Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) and its US partner Coherus BioSciences Inc., (NASDAQ: CHRS) have announced positive findings from the final analysis of overall survival (OS) in the pivotal Phase III JUPITER-02 (NCT03581786) clinical study. The study assessed the programmed death-1 inhibitor Tuoyi (toripalimab) as a treatment for nasopharyngeal carcinoma (NPC). The final analysis demonstrated a statistically significant and clinically meaningful improvement in OS in NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone. Coherus’ CMO Rosh Dias M.D., noted: “These mature overall survival data clearly show that toripalimab has the potential to become the new standard-of-care for NPC patients, once approved.” Full details will be shared at an upcoming oncology industry summit.
JUPITER-02 Clinical Trial
JUPITER-02 is a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC. According to clinicaltrials.gov, the study recruited 289 patients exclusively across hospitals in mainland China.
Regulatory Milestones
The US FDA previously granted Breakthrough Therapy designation for toripalimab plus chemotherapy in first-line NPC, as well as for toripalimab as a monotherapy in second or third-line treatment of recurrent or metastatic NPC. Coherus and Junshi first filed toripalimab plus chemo for approval in first-line NPC in the US in November 2021, and received a Complete Response Letter in May 2022. A BLA was refiled in July last year with a PDUFA date of December 2022. That regulatory decision has been indefinitely delayed due to last year’s COVID-19 disruptions in China.-Fineline Info & Tech
