To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors

Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Population: Safety Analysis Set: Participants who received ≥ 1 dose of study drug(s) Evaluable Analysis Set: Participants who received ≥ 1 dose of study drug(s), have evaluable disease at baseline, and have ≥ 1 evaluable postbaseline tumor response assessment unless any clinical progressive disease or death occurred before the first postbaseline tumor assessment.

An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.

Time frame: From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.

Population: The Safety run-in set is defined as all participants in the safety run-in stage.

DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference.

Time frame: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Population: Evaluable analysis set and Safety Analysis Set

DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.

Time frame: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Population: Evaluable Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in this analysis,

An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug.

Time frame: From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months)

Population: Safety Analysis Set

OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.

Time frame: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Population: Safety Analysis Set

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Time frame: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Population: Safety analysis set