- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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