Trial Outcomes & Findings for Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors (NCT NCT04716634)

Last Updated: 2025-03-25

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Up to 28 Days

Results posted on

2025-03-25

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Gastric Cancer (GC): Tislelizumab and Fruquintinib Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (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.	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.	PD-L1 + NSCLC: Tislelizumab and Fruquintinib Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (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.
Overall Study STARTED	31	31	22
Overall Study COMPLETED	2	3	7
Overall Study NOT COMPLETED	29	28	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Gastric Cancer (GC): Tislelizumab and Fruquintinib Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (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.	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.	PD-L1 + NSCLC: Tislelizumab and Fruquintinib Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (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.
Overall Study Death	24	24	8
Overall Study Closed by Sponsor	4	4	5
Overall Study Lost to Follow-up	1	0	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Total n=84 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 8.71 • n=5 Participants	58.8 years STANDARD_DEVIATION 7.88 • n=7 Participants	63.5 years STANDARD_DEVIATION 11.28 • n=5 Participants	60.1 years STANDARD_DEVIATION 9.29 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	31 Participants n=7 Participants	22 Participants n=5 Participants	83 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=6 Participants 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.	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.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	—	0 Participants	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: Analysis was performed on the DLT evaluable analysis set.

RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.

Outcome measures

Outcome measures
Measure	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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=6 Participants 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.	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.
Part 1: Recommended Phase 2 Dose (RP2D)	—	5.0 milligrams (mg) per day	—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
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 Interval 20.7 to 63.6	12.9 percentage of participants Interval 3.6 to 29.8	9.7 percentage of participants Interval 2.0 to 25.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1	15.6 months Interval 1.8 to The upper limit of 95% confidence interval (CI) could not be calculated due to fewer number of participants with events.	4.6 months Interval 3.4 to 7.4	4.6 months Interval 3.6 to 7.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1	68.2 percentage of participants Interval 45.1 to 86.1	74.2 percentage of participants Interval 55.4 to 88.1	74.2 percentage of participants Interval 55.4 to 88.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1	59.1 percentage of participants Interval 36.4 to 79.3	32.3 percentage of participants Interval 16.7 to 51.4	38.7 percentage of participants Interval 21.8 to 57.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=9 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=4 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=3 Participants 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.
Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1	NA months Interval 7.7 to Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.	NA months Interval 5.6 to Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.	11.9 months Interval 3.7 to The upper limit of 95% CI could not be calculated due to fewer number of participants with events.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
Overall Survival (OS)	NA months Interval 6.0 to Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.	10.5 months Interval 5.2 to 14.6	10.0 months Interval 4.7 to 15.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PD-L1 + NSCLC: Tislelizumab and Fruquintinib n=22 Participants 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.	Gastric Cancer (GC): Tislelizumab and Fruquintinib n=31 Participants 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.	Colorectal Cancer (CRC): Tislelizumab and Fruquintinib n=31 Participants 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.
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	30 Participants	31 Participants
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	13 Participants	14 Participants
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	18 Participants	21 Participants
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	3 Participants	0 Participants
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	20 Participants	22 Participants
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	25 Participants	26 Participants

Adverse Events

Gastric Cancer (GC): Tislelizumab and Fruquintinib

Serious events: 13 serious events

Other events: 28 other events

Deaths: 24 deaths

Colorectal Cancer (CRC): Tislelizumab and Fruquintinib

Serious events: 14 serious events

Other events: 29 other events

Deaths: 24 deaths

PD-L1 + NSCLC: Tislelizumab and Fruquintinib

Serious events: 13 serious events

Other events: 19 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER