Trial Outcomes & Findings for A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC (NCT NCT04948697)

Last Updated: 2025-02-24

Results Overview

ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (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 less than (\<) 10 millimeters (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

94 participants

Primary outcome timeframe

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

Results posted on

2025-02-24

Participant Flow

A total of 94 eligible participants were randomized in a 2:1 ratio to receive ociperlimab in combination with tislelizumab + BAT1706 or tislelizumab + BAT1706.

Randomization was stratified according to programmed cell death protein-ligand 1 (PD-L1) expression and macrovascular invasion (MVI)/extrahepatic spread (EHS) (present versus absent) status.

Participant milestones

Participant milestones
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Study STARTED	62	32
Overall Study Treated	62	31
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	62	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Study Progressive disease	27	18
Overall Study Adverse Event	14	4
Overall Study Participant moved to long term extension study	7	4
Overall Study Withdrawal by Subject	10	0
Overall Study Closed by Sponsor	3	2
Overall Study Physician Decision	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Other-Miscellaneous	1	0
Overall Study Randomized but not treated	0	1

Baseline Characteristics

A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Total n=94 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 11.27 • n=5 Participants	59.1 years STANDARD_DEVIATION 10.77 • n=7 Participants	58.6 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	30 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	32 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	62 Participants n=5 Participants	32 Participants n=7 Participants	94 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Macrovascular invasion (MVI) Status Present	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Macrovascular invasion (MVI) Status Absent	49 Participants n=5 Participants	20 Participants n=7 Participants	69 Participants n=5 Participants
Extrahepatic spread (EHS) Status Present	31 Participants n=5 Participants	19 Participants n=7 Participants	50 Participants n=5 Participants
Extrahepatic spread (EHS) Status Absent	31 Participants n=5 Participants	13 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

Population: Analysis was performed on the Intent-to-Treat (ITT) analysis set that included all randomized participants and were analyzed according to their randomized treatment arm (i.e., Arm A or Arm B).

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Objective Response Rate (ORR) as Assessed by the Investigator	37.1 percentage of participants Interval 25.2 to 50.3	40.6 percentage of participants Interval 23.7 to 59.4

SECONDARY outcome

Timeframe: From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)

Population: Analysis was performed on participants in the ITT analysis set with an objective response.

DOR was defined as the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease or death whichever comes first, assessed based on RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1, 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	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=23 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=13 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Duration Of Response (DOR) as Assessed by the Investigator	12.6 months Interval 6.9 to Upper limit of 95% confidence interval (CI) could not be estimated due to low number of participants with an event.	12.4 months Interval 5.4 to Upper limit of 95% CI could not be estimated due to low number of participants with an event.

SECONDARY outcome

Timeframe: From the randomization date to the first documentation of response (up to 27 months)

Population: Analysis was performed on participants in the ITT analysis set with an objective response.

TTR was defined as the time from the randomization date to the date of first documented partial response (PR) or better by the investigator, assessed based on RECIST v1.1. 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	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=23 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=13 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Time to Response (TTR) as Assessed by the Investigator	2.76 months Interval 1.2 to 6.9	4.17 months Interval 1.4 to 8.3

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

Population: Analysis was performed on ITT analysis set.

DCR was defined as the percentage of participants who achieve complete response (CR), partial response (PR) or stable disease (SD), assessed based on 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	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Disease Control Rate (DCR) as Assessed by the Investigator	77.4 percentage of participants Interval 65.0 to 87.1	71.9 percentage of participants Interval 53.3 to 86.3

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

Population: Analysis was performed on ITT analysis set.

CBR was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as \>= 24 weeks). Per RECIST 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.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Clinical Benefit Rate (CBR) as Assessed by the Investigator	59.7 percentage of participants Interval 46.4 to 71.9	56.3 percentage of participants Interval 37.7 to 73.6

SECONDARY outcome

Timeframe: From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)

Population: Analysis was performed on ITT analysis set.

PFS was evaluated by the investigator according to RECIST version 1.1; and was defined as the time from the randomization date to the date of first documentation of disease progression or date of death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v 1.1, 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	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Progression-Free Survival (PFS) as Assessed by the Investigator	8.3 months Interval 5.5 to 10.3	6.9 months Interval 4.1 to 17.4

SECONDARY outcome

Timeframe: From the randomization date until the date of death from any cause (up to 27 months)

Population: Analysis was performed on ITT analysis set.

