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1 | 4.6 months |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1 | 15.6 months |