Coherus meets endpoints in Phase 3 esophageal cancer trial

 Coherus BioSciences, Inc. (Nasdaq: CHRS) has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled.

The interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

https://finance.yahoo.com/news/coherus-announces-toripalimab-achieved-primary-120000233.html