Junshi Biosciences announced that the Independent Data Monitoring Committee (IDMC) has determined that toripalimab in combination with paclitaxel/cisplatin as the first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) has reached its pre-specified primary endpoints of Progression Free Survival (PFS) and Overall Survival (OS) at the interim analysis of the randomized, double-blind, placebo-controlled, multi-center, phase III clinical study “JUPITER-06”. Junshi Biosciences will communicate with the regulatory authorities regarding the supplemental New Drug Application (sNDA) in the near future.
Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium, which is one of the most common cancers in the world. According to data released by GLOBOCAN 2020, esophageal cancer is the seventh most common malignant tumor in the world and the sixth leading cause of cancer death. In 2020, approximately 320,000 new esophageal cancer cases and approximately 300,000 deaths due to esophageal cancer occurred in China, with the incidence and death rates ranking fifth and fourth among all malignant tumors, respectively. Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer. Esophageal squamous cell carcinoma is the main subtype in China, accounting for 90% of all esophageal cancer. For patients with advanced esophageal squamous cell carcinoma, the current standard first-line treatment is platinum based chemotherapy, but the 5-year overall survival rate is less than 20%.
The JUPITER-06 study was a randomized, double-blind, placebo-controlled, multicenter phaseIII trial that aimed to compare the efficacy and safety of toripalimab combined with paclitaxel/cisplatin versus placebo combined with paclitaxel/cisplatin as first-line treatments for advanced esophageal squamous cell carcinoma. Professor Ruihua Xu from the Sun Yat-sen University Cancer Hospital is the principal investigator of the JUPITER-06 study. A total of 514 patients were enrolled in the study. The primary endpoints were progression-free survival (PFS) as assessed by the Blinded Independent Review Committee (BICR) and overall survival (OS). Secondary endpoints included the PFS assessed by investigator, objective response rate (ORR), disease control rate (DCR) and duration of response (DOR).
Based on the results of interim analysis, the Independent Data Monitoring Committee (IDMC) determined that both primary endpoints of PFS and OS have crossed the prespecified efficacy boundaries and the results show that compared with the paclitaxel/cisplatin chemotherapy , toripalimab combined with paclitaxel/cisplatin significantly prolonged the PFS and OS of patients with advanced esophageal squamous carcinoma.
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States.