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Coherus and Junshi Biosciences Announce Toripalimab in Combination with Chemotherapy Met Primary Progression Free Survival (PFS) Endpoint as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
– In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1 expression subgroups – – Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo – – Data to be presented June 6, 2021 at ASCO plenary session – – Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021 – SHANGHAI, China and REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive results from the pivotal study “JUPITER-02”, a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) compared to chemotherapy alone (assessed by a blinded independent review committee, or BIRC, per RECIST v1.1). JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate (ORR) assessed by BIRC. There was also a longer duration of response (DoR), a higher disease control rate (DCR) and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials. The results are summarized in a late-breaking abstract that will be presented during a plenary session at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) on Sunday, June 6, 2021 from 1–4 pm Eastern Daylight Time. The abstract (LBA2) is now available on the ASCO website. “Nasopharyngeal carcinoma is an aggressive tumor—especially for patients with advanced NPC. For first line treatment, platinum-based chemotherapy remains the current standard of care, yet mPFS is only about 7 months. We are encouraged by the JUPITER-02 results showing the addition of toripalimab to chemotherapy as first-line treatment provided superior PFS and ORR and longer DoR than chemotherapy alone, and with a safety and...