A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)

Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: The Intent-To-Treat (ITT) analysis set included all randomized participants in the main study.

An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).

Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)

Population: The Sub-study Safety Analysis Set includes all participants in the safety run-in sub-study who received at least one dose of any study drug.

Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only.

Time frame: Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks).

Population: The Sub-study Pharmacokinetic (PK) Analysis Set includes all participants in the safety run-in sub-study who received at least 1 dose of tislelizumab per the protocol, for whom any post-dose PK data were available at each time point.

The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.

Time frame: Baseline to Cycle 6 (each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both Baseline and Cycle 6 are included.

The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.

Time frame: Baseline to Cycle 6 (each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both Baseline and Cycle 6 are included in the analysis.

The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = Not at all to 4 = Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study.

Time frame: Baseline to Cycle 6 (Each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both baseline and Cycle 6 are included

The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = Not at all to 4 = Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The EORTC QLQ-HCC18 was not assessed for participants in the sub-study.

Time frame: Baseline to Cycle 4 (each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included

The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study.

Time frame: Baseline to Cycle 4 (each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included.

The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study.

Time frame: Baseline to Cycle 4 (each cycle was 21 days)

Population: ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included in the analysis.

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set

Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: ITT Analysis Set

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: ITT Analysis Set

Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders.

Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: Sub-study Safety Analysis Set; Main study ITT Analysis Set; Only participants with best overall response of complete response or partial response per investigator assessment were included in the analysis.

An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).

Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B).

Population: The Safety Analysis Set includes all randomized participants who received at least one dose of any study drug.

Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline. ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set

Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: Sub-study Safety Analysis Set; Main study ITT Analysis Set

Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set

Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: Sub-study Safety Analysis Set; Main study ITT Analysis Set

Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration. ADA assessments were not performed for participants enrolled in the main study.

Time frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)

Population: The Sub-study Antidrug antibody (ADA) Analysis Set includes all participants enrolled in the sub-study who received at least one dose of tislelizumab for whom both baseline ADA and at least one postbaseline ADA results were available.

Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.

Time frame: Up a to 64 months

Population: Sub-study Safety Analysis Set

Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not a pre-specified sub-study endpoint.

Time frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Population: ITT Analysis Set

Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.

Time frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Population: ITT Analysis Set