FDA Issues Complete Response Letter to Toripalimab BLA in Metastatic Nasopharyngeal Carcinoma


The biologic license application for toripalimab plus chemotherapy for the treatment of recurrent or metastatic nasopharyngeal carcinoma is expected to be resubmitted by mid-summer 2023.

The FDA has issued a complete response letter to a biologic license application (BLA) for toripalimab (Tuoyi) in combination with chemotherapy for the treatment of patients with recurrent or advanced nasopharyngeal carcinoma, according to a press release from Shanghai Junshi Biosciences and Coherus Biosciences.1

Due to the impact of COVID-19 travel restrictions in China, the FDA was unable to conduct an on-site inspection of the manufacturing facility for toripalimab, which is a requirement for the application’s review. The application remains under review as the agent’s manufacturers continue to discuss pre-approval inspection plans with the FDA.

“There is a significant unmet need for those living with [nasopharyngeal carcinoma], and toripalimab has demonstrated significant and clinically meaningful improvement as recognized by the FDA’s breakthrough therapy designation,” Theresa LaVallee, PhD, chief development officer at Coherus, said in the press release. “We are working closely and collaboratively with the FDA to schedule inspections of the manufacturing facility quickly and understand the need to ensure the safety of their inspectors.”

Previously, the FDA accepted the BLA for toripalimab and it granted priority in November 2021.2 The application was supported by findings from the phase 2 POLARIS-02 trial (NCT02915432), in which patients treated with toripalimab had an overall response rate of 20.5% with a median duration of response of 12.8 months.3 Additionally, the median progression-free survival (PFS) and median overall survival rates, respectively, were 1.9 months and 17.4 months.

Patients enrolled on the POLARIS-02 trial received 3 mg/kg of intravenous toripalimab every 2 weeks until disease progression or unacceptable toxicity.

The application for toripalimab was also supported by data from the phase 3 JUPITER-02 trial (NCT03581786), in which the median PFS among patients receiving toripalimab plus chemotherapy was 11.7 months vs 8.0 months among those in the placebo arm (HR, 0.52; 95% CI, 0.36-0.74; P = .0003).4

Patients in the JUPITER-02 trial either received 240 mg of toripalimab and gemcitabine plus cisplatin every 3 weeks for 6 cycles followed by 240 mg of toripalimab maintenance every 3 weeks or matched placebo.

Following a complete response letter in May 2022, the application for toripalimab was resubmitted and accepted by the FDA in July 2022.5 The revised application was submitted after the FDA requested quality process changes.

“Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary. We are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in order to provide patients [with nasopharyngeal carcinoma] with a treatment that has been demonstrated to be safe and effective,” Sheng Yao, PhD, senior vice president of Junshi Biosciences, concluded.


  1. Coherus and Junshi Biosciences share update on the FDA Review of the biologics license application (BLA) for toripalimab as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Junshi Biosciences and Coherus Biosciences. December 24, 2022. Accessed January 3, 2023. https://bit.ly/3IgTMIU
  2. Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma. News release. Junshi Biosciences. November 1, 2021. Accessed January 3, 2023. https://bit.ly/3CDYbjj
  3. Wang FH, Wei XL, 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. 2021;39(7):704-712. doi:10.1200/JCO.20.02712
  4. Xu R-H, Mai H-Q, Chen Q-Y, et al. JUPITER-02: the randomized, double-blind phase 3 study of toripalimab or placebo plus cisplatin and gemcitabine as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). J Clin Oncol. 2021;39(suppl 15):LBA2. doi:10.1200/JCO.2021.39.15_suppl.LBA2
  5. Coherus and Junshi Biosciences receive complete response letter from U.S. FDA for toripalimab BLA. News release. Coherus and Shanghai Junshi Biosciences. May 2, 2022. Accessed January 3, 2023. https://yhoo.it/3MKS9SB

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