BeiGene, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, announced that the first patient was dosed in a global phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, as a potential second-line treatment in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Tislelizumab is also being studied in global phase 3 trials in non-small cell lung cancer and hepatocellular carcinoma and two pivotal phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer.
“We are pleased to be leading the third global phase 3 study of tislelizumab under our strategic collaboration with Celgene. These studies are designed to support regulatory filings both in China and globally, and take advantage of our unique global clinical development organization as well as the recent regulatory reforms in China. In 2018, we look forward to further expanding the development program for tislelizumab and to accomplishing key milestones including a planned NDA submission in China,” commented John V. Oyler, Founder, chief executive officer, and chairman of BeiGene.
“Patients with advanced unresectable or metastatic esophageal carcinomas face poor prognosis, especially those with squamous histology, due to the extremely aggressive nature of the disease. We are hopeful that this phase 3 trial will establish safety and efficacy of tislelizumab as an important treatment option for these patients,” commented Amy Peterson, M.D., chief medical officer, Immuno-Oncology, at BeiGene.
The phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab compared to investigator-chosen chemotherapy as a second-line treatment in patients with advanced unresectable or metastatic ESCC. Approximately 450 patients are planned to be enrolled in Greater China, Japan, Korea, Belgium, France, Germany, Italy, Spain, the United Kingdom and the United States. Patients will be randomized to receive either tislelizumab at 200 mg every three weeks or one of three single-agent chemotherapies, paclitaxel, docetaxel, or irinotecan, as determined by the investigator.
The trial’s primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life, safety, and tolerability.
“Treatment options for esophageal squamous cell carcinoma have been limited to chemotherapy. Tislelizumab has shown promising anti-tumor activity and has been generally well-tolerated in clinical trials to date in patients with a variety of cancers, including esophageal cancer, and we are hopeful that data from this phase 3 trial will lead to a new treatment option where it is so greatly needed,” said Professor Lin Shen, M.D., vice president at the Beijing Cancer Hospital, Beijing, China, and lead investigator of the trial.