Trial Outcomes & Findings for Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma (NCT NCT04401800)

Last Updated: 2025-03-10

Results Overview

ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Results posted on

2025-03-10

Participant Flow

The study was conducted at 9 study sites in China.

The study consisted of two parts: Part 1 (Safety run-in part) and Part 2 (Extension part). Results were planned to be reported and analyzed combined for Part 1 (safety-run) and Part 2 of the study as all participants received the same treatment.

Participant milestones

Participant milestones
Measure	Lenvatinib With Tislelizumab Participants received lenvatinib based on baseline weight (12 milligrams \[mg\] or 8 mg once daily for participants with a baseline weight of \>= 60 kilograms \[kg\] or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Study STARTED	64
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenvatinib With Tislelizumab Participants received lenvatinib based on baseline weight (12 milligrams \[mg\] or 8 mg once daily for participants with a baseline weight of \>= 60 kilograms \[kg\] or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Study Death	17
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenvatinib With Tislelizumab n=64 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Age, Continuous	51.1 years STANDARD_DEVIATION 11.24 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	64 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) which included all dosed participants with measurable disease at baseline per RECIST v1.1 and who had at least one evaluable post-baseline tumor assessment unless treatment was discontinued due to clinical disease progression or death before the first post-treatment tumor assessment.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1	38.7 percentage of participants Interval 26.6 to 51.9

SECONDARY outcome

Timeframe: From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months)

Population: Analysis was performed on safety analysis set which included all participants who received at least 1 dose of any study drug (any component for the combination therapy).

A TEAE was defined as adverse event (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 occurs first determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. SAE: 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.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=64 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification TEAE	64 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification TESAE	11 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification TEAE leading to treatment discontinuation	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification TEAE leading to dose modification	37 Participants

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. 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.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1	41.9 percentage of participants Interval 29.5 to 55.2

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. Per modified RECIST (mRECIST), CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) By investigator	46.8 percentage of participants Interval 34.0 to 59.9
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) By Central Site Imaging Facility	46.8 percentage of participants Interval 34.0 to 59.9

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

ORR was defined as the percentage of participants achieving the BOR of immune complete response (iCR) or partial response (iPR). The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST) By investigator	43.5 percentage of participants Interval 31.0 to 56.7
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST) By Central Site Imaging Facility	38.7 percentage of participants Interval 26.6 to 51.9

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurred earlier). DOR was estimated using the Kaplan-Meier method. 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. Progressive disease 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	Lenvatinib With Tislelizumab n=26 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) 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 Median and 95% Confidence Interval (CI) could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=24 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1	NA months Median and 95% CI could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. PD: an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=29 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST	9.7 months Interval 5.6 to Upper limit of 95% CI could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=29 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST	NA months Median and 95% CI could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

DOR was defined as the time interval between the date of the earliest qualifying response (iCR or iPR) and the date of confirmed progressive disease (iCPD) or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. 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. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=27 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST	NA months Interval 9.7 to Median and Upper limit of 95% CI could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurs first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF) on the subset of participants with a response.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=24 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST	NA months Median and 95% CI could not be calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. 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. Stable Disease (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	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1 By investigator	85.5 percentage of participants Interval 74.2 to 93.1
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1 By Central Site Imaging Facility	90.3 percentage of participants Interval 80.1 to 96.4

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable disease (SD): any cases that do not qualify for either partial response or progressive disease.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST By investigator	85.5 percentage of participants Interval 74.2 to 93.1
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST By Central Site Imaging Facility	90.3 percentage of participants Interval 80.1 to 96.4

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

DCR was defined as the percentage of participants with BOR of iCR, iPR or immune stable disease (iSD). Participants without post-baseline tumor assessment were considered a failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST By investigator	88.7 percentage of participants Interval 78.1 to 95.3
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST By Central Site Imaging Facility	90.3 percentage of participants Interval 80.1 to 96.4

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

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 PD or death, whichever occurred first. 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	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1	9.6 months Interval 5.3 to Upper limit of 95% CI could not be calculated due to low number of participants with PFS events.

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1	8.2 months Interval 6.8 to Upper limit of 95% CI could not be calculated due to low number of participants with PFS events.

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

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 PD or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per mRECIST, PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST	6.9 months Interval 4.2 to 9.6

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST	8.3 months Interval 6.7 to Upper limit of 95% CI could not be calculated due to low number of participants with PFS events.

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

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 (iCPD) or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per iRECIST 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. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST	11.1 months Interval 6.8 to Upper limit of 95% CI could not be calculated due to low number of participants with PFS events.

SECONDARY outcome

Timeframe: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)

Population: Analysis was performed on Efficacy-Evaluable Analysis Set (EFF).

Outcome measures

Outcome measures
Measure	Lenvatinib With Tislelizumab n=62 Participants Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST	8.2 months Interval 6.8 to Upper limit of 95% CI could not be calculated due to low number of participants with PFS events.

