Coherus' Toripalimab/Chemo Combo Cuts Death Risk By 37% In Nasopharyngeal Cancer Patients

Coherus BioSciences Inc CHRS announced the final overall survival (OS) results of the JUPITER-02 Phase 3 study of toripalimab in combination with gemcitabine and cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).
The data were presented at the American Society for Clinical Oncology Annual Meeting.
The final analysis demonstrated a statistically significant and clinically meaningful improvement in OS for NPC patients treated with toripalimab combined with gemcitabine and cisplatin chemotherapy versus chemotherapy treatment alone.
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Toripalimab plus chemotherapy resulted in a 37% reduction in the risk of death, HR=0.63, versus chemotherapy alone, in nasopharyngeal carcinoma patients.
Median OS was not reached in the toripalimab arm versus 33.7 months for chemotherapy alone.
The FDA is currently reviewing the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma.
In May 2023, FDA completed the required pre-licensing inspection of partner Shanghai Junshi Biosciences Ltd's toripalimab manufacturing site in China.
Coherus projects potential approval in Q3 2023 and plans to launch toripalimab in the U.S. directly if approved.
No new safety signals were identified in the toripalimab arm.
Price Action: CHRS shares are up 6.02% at $5.28 on the last check Tuesday.

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