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

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)

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)

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)

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)

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)

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.