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Coherus Reports Positive Results From Phase3 Toripalimab Trial On Esophageal Squamous Cell Carcinoma

Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences Inc. (CHRS) said an interim results from Phase 3 clinical trial has provided strong evidence that addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic esophageal squamous cell carcinoma patients has superior progression free survival and overall survival than chemotherapy alone.

The company said it looks forward to updated analyses of overall survival of the JUPITER-06 study in the future. It believes that those results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic esophageal squamous cell carcinoma.

The pivotal study "JUPITER-06" (NCT03829969) is a randomized, double-blind, placebo-controlled Phase 3 clinical trial, which evaluates toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival and overall survival for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic esophageal squamous cell carcinoma.

In China, the supplemental New Drug Application of the indication has been accepted by the National Medical Products Administration in July, 2021.

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