A new breakthrough in the first-line treatment of advanced esophageal cancer: PD-1 monoclonal antibody baizean ® Global phase 3 clinical trials reached the primary end point

On April 28, Baiji Shenzhou announced that its independently developed PD-1 monoclonal antibody baizean ® (tirelizumab) combined with chemotherapy for the treatment of first-line patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC), the global phase 3 clinical trial rationale 306 reached the primary end point of overall survival (OS), which means that patients with advanced ESCC are expected to usher in new treatment options. The published rationale 306 is a randomized, placebo-controlled, double-blind global large-scale phase 3 study to evaluate baizean ® Combined chemotherapy, compared with placebo combined chemotherapy, is effective and safe as a first-line treatment for patients with advanced or metastatic ESCC. The primary endpoint was overall survival (OS). Secondary endpoints included progression free survival, overall remission rate and duration of remission, health-related quality of life indicators, and safety as assessed by RECIST version 1.1. The study was led by Chinese researchers. A total of 649 patients were enrolled in multiple research centers in Asia Pacific, Europe and North America, of which 55% were from Chinese Mainland, 25% from Europe and the United States, and 20% from Japan, South Korea and other countries and regions. This distribution of patients is in line with the characteristics of esophageal squamous cell carcinoma. It is of great significance to understand the value of immunotherapy in the diagnosis and treatment of esophageal squamous cell carcinoma worldwide and analyze the efficacy advantages of immunotherapy in different regions.