Adverse Events

Tislelizumab + Lenvatinib

Serious events: 11 serious events

Other events: 63 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Tislelizumab + Lenvatinib n=64 participants at risk Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Eye disorders Retinal detachment	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Duodenal ulcer perforation	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Immune-mediated enterocolitis	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Pancreatitis	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Pancreatitis acute	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Small intestinal haemorrhage	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
General disorders Death	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Hepatobiliary disorders Hepatic function abnormal	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Infections and infestations Abdominal infection	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Nervous system disorders Dizziness	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Nervous system disorders Hepatic encephalopathy	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Nervous system disorders Paraplegia	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Renal and urinary disorders Ureterolithiasis	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 1/64 • Number of events 1 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.

Other adverse events

Other adverse events
Measure	Tislelizumab + Lenvatinib n=64 participants at risk Participants received lenvatinib based on baseline weight (12 mg or 8 mg once daily for participants with a baseline weight of \>= 60 kg or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Blood and lymphatic system disorders Anaemia	4.7% 3/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Blood and lymphatic system disorders Leukopenia	4.7% 3/64 • Number of events 7 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Blood and lymphatic system disorders Thrombocytopenia	4.7% 3/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Cardiac disorders Sinus bradycardia	4.7% 3/64 • Number of events 5 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Endocrine disorders Hyperthyroidism	4.7% 3/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Endocrine disorders Hypothyroidism	31.2% 20/64 • Number of events 20 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Endocrine disorders Thyroid disorder	6.2% 4/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Endocrine disorders Thyroid mass	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Abdominal pain	9.4% 6/64 • Number of events 6 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Abdominal pain lower	3.1% 2/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Abdominal pain upper	3.1% 2/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Ascites	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Diarrhoea	17.2% 11/64 • Number of events 18 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Gingival swelling	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Stomatitis	6.2% 4/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Gastrointestinal disorders Toothache	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
General disorders Fatigue	9.4% 6/64 • Number of events 8 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
General disorders Pyrexia	6.2% 4/64 • Number of events 7 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Hepatobiliary disorders Hepatic function abnormal	7.8% 5/64 • Number of events 7 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Infections and infestations Pharyngitis	4.7% 3/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Infections and infestations Pneumonia	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Infections and infestations Upper respiratory tract infection	4.7% 3/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Infections and infestations Urinary tract infection	7.8% 5/64 • Number of events 5 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Alanine aminotransferase increased	12.5% 8/64 • Number of events 9 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Amylase increased	17.2% 11/64 • Number of events 15 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Aspartate aminotransferase increased	34.4% 22/64 • Number of events 25 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Bilirubin conjugated increased	4.7% 3/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood alkaline phosphatase increased	12.5% 8/64 • Number of events 9 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood bilirubin increased	18.8% 12/64 • Number of events 20 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood chloride decreased	4.7% 3/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood creatine phosphokinase MB increased	15.6% 10/64 • Number of events 20 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood creatine phosphokinase increased	12.5% 8/64 • Number of events 12 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood creatinine increased	3.1% 2/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood lactate dehydrogenase increased	17.2% 11/64 • Number of events 14 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Blood thyroid stimulating hormone increased	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations C-reactive protein increased	7.8% 5/64 • Number of events 11 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Electrocardiogram ST segment abnormal	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Electrocardiogram ST-T change	4.7% 3/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Electrocardiogram T wave abnormal	6.2% 4/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Gamma-glutamyltransferase increased	10.9% 7/64 • Number of events 7 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Glomerular filtration rate decreased	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Lipase increased	18.8% 12/64 • Number of events 14 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Lymphocyte count decreased	6.2% 4/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Neutrophil count decreased	9.4% 6/64 • Number of events 11 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Platelet count decreased	26.6% 17/64 • Number of events 28 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Prealbumin decreased	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Thyroid function test abnormal	4.7% 3/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Total bile acids increased	6.2% 4/64 • Number of events 8 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Urinary occult blood positive	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations Weight decreased	31.2% 20/64 • Number of events 24 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Investigations White blood cell count decreased	12.5% 8/64 • Number of events 14 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Metabolism and nutrition disorders Decreased appetite	7.8% 5/64 • Number of events 5 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Metabolism and nutrition disorders Hyperkalaemia	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Metabolism and nutrition disorders Hyperuricaemia	4.7% 3/64 • Number of events 6 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 4/64 • Number of events 7 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Metabolism and nutrition disorders Hyponatraemia	6.2% 4/64 • Number of events 4 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	6.2% 4/64 • Number of events 5 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Musculoskeletal and connective tissue disorders Myositis	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Nervous system disorders Headache	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Psychiatric disorders Insomnia	3.1% 2/64 • Number of events 2 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Renal and urinary disorders Haematuria	10.9% 7/64 • Number of events 15 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Renal and urinary disorders Proteinuria	45.3% 29/64 • Number of events 60 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Dysphonia	10.9% 7/64 • Number of events 8 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.1% 2/64 • Number of events 3 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	20.3% 13/64 • Number of events 13 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Skin and subcutaneous tissue disorders Pruritus	6.2% 4/64 • Number of events 5 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Skin and subcutaneous tissue disorders Rash	12.5% 8/64 • Number of events 9 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.
Vascular disorders Hypertension	35.9% 23/64 • Number of events 31 • All-cause mortality data were collected through the end of the study, up to 35 months. Adverse events were collected from first dose up to 30 days after last dose; maximum time on treatment was 12 months Analysis was performed on safety analysis set.

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