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A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Phase 3 trial testing Tislelizumab in Esophageal Squamous Cell Carcinoma (ESCC) in 512 participants. Completed in 28 December 2022.
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 512 |
| Start date | 26 January 2018 |
| Primary completion | 1 December 2020 |
| Estimated completion | 28 December 2022 |
| Sites | 104 locations across France, Italy, Japan, Belgium, Taiwan, United Kingdom, Germany, South Korea |
BeiGene — full company profile →
18 and older, any sex, with Esophageal Squamous Cell Carcinoma (ESCC). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 8.6 | 7.5 – 10.4 |
| Investigator Chosen Chemotherapy | 6.3 | 5.3 – 7.0 |
OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 10.2 | 8.5 – 14.5 |
| Investigator Chosen Chemotherapy | 5.1 | 3.8 – 8.2 |
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 20.3 | 15.6 – 25.8 |
| Investigator Chosen Chemotherapy | 9.8 | 6.4 – 14.1 |
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 26.3 | 17 – 37.3 |
| Investigator Chosen Chemotherapy | 11.3 | 4.7 – 21.9 |
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 1.6 | 1.4 – 2.7 |
| Investigator Chosen Chemotherapy | 2.1 | 1.5 – 2.7 |
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 2.7 | 1.5 – 4.2 |
| Investigator Chosen Chemotherapy | 2.3 | 1.4 – 3.0 |
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 7.1 | 4.1 – 11.3 |
| Investigator Chosen Chemotherapy | 4.0 | 2.1 – 8.2 |
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 7.1 | 2.9 – 13.2 |
| Investigator Chosen Chemotherapy | 5.7 | 1.2 – NA |
Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 16.2 | ± 12.28 |
| Investigator Chosen Chemotherapy | 18.3 | ± 13.86 |
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 0.2 | ± 8.28 |
| Investigator Chosen Chemotherapy | 4.8 | ± 9.38 |
Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 16.8 | ± 10.96 |
| Investigator Chosen Chemotherapy | 18.8 | ± 12.02 |
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 0.5 | ± 7.39 |
| Investigator Chosen Chemotherapy | 0.5 | ± 4.86 |
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 14.7 | ± 11.81 |
| Investigator Chosen Chemotherapy | 16.3 | ± 13.20 |
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | -0.6 | ± 8.63 |
| Investigator Chosen Chemotherapy | 3.0 | ± 12.05 |
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | 16.5 | ± 12.69 |
| Investigator Chosen Chemotherapy | 18.1 | ± 12.21 |
| Group | Value | 95% CI |
|---|---|---|
| Tislelizumab | -0.9 | ± 7.45 |
| Investigator Chosen Chemotherapy | -2.9 | ± 5.16 |
Time frame: All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tislelizumab | Investigator Chosen Chemot… |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Oesophageal obstruction | Gastrointestinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Death | General disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Septic shock | Infections and infestations | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Oesophageal stenosis | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — |
| Pneumonia aspiration | Infections and infestations | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Tislelizumab | Investigator Chosen Chemot… |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Weight decreased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Asthenia | General disorders | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Malaise | General disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
Most-reported serious reactions: Pneumonia, Dysphagia, Neutrophil count decreased, Febrile neutropenia, Diarrhoea, White blood cell count decreased, Decreased appetite, Oesophageal obstruction.
Data from ClinicalTrials.gov NCT03430843 adverse events section.
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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