Phase III JUPITER-02 study shows positive results for toripalimab in nasopharyngeal carcinoma
Shanghai Junshi Biosciences and Coherus BioSciences announced positive results of a final analysis of overall survival from the pivotal study JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating Tuoyi (toripalimab in combination with gemcitabine and cisplatin) as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma
This final analysis demonstrated a statistically significant and clinically meaningful improvement in OS in NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone.
This builds upon data published in Nature Medicine and presented at the 2021 plenary session at the ASCO annual meeting in patients with advanced NPC, an aggressive head and neck tumor with no current FDA-approved treatment options. These data are being submitted for presentation at an upcoming medical meeting. Compared to chemotherapy alone, a combination containing the immune checkpoint inhibitor, toripalimab, shows it can extend the life in patients with NPC.
See; Mai HQ, Chen QY, Chen D et al. "Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase III trial". Nat Med. 2021, 27:1536 doi:10.1038/s41591-021-01444-0 PMID:34341578