Junshi PD-1 combined with chemotherapy for first-line esophageal squamous cell carcinoma phase III clinical reach the primary endpoint

On April 22, Junshi Biopharmaceuticals issued an announcement that the phase III clinical study of teriprizumab combined with paclitaxel/cisplatin in the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma reached the main research endpoint, and plans to communicate and submit a marketing application in the near future.

The JUPITER-06 study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, which aims to compare teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in the advanced stage or metastasis Efficacy and safety of first-line treatment for esophageal squamous cell carcinoma.

The JUPITER-06 study actually enrolled 514 patients.

According to the results of the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the two main research endpoints of the study had reached the pre-specified superiority cut-off value for the progression-free survival and overall survival.

Esophageal cancer is a malignant tumor that originates in the epithelium of the esophageal mucosa and is one of the most common tumors in the world.

Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer.

According to the Insight database, the imported K drug for PD-1 and Hengrui's Karelizumab have been approved for esophageal cancer indications.

Progress of PD-1 mAbs under development for indications for esophageal cancer in China

Image source: Insight database (https://db.