FDA Issues Complete Response Letter to Toripalimab for Advanced Nasopharyngeal Carcinoma


Plans to resubmit a biologics license application for toripalimab as treatment of advanced recurrent or metastatic nasopharyngeal carcinoma have been made for midsummer 2022 following receipt of a complete response letter from the FDA.

The FDA has issued a complete response letter for a biologics license application (BLA) for toripalimab (Tuoyi) plus gemcitabine and cisplatin as treatment of patients with first-line advanced recurrent or metastatic nasopharyngeal carcinoma and single-agent toripalimab for recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy in the second line and beyond, according to a press release from Coherus and Shanghai Junshi Biosciences.1

The complete response letter detailed a need for a quality process change that should be feasible, according to the agent’s developers. Coherus and Shanghai Junshi Biosciences intend to work directly with the FDA with the goal of resubmitting the BLA by midsummer 2022. The timeline for the resubmission will be approximately 6 months, as onsite inspections have been impacted by the COVID-19 pandemic in China, the complete response letter stated.

“We will continue to work closely with our partner, Junshi Biosciences, to facilitate the completion of the FDA’s review of the toripalimab BLA. In late April, we responded quickly to an FDA request for a quality process change and implemented required actions,” Denny Lanfear, chief executive officer at Coherus, said in the press release. “We plan to first meet with the FDA and directly thereafter to resubmit the BLA. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions. We believe toripalimab addresses an important unmet need for patients with [nasopharyngeal carcinoma] for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data.”

The first-line toripalimab/chemotherapy combination therapy was granted priority review by the FDA in November 2021 for patients with advance nasopharyngeal cancer.2 The designation was based in part on findings from the phase 3 JUPITER-02 trial (NCT03581786), which assessed toripalimab in combination with gemcitabine and cisplatin vs chemotherapy alone in the aforementioned indication. Findings from the trial highlighted a median progression-free survival (PFS) benefit in the toripalimab arm by blinded independent review committee, at 11.7 months (95% CI, 11.0­-not reached) vs 8.0 months (95% CI, 7.0-9.5) in the control group (HR, 0.52; 95% CI, 0.36-0.74; P = .0003).3

Additionally, the BLA was supported by the phase 2 POLARIS-02 trial (NCT02915432), assessing toripalimab in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma.4 The study yielded durable clinical responses among those treated with toripalimab, including an overall response rate of 20.5% and a median duration of response of 12.8 months.

“Junshi Biosciences is dedicated to the discovery, development, and commercialization of innovative new drugs on a global scale. Toripalimab, our PD-1 inhibitor, has demonstrated a compelling clinical profile in studies across multiple tumor types and is currently approved in China for 4 indications. We fully support our partner, Coherus, in its efforts to seek toripalimab approval in the United States for advanced nasopharyngeal carcinoma, as well as in the subsequent commercial launch, if approved. Our respective teams are working diligently together in a well-coordinated effort to achieve these goals as partners ,” Ning Li, PhD, chief executive officer at Junshi Biosciences, concluded.


  1. 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 May 3, 2022. https://yhoo.it/3MKS9SB
  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 May 3, 2022. https://bit.ly/3CDYbjj
  3. 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
  4. 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
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