Coherus and Junshi toripalimab ph 3 NPC trials

Coherus and Junshi Biosciences published the results of Ph III trials of toripalimab in JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”).  Coherus reported that final analysis demonstrated a statistically significant and clinically meaningful improvement in overall survival  in NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone.  The FDA has granted Breakthrough Therapy designation (and associated regulatory expedition) for toripalimab for the indications relating to use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.