Coherus, Junshi announces publication of OS results from JUPITER-02 study

Coherus BioSciences and Shanghai Junshi Biosciences announced the publication of the final overall survival results from the pivotal JUPITER-02 study, a randomized, double-blind, placebo-controlled, international, multi-center Phase 3 clinical trial evaluating the immune checkpoint inhibitor LOQTORZI, in combination with the chemotherapy agents gemcitabine and cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma in the Journal of the American Medical Association. As previously reported at the 2023 American Society of Clinical Oncologists Annual Meeting, the final analysis revealed a 37% reduction in the risk of death in NPC patients treated with toripalimab plus chemotherapy versus chemotherapy alone. In October, Coherus and Junshi announced the U.S. Food and Drug Administration approval of LOQTORZI in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Coherus plans to launch LOQTORZI in the United States in January 2024. Titled Toripalimab plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma, the paper highlights the addition of LOQTORZI to gemcitabine-cisplatin chemotherapy as first-line treatment for patients with recurrent or metastatic NPC provided superior OS compared to GP alone. The median OS was not reached in the LOQTORZI arm and was 33.7 months in the placebo arm. The 2-year and 3-year OS rates were 78.0% vs. 65.1%, and 64.5% vs. 49.2% respectively. A consistent effect on OS, favoring the LOQTORZI arm, was observed in the majority of the subgroups, including PD-L1 expression and EBV copy number high and low subgroups. The addition of LOQTORZI to chemotherapy also provided superior progression-free survival compared to chemotherapy alone, with a median PFS of 21.4 vs. 8.2 months. The safety profile was consistent with that previously reported in other toripalimab clinical trials and consistent with the PD-1 inhibitor class.