Coherus Announces Positive Final Overall Survival Results of JUPITER-02 Phase 3 Trial Evaluating Toripalimab in Nasopharyngeal Carcinoma

– Toripalimab plus chemotherapy resulted in a 37% reduction in the risk of death, HR=0.63, versus chemotherapy alone, in nasopharyngeal carcinoma patients –

– No treatments are approved for NPC in the US; if approved, toripalimab will address a critical unmet need –

REDWOOD CITY, Calif., June 05, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced the final overall survival (OS) results of the JUPITER-02 study presented today at the American Society for Clinical Oncology (ASCO) Annual Meeting. JUPITER-02 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

The final analysis of the JUPITER-02 clinical trial (NCT03581786) demonstrated a statistically significant and clinically meaningful improvement in OS for NPC patients who were treated with toripalimab in combination with gemcitabine and cisplatin chemotherapy, versus chemotherapy treatment alone. Median OS has not been reached in the toripalimab arm versus 33.7 months for chemotherapy treatment alone, HR=0.63 (95% CI 0.45-0.89); P=0.0083.

“There are limited options for patients living with this very aggressive form of head and neck cancer. These results are remarkable, with meaningful improvement over chemotherapy alone, and this is practice-changing," said Jennifer Choe, M.D., Ph.D., Assistant Professor of Medicine and the Head and Neck Medical Oncology Disease Team Lead in the Division of Hematology and Oncology at Vanderbilt University Medical Center. "I was impressed with the primary endpoint outcome, extending progression-free survival from 8.2 months with chemotherapy alone to 21.4 months with the addition of toripalimab, and now with the strong overall survival data, this will be a new standard of care for patients, if approved.”

Rosh Dias, M.D., Coherus’ Chief Medical Officer, echoed Dr. Choe's remarks, “This landmark trial demonstrates a significant survival advantage for patients with recurrent or metastatic nasopharyngeal carcinoma who were treated with toripalimab. No other PD-1 inhibitor currently approved in the U.S. has had a successful Phase 3 trial in recurrent or metastatic NPC that met its primary endpoints. Toripalimab, therefore, addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and we look forward to bringing this important medicine to patients upon approval.”