Trial Outcomes & Findings for A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma (NCT NCT03783442)

Last Updated: 2025-07-29

Results Overview

Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

649 participants

Primary outcome timeframe

From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Results posted on

2025-07-29

Participant Flow

This study was conducted at 162 centers in 16 countries/regions across Asia, Europe, North America, and Oceania.

Participants were randomly assigned (1:1), using an interactive response technology system, to either tislelizumab plus investigator-chosen chemotherapy or placebo plus investigator-chosen chemotherapy. Randomization was stratified by investigator-chosen chemotherapy (platinum plus fluoropyrimidine vs platinum plus paclitaxel), region (Asia \[excluding Japan\] vs Japan vs other regions), and previous definitive therapy (yes vs no).

Participant milestones

Participant milestones
Measure	Tislelizumab + Chemotherapy Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).	Placebo + Chemotherapy Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).
Overall Study STARTED	326	323
Overall Study Treated	324	321
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	326	323

Reasons for withdrawal

Reasons for withdrawal
Measure	Tislelizumab + Chemotherapy Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).	Placebo + Chemotherapy Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).
Overall Study Death	252	268
Overall Study Withdrawal by Subject	19	21
Overall Study Lost to Follow-up	7	6
Overall Study Sponsor Ended Study	48	28

Baseline Characteristics

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tislelizumab + Chemotherapy n=326 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=323 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Total n=649 Participants Total of all reporting groups
Age, Continuous	64.0 years n=5 Participants	65.0 years n=7 Participants	64.0 years n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	42 Participants n=7 Participants	86 Participants n=5 Participants
Sex: Female, Male Male	282 Participants n=5 Participants	281 Participants n=7 Participants	563 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	243 Participants n=5 Participants	243 Participants n=7 Participants	486 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	79 Participants n=5 Participants	76 Participants n=7 Participants	155 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Geographic Region Asia (excluding Japan)	210 Participants n=5 Participants	210 Participants n=7 Participants	420 Participants n=5 Participants
Geographic Region Japan	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Geographic Region Rest of World	83 Participants n=5 Participants	80 Participants n=7 Participants	163 Participants n=5 Participants
Prior Definitive Therapy Yes	152 Participants n=5 Participants	150 Participants n=7 Participants	302 Participants n=5 Participants
Prior Definitive Therapy No	174 Participants n=5 Participants	173 Participants n=7 Participants	347 Participants n=5 Participants
Investigator Chosen Chemotherapy Platinum with Fluoropyrimidine	147 Participants n=5 Participants	146 Participants n=7 Participants	293 Participants n=5 Participants
Investigator Chosen Chemotherapy Platinum with Paclitaxel	179 Participants n=5 Participants	177 Participants n=7 Participants	356 Participants n=5 Participants
Programmed Cell Death Protein Ligand-1 (PD-L1) Expression PD-L1 Score ≥ 10%	116 Participants n=5 Participants	107 Participants n=7 Participants	223 Participants n=5 Participants
Programmed Cell Death Protein Ligand-1 (PD-L1) Expression PD-L1 Score < 10%	151 Participants n=5 Participants	168 Participants n=7 Participants	319 Participants n=5 Participants
Programmed Cell Death Protein Ligand-1 (PD-L1) Expression Unknown	59 Participants n=5 Participants	48 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Population: The ITT analysis set included all randomized participants

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=326 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=323 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Overall Survival (OS)	17.2 months Interval 15.8 to 20.1	10.6 months Interval 9.3 to 12.1

SECONDARY outcome

Timeframe: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Population: ITT Analysis Set

Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=326 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=323 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Progression-Free Survival (PFS)	7.3 months Interval 6.9 to 8.3	5.6 months Interval 4.9 to 6.0

SECONDARY outcome

Timeframe: Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Population: ITT Analysis Set

ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022).

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=326 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=323 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Objective Response Rate (ORR)	63.5 percentage of participants Interval 58.0 to 68.7	42.4 percentage of participants Interval 37.0 to 48.0

SECONDARY outcome

Timeframe: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Population: ITT Analysis Set participants with PD-L1 score ≥ 10%

OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=116 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=107 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10%	16.6 months Interval 15.3 to 24.4	10.0 months Interval 8.6 to 13.3

SECONDARY outcome

Timeframe: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Population: Participants in the ITT Analysis Set with an objective response

DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=207 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=137 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Duration of Response (DOR)	7.1 months Interval 6.1 to 8.1	5.7 months Interval 4.4 to 7.1

SECONDARY outcome

Timeframe: Baseline, Cycle 6 (Week 15)

Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement.

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 (trouble swallowing saliva, 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 as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=310 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=309 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores Dysphagia	-0.5 score on a scale Interval -4.7 to 3.7	-4.9 score on a scale Interval -9.4 to -0.5
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores Eating	-0.9 score on a scale Interval -3.1 to 1.3	-1.5 score on a scale Interval -3.8 to 0.9
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores Reflux	-1.3 score on a scale Interval -3.2 to 0.7	0.2 score on a scale Interval -1.9 to 2.2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores Pain	-5.2 score on a scale Interval -6.7 to -3.7	-3.3 score on a scale Interval -4.9 to -1.8
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores Index Score	-1.0 score on a scale Interval -2.2 to 0.3	-0.6 score on a scale Interval -1.9 to 0.7

SECONDARY outcome

Timeframe: Baseline, Cycle 6 (Week 15)

Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement.

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 to 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	Tislelizumab + Chemotherapy n=310 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=309 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales Global Health Status/ QOL	-0.3 score on a scale Interval -2.3 to 1.8	-3.6 score on a scale Interval -5.8 to -1.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales Physical Functioning	-4.8 score on a scale Interval -6.6 to -3.0	-7.3 score on a scale Interval -9.2 to -5.4

SECONDARY outcome

Timeframe: Baseline, Cycle 6 (Week 15)

Population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement.

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 to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=310 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=309 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Change From Baseline in EORTC QLQ-C30 Fatigue Scale	8.0 score on a scale Interval 5.7 to 10.4	9.4 score on a scale Interval 6.9 to 11.9

SECONDARY outcome

Timeframe: Baseline, Cycle 6 (Week 15)

Population: Participants in the ITT Analysis Set with EQ-5D-5L measurement at both Baseline and Cycle 6.

The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=221 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=196 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS)	-1.1 score on a scale Standard Deviation 15.82	-3.1 score on a scale Standard Deviation 14.01

SECONDARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months.

Population: Safety analysis set included all participants who received at least 1 dose of study drug

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 met any of the following criteria: * 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.

Outcome measures

Outcome measures
Measure	Tislelizumab + Chemotherapy n=324 Participants Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.	Placebo + Chemotherapy n=321 Participants Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment-emergent adverse event	323 Participants	319 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious adverse events	160 Participants	128 Participants

Adverse Events

Tislelizumab + Chemotherapy

Serious events: 160 serious events

Other events: 321 other events

Deaths: 252 deaths

Placebo + Chemotherapy

Serious events: 128 serious events

Other events: 314 other events

Deaths: 268 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