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

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.

Time frame: 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).

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.

Time frame: 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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: From the randomization date until the date of death from any cause (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.

Time frame: 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.

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

Time frame: 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 PK analysis set. Here, 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.

Time frame: 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 tislelizumab concentrations using a validated immunoassay.

Time frame: 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 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.

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.

Time frame: 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.