Trial Outcomes & Findings for Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (NCT NCT04732494)

Last Updated: 2025-01-31

Results Overview

Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

125 participants

Primary outcome timeframe

Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Results posted on

2025-01-31

Participant Flow

The study was conducted at 52 study centers in 7 countries/regions in Chinese mainland, Chinese Taiwan, South Korea, Thailand, France, Spain, and Russia.

Participants were randomized equally to one of two treatment groups. Randomization was stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 versus 1), number of organs with metastases (≤ 1 versus ≥ 2), and region (Asia versus non-Asia).

Participant milestones

Participant milestones
Measure	Arm A: Tislelizumab Plus Ociperlimab Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Overall Study STARTED	62	63
Overall Study Received Treatment Plan	62	63
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	62	63

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Tislelizumab Plus Ociperlimab Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Overall Study Death	39	36
Overall Study Study Closed by Sponsor	20	15
Overall Study Withdrawal by Subject	2	7
Overall Study Lost to Follow-up	1	5

Baseline Characteristics

Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Total n=125 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	27 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	36 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	61.4 years STANDARD_DEVIATION 7.31 • n=5 Participants	63.6 years STANDARD_DEVIATION 7.33 • n=7 Participants	62.5 years STANDARD_DEVIATION 7.38 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	53 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	56 Participants n=5 Participants	54 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 (Fully active)	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1 (Restricted but ambulatory)	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants
Number of Organs With Metastases ≤ 1 organ	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Number of Organs With Metastases ≥ 2 organs	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region Asia	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Region Non-Asia	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Population: The Intent-to-Treat (ITT) Analysis Set included all randomized participants.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Objective Response Rate (ORR) Assessed by the Investigator	30.6 percentage of participants Interval 19.6 to 43.7	20.6 percentage of participants Interval 11.5 to 32.7

SECONDARY outcome

Timeframe: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.

Population: The Intent-to-Treat Analysis Set

Overall survival (OS) is defined as the time from the date of randomization until the date of death due to any cause. Median overall survival was estimated using the Kaplan-Meier method. For participants who were still alive at the end of the trial, OS was censored at the last known alive date or the date of data cutoff, whichever was earlier.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Overall Survival	10.2 months Interval 7.9 to 19.5	9.3 months Interval 6.4 to 14.8

SECONDARY outcome

Timeframe: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Population: The Intent-to-Treat Analysis Set

Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Objective Response Rate Assessed by the Independent Review Committee	32.3 percentage of participants Interval 20.9 to 45.3	25.4 percentage of participants Interval 15.3 to 37.9

SECONDARY outcome

Timeframe: From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Population: The Intent-to-Treat (ITT) Analysis Set

Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Progression-free Survival (PFS) Assessed by the Independent Review Committee	3.6 months Interval 2.7 to 5.1	2.8 months Interval 1.9 to 6.9

SECONDARY outcome

Timeframe: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.

Population: The Intent-to-Treat (ITT) Analysis Set

Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Progression-free Survival (PFS) Assessed by the Investigator	3.4 months Interval 1.8 to 5.1	3.4 months Interval 1.9 to 4.1

SECONDARY outcome

Population: Participants in the Intent-to-Treat Analysis Set who had an objective response per IRC assessment.

Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=20 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=16 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Duration Of Response (DOR) Assessed by the Independent Review Committee	14.6 months Interval 7.2 to Could not be estimated due to the low number of events	NA months Interval 4.2 to Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.

Population: Participants in the Intent-to-Treat Analysis Set who had an objective response per Investigator assessment.

Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=19 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=14 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Duration Of Response (DOR) Assessed by the Investigator	11.3 months Interval 5.7 to Could not be estimated due to the low number of events	NA months Interval 4.1 to Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Population: The Intent-to-Treat (ITT) Analysis Set

Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the IRC and the investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Disease Control Rate Assessed by the IRC And the Investigator Investigator assessment	61.3 percentage of participants Interval 48.1 to 73.4	58.7 percentage of participants Interval 45.6 to 71.0
Disease Control Rate Assessed by the IRC And the Investigator Independent Review Committee	64.5 percentage of participants Interval 51.3 to 76.3	58.7 percentage of participants Interval 45.6 to 71.0