OS was defined as the time from the randomization date until the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=32 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Overall Survival (OS)	19.7 months Interval 18.4 to Upper limit of 95% CI was not calculated due to low number of participants with events.	22.9 months Interval 14.4 to Upper limit of 95% CI was not calculated due to low number of participants with events.

SECONDARY outcome

Timeframe: From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months)

Population: Analysis was performed on safety analysis set that included all participants of each arm who received at least 1 dose of study drugs.

A TEAE was defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) and up to 30 days after the last dose of study drug(s), or initiation of new anticancer therapy, whichever occurs first. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0, 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	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=31 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAEs	62 Participants	31 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Serious TEAEs	31 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAEs >= Grade 3	48 Participants	17 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAEs Leading to Treatment Discontinuation	18 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAEs Leading to Death Excluding Death Due to Disease Under Study	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

Population: Analysis was performed on Pharmacokinetics (PK) analysis set that included all participants who received at least 1 dose of any component of study drugs as per the protocol, and for whom any post dose PK data was available. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit.

Serum samples were assayed for ociperlimab concentrations using a validated immunoassay. This outcome measure was not analyzed for Arm B as ociperlimab was not administered in Arm B.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=61 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Serum Concentrations of Ociperlimab Cycle 1 Day 1: Pre-dose	0.00 micrograms per milliliters (mcg/mL) Standard Deviation 0.000	—
Serum Concentrations of Ociperlimab Cycle 1 Day 1: Post-dose	287.15 micrograms per milliliters (mcg/mL) Standard Deviation 50.203	—
Serum Concentrations of Ociperlimab Cycle 2 Day 1: Pre-dose	39.82 micrograms per milliliters (mcg/mL) Standard Deviation 16.896	—
Serum Concentrations of Ociperlimab Cycle 5 Day 1: Pre-dose	68.23 micrograms per milliliters (mcg/mL) Standard Deviation 28.422	—
Serum Concentrations of Ociperlimab Cycle 5 Day 1: Post-dose	385.22 micrograms per milliliters (mcg/mL) Standard Deviation 79.227	—
Serum Concentrations of Ociperlimab Cycle 9 Day 1: Pre-dose	79.83 micrograms per milliliters (mcg/mL) Standard Deviation 30.614	—
Serum Concentrations of Ociperlimab Cycle 17 Day 1: Pre-dose	78.16 micrograms per milliliters (mcg/mL) Standard Deviation 29.558	—
Serum Concentrations of Ociperlimab Safety Follow-up: Post Dose	34.54 micrograms per milliliters (mcg/mL) Standard Deviation 28.961	—

SECONDARY outcome

Population: Analysis was performed on PK analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure and "number analyzed" signifies participants with available data for each specified category at respective visit.

Serum samples were assayed for tislelizumab concentrations using a validated immunoassay.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=61 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=30 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Serum Concentrations of Tislelizumab Cycle 1 Day 1: Pre-dose	0.00 micrograms per milliliters (mcg/mL) Standard Deviation 0.000	0.00 micrograms per milliliters (mcg/mL) Standard Deviation 0.000
Serum Concentrations of Tislelizumab Cycle 1 Day 1: Post-dose	69.63 micrograms per milliliters (mcg/mL) Standard Deviation 11.923	67.69 micrograms per milliliters (mcg/mL) Standard Deviation 12.545
Serum Concentrations of Tislelizumab Cycle 2 Day 1: Pre-dose	19.65 micrograms per milliliters (mcg/mL) Standard Deviation 6.348	17.70 micrograms per milliliters (mcg/mL) Standard Deviation 5.875
Serum Concentrations of Tislelizumab Cycle 5 Day 1: Pre-dose	38.14 micrograms per milliliters (mcg/mL) Standard Deviation 13.908	36.62 micrograms per milliliters (mcg/mL) Standard Deviation 11.920
Serum Concentrations of Tislelizumab Cycle 5 Day 1: Post-dose	106.93 micrograms per milliliters (mcg/mL) Standard Deviation 22.321	103.21 micrograms per milliliters (mcg/mL) Standard Deviation 21.305
Serum Concentrations of Tislelizumab Cycle 9 Day 1: Pre-dose	43.82 micrograms per milliliters (mcg/mL) Standard Deviation 16.823	42.00 micrograms per milliliters (mcg/mL) Standard Deviation 16.495
Serum Concentrations of Tislelizumab Cycle 17 Day 1: Pre-dose	39.35 micrograms per milliliters (mcg/mL) Standard Deviation 14.060	44.01 micrograms per milliliters (mcg/mL) Standard Deviation 21.788
Serum Concentrations of Tislelizumab Safety Follow-up: Post Dose	23.90 micrograms per milliliters (mcg/mL) Standard Deviation 16.674	25.66 micrograms per milliliters (mcg/mL) Standard Deviation 26.011

SECONDARY outcome

Population: Analysis was performed on PK analysis set. Here, "number analyzed" signifies participants with available data for each specified category at respective visit.

