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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2673 - A Phase 3, Randomized, Open-Label Study to Compare the Efficacy of Tislelizumab Versus Chemotherapy as Second-Line Therapy for Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Tumour Site

Oesophageal Cancer

Presenters

Lin Shen

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

L. Shen1, J.A. Ajani2, S. Kim3, E. van Cutsem4, B. Guo5, J. Song6, V. Paton7, K. Kato8

Author affiliations

  • 1 Gi Oncology, Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 2 Md Anderson Cancer Center, The University of Texas, Houston/US
  • 3 Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 4 Leuven Cancer Institute, University Hospitals Leuven, Leuven/BE
  • 5 Medical Oncology, BeiGene (Beijing) Co., Ltd., Beijing/CN
  • 6 Biometry, BeiGene USA, Inc., Fort Lee/US
  • 7 Clinical Development, BeiGene USA, Inc., Emeryville/US
  • 8 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
More

Resources

Abstract 2673

Background

Approximately 40% of patients (pts) with esophageal cancer are diagnosed with advanced unresectable or metastatic disease; the 5-year survival rate for advanced disease is < 5%. Inhibition of PD-1 has demonstrated antitumor activity and was generally well tolerated in pts with advanced unresectable or metastatic ESCC. Tislelizumab, a humanized IgG4 monoclonal antibody, has high affinity and specificity for PD-1. Tislelizumab was specifically engineered to minimize FcϒR binding on macrophages that, based on preclinical evidence, is believed to minimize potentially negative interactions with other immune cells. A first-in-human study (NCT02407990) demonstrated that single-agent tislelizumab was generally well tolerated and had preliminary antitumor effects in pts with solid tumors, including ESCC. A recommended phase 3 dose of 200 mg administered IV every 3 weeks (Q3W) has been established for tislelizumab.

Trial design

This phase 3, randomized study (NCT03430843) was designed to evaluate the efficacy, safety, and tolerability of tislelizumab compared with chemotherapy for second-line treatment of advanced unresectable/metastatic ESCC. Adult pts, aged ≥18 years, with histologically or cytologically confirmed ESCC that has progressed with first-line therapy, have ≥1 measurable/evaluable lesion, and have an Eastern Cooperative Oncology score ≤1 will be enrolled. Approximately 450 pts will be randomized (1:1) to receive either tislelizumab 200 mg IV Q3W or investigator-chosen chemotherapy (paclitaxel 135–175 mg/m2 IV Q3W or 100 mg/m2 IV weekly for 6 weeks with 1 week of rest [Japan only], docetaxel 75 mg/m2 or 70 mg/m2 IV Q3W, or irinotecan 125 mg/m2 IV Q3W). Overall survival is the primary endpoint; secondary endpoints include objective response rate, progression free survival, duration of response, and health-related quality-of-life outcomes. Safety/tolerability will be assessed by monitoring adverse events (AEs), including immune-related AEs, as well as physical examinations, vital signs, and electrocardiograms. As of 11 April 2018, 6 patients have been enrolled.

Clinical trial identification

NCT03430843.

Legal entity responsible for the study

BeiGene, Ltd.

Funding

BeiGene, Ltd.

Editorial Acknowledgement

Medical writing and editorial assistance was provided by Regina Switzer, PhD (SuccinctChoice Medical Communications, Chicago, IL).

Disclosure

J.A. Ajani: Honoraria, research funding: BWS, Five Prime Therapeutics, Medscape, Celgene, Taiho Pharmaceutical, Merck, Delta-Fly, Gilead. E. Van Cutsem: Consulting role, research funding: Baxter, Lilly, Roche, Servier, Amgen, Bayer, Boehringer, Celgene, MSO, Merck, Novartis, Ipsen, Roche, Sanofi. B. Guo: Employee, ownership interest: BeiGene. J. Song, V. Paton: Employee: BeiGene. K. Kato: Consulting role, speakers' bureau, research funding: Beigene, MSD, Ono Pharmaceutical, BMS, Eli Lilly, Shionogi, Merck Serono. All other authors have declared no conflicts of interest.

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