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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 (ClinicalTrials.gov Identifier: NCT02915432) and phase 3 JUPITER-02 studies (ClinicalTrials.gov 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.
References
- 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. https://www.globenewswire.com/news-release/2021/11/01/2324275/0/en/Junshi-Biosciences-and-Coherus-Announce-FDA-Acceptance-of-BLA-Filing-for-Toripalimab-for-Treatment-of-Nasopharyngeal-Carcinoma.html.
- 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.
- 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.