SECONDARY outcome

Timeframe: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Population: The Intent-to-Treat (ITT) Analysis Set

Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the IRC and the Investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Durable SD: Stable disease for ≥ 24 weeks. Response (CR or PR) must have been confirmed 4 weeks or later after the first response.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Clinical Benefit Rate Assessed by the IRC and the Investigator Investigator Assessment	33.9 percentage of participants Interval 22.3 to 47.0	30.2 percentage of participants Interval 19.2 to 43.0
Clinical Benefit Rate Assessed by the IRC and the Investigator Independent Review Committee	32.3 percentage of participants Interval 20.9 to 45.3	27.0 percentage of participants Interval 16.6 to 39.7

SECONDARY outcome

Timeframe: Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)

Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=50 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=48 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores Global Health Status/QOL: Cycle 5	1.7 score on a scale Interval -5.6 to 8.9	-0.1 score on a scale Interval -7.5 to 7.4
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores Global Health Status/QOL: Cycle 7	0.3 score on a scale Interval -5.6 to 6.1	-2.8 score on a scale Interval -8.8 to 3.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores Physical Functioning: Cycle 5	-0.5 score on a scale Interval -4.3 to 3.3	1.2 score on a scale Interval -2.8 to 5.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores Physical Functioning: Cycle 7	-4.4 score on a scale Interval -11.2 to 2.5	-3.9 score on a scale Interval -11.0 to 3.3

SECONDARY outcome

Timeframe: Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)

Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at baseline; participants with available data at baseline and the relevant post-baseline visit are included in the analysis at each time point.

The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (saliva swallowing, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=52 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=48 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Dysphagia: Cycle 5	-5.9 score on a scale Interval -14.2 to 2.4	4.1 score on a scale Interval -4.7 to 12.8
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Dysphagia: Cycle 7	-3.5 score on a scale Interval -15.4 to 8.5	7.3 score on a scale Interval -5.2 to 19.8
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Eating: Cycle 5	-1.6 score on a scale Interval -6.6 to 3.3	-1.3 score on a scale Interval -6.6 to 4.1
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Eating: Cycle 7	-2.8 score on a scale Interval -9.1 to 3.6	6.6 score on a scale Interval -0.2 to 13.4
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Reflux: Cycle 5	1.9 score on a scale Interval -4.6 to 8.3	-0.4 score on a scale Interval -7.1 to 6.4
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Reflux: Cycle 7	2.7 score on a scale Interval -4.8 to 10.1	4.0 score on a scale Interval -3.8 to 11.8
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Pain: Cycle 5	0.1 score on a scale Interval -5.5 to 5.6	-0.7 score on a scale Interval -6.5 to 5.1
Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales Pain: Cycle 7	-2.1 score on a scale Interval -7.1 to 3.0	3.3 score on a scale Interval -2.0 to 8.5

SECONDARY outcome

Timeframe: From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.

Population: The Safety Analysis Set included all patients who received ≥ 1 dose of any component of study drugs.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement. AEs were considered "related" to study drugs if there was evidence to suggest a causal relationship. The investigator assessed the severity of each AE reported based upon National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, where ≥ 3 includes severe or medically significant, life-threatening events or death related to AE. Immune-mediated AEs were diagnosed by the investigator.

Outcome measures

Outcome measures
Measure	Arm A: Tislelizumab Plus Ociperlimab n=62 Participants Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Arm B: Tislelizumab Plus Placebo n=63 Participants Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Any TEAE	58 Participants	60 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE ≥ Grade 3	28 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Serious AEs	27 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Related SAEs	13 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs Leading to Treatment Discontinuation	9 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs Leading to Death (Excluding Due to Disease Under Study)	4 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Any Immune-Mediated AE	31 Participants	21 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Immune-Mediated AE ≥ Grade 3	8 Participants	3 Participants

Adverse Events

Arm A: Tislelizumab Plus Ociperlimab

Serious events: 27 serious events

Other events: 57 other events

Deaths: 39 deaths

Arm B: Tislelizumab Plus Placebo

Serious events: 28 serious events

Other events: 54 other events

Deaths: 36 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene, Ltd.

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