Serum samples were assayed for BAT1706 concentrations using a validated immunoassay.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=62 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=31 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Serum Concentrations of BAT1706 Cycle 2 Day 1: Pre-dose	63.28 micrograms per milliliters (mcg/mL) Standard Deviation 19.302	55.30 micrograms per milliliters (mcg/mL) Standard Deviation 20.999
Serum Concentrations of BAT1706 Cycle 5 Day 1: Pre-dose	113.97 micrograms per milliliters (mcg/mL) Standard Deviation 37.045	112.79 micrograms per milliliters (mcg/mL) Standard Deviation 34.114
Serum Concentrations of BAT1706 Cycle 17 Day 1: Pre-dose	111.29 micrograms per milliliters (mcg/mL) Standard Deviation 31.055	123.36 micrograms per milliliters (mcg/mL) Standard Deviation 44.184
Serum Concentrations of BAT1706 Safety Follow-up: Post Dose	59.74 micrograms per milliliters (mcg/mL) Standard Deviation 40.020	81.42 micrograms per milliliters (mcg/mL) Standard Deviation 79.696
Serum Concentrations of BAT1706 Cycle 1 Day 1: Pre-dose	0.00 micrograms per milliliters (mcg/mL) Standard Deviation 0.000	0.00 micrograms per milliliters (mcg/mL) Standard Deviation 0.000
Serum Concentrations of BAT1706 Cycle 1 Day 1: Post-dose	319.29 micrograms per milliliters (mcg/mL) Standard Deviation 58.599	321.03 micrograms per milliliters (mcg/mL) Standard Deviation 56.151
Serum Concentrations of BAT1706 Cycle 5 Day 1: Post-dose	432.60 micrograms per milliliters (mcg/mL) Standard Deviation 86.670	410.71 micrograms per milliliters (mcg/mL) Standard Deviation 90.747
Serum Concentrations of BAT1706 Cycle 9 Day 1: Pre-dose	113.72 micrograms per milliliters (mcg/mL) Standard Deviation 38.039	120.55 micrograms per milliliters (mcg/mL) Standard Deviation 43.141

SECONDARY outcome

Timeframe: Up to 27 months

Population: Analysis was performed on the Immunogenicity analysis set that included all participants who received at least 1 dose of any component of study drugs and for whom both baseline ADA and \>=1 post-baseline ADA result was available. Here, "0" in the number analyzed field signifies that participants in Arm B were not assessed for anti-ociperlimab ADAs since they did not receive ociperlimab.

Serum samples were tested for the presence of ADAs to ociperlimab, tislelizumab and BAT1706 using a validated immunoassay. The analysis included: Treatment-emergent ADA: sum of treatment-boosted ADA patients and treatment-induced ADA participants as a percentage of the ADA-evaluable participants population; Treatment-boosted ADA: Baseline-positive ADA-evaluable patients with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period; and Treatment-induced ADA: ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period.

Outcome measures

Outcome measures
Measure	Arm A: Ociperlimab + Tislelizumab + BAT1706 n=57 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.	Arm B: Tislelizumab + BAT1706 n=29 Participants Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment boosted ADA: Ociperlimab	0 Participants	—
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment-emergent ADA: Tislelizumab	22 Participants	18 Participants
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment induced ADA: Tislelizumab	21 Participants	16 Participants
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment induced ADA: BAT1706	1 Participants	3 Participants
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment-emergent ADA: Ociperlimab	1 Participants	—
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment induced ADA: Ociperlimab	1 Participants	—
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment boosted ADA: Tislelizumab	1 Participants	2 Participants
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment-emergent ADA: BAT1706	1 Participants	3 Participants
Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706 Treatment boosted ADA: BAT1706	0 Participants	0 Participants

Adverse Events

Arm A: Ociperlimab + Tislelizumab + BAT1706

Serious events: 31 serious events

Other events: 61 other events

Deaths: 28 deaths

Arm B: Tislelizumab + BAT1706

Serious events: 12 serious events

Other events: 31 other events

Deaths: 14 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