The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application for toripalimab, in combination with gemcitabine and cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for toripalimab monotherapy as second-line or above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.

The application is supported by data from the phase 2 POLARIS-02 ( Identifier: NCT02915432) and phase 3 JUPITER-02 studies ( Identifier: NCT03581786).

The multicenter, open-label POLARIS-02 trial evaluated the antitumor activity and safety of toripalimab in 190 adults with recurrent or metastatic nasopharyngeal carcinoma refractory to standard chemotherapy. Patients received toripalimab via intravenous infusion once every 2 weeks until confirmed disease progression or unacceptable toxicity. 

Results showed an objective response rate (ORR) of 20.5% with a median duration of response (DOR) of 12.8 months; median progression-free survival (PFS) was 1.9 months and median overall survival was 17.4 months. Among 92 patients who failed at least 2 lines of systemic chemotherapy, the ORR was 23.9%.

The multicenter, randomized, double-blind, placebo-controlled JUPITER-02 study evaluated the efficacy and safety of toripalimab in combination with gemcitabine and cisplatin as first-line treatment in 289 adults with locally advanced, recurrent or metastatic nasopharyngeal carcinoma.

Patients were randomly assigned 1:1 to receive either toripalimab or placebo in combination with gemcitabine and cisplatin every 3 weeks for up to 6 cycles, followed by monotherapy with toripalimab or placebo every 3 weeks until disease progression, intolerable toxicity, or completion of 2 years of treatment.

Findings from JUPITER-02 showed that patients in the toripalimab arm had a significant improvement in PFS compared with the placebo arm (hazard ratio [HR], 0.52; 95% CI, 0.36-0.74; two-sided P =.0003); the median PFS was 11.7 months with toripalimab vs 8.0 months with placebo. The ORR was 77.4% and 66.4% for toripalimab and placebo, respectively (P =.033); median DOR was 10.0 months for toripalimab vs 5.7 months for placebo (HR, 0.50; 95% CI, 0.33-0.78). 

“Nasopharyngeal carcinoma is an aggressive tumor that currently has no FDA-approved immuno-oncology treatment options, and we believe that toripalimab in combination with chemotherapy, if approved, will establish a new standard of care for first line treatment of advanced NPC,” said Denny Lanfear, CEO of Coherus. “Toripalimab is the PD-1 cornerstone of our immuno-oncology strategy, and we are pleased that the FDA has accepted the BLA for review.”

The FDA previously granted Breakthrough Therapy designation for toripalimab for both indications. A Prescription Drug User Fee Act target date of April 2022 has been set for this application.


  1. Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma. News release. Junshi Biosciences. Accessed November 1, 2021.
  2. Wang FH, Wei SL, Feng J, et al. Efficacy, safety, and correlative biomarkers of toripalimab in previously treated recurrent or metastatic nasopharyngeal carcinoma: a phase II clinical trial (POLARIS-02). J Clin Oncol. Published online January 25, 2021. doi: 10.1200/JCO.20.02712
  3. Xu RH, Mai HQ, Chen QY, et al. JUPITER-02: Randomized, double-blind, phase III study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). J Clin Oncol. Published online June 16, 2021. doi: 10.1200/JCO.2021.39.15_suppl.LBA2.