A priority review was granted to toripalimab by the FDA for 2 indications in patients with advanced nasopharyngeal carcinoma.
A biologics license application (BLA) for the combination of toripalimab (Tuoyi) plus gemcitabine and cisplatin for patients with advanced recurrent or metastatic nasopharyngeal carcinoma was accepted by the FDA and granted priority review, according to a press release from developer Junshi Biosciences.1 The BLA also covered the use of toripalimab monotherapy for the treatment of recurrent or metastatic disease following a platinum-containing regimen in the second line and beyond.
The application for the anti–PD-1 monoclonal antibody is supported by findings from both the phase 2 POLARIS-02 trial (NCT02915432), which assessed toripalimab in previously treated and recurrent or metastatic nasopharyngeal carcinoma, and the phase 3 JUPITER-02 trial (NCT03581786), examining gemcitabine and cisplatin with or without toripalimab in recurrent of metastatic nasopharyngeal carcinoma.2,3 POLARIS-02 revealed durable clinical responses in those treated with toripalimab and JUPITER-02 identified notable improvements in progression-free survival (PFS).
The Prescription Drug User Fee Act action date is currently set for April 2022.
“We are excited by the continued progress of toripalimab toward a first marketing authorization outside of China,” Patricia Keegan, chief medical officer at Junshi Biosciences, said in a press release. “With the earlier approval in China, toripalimab became the world’s first immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma, bringing a novel therapy to a disease that has long lacked new drug development. We will cooperate closely with our partner, Coherus, to leverage the FDA’s Priority Review designation to accelerate the completion of the BLA review and believe toripalimab, if approved, will bring an important new treatment option for NPC patients in the United States.”
Patients enrolled on the POLARIS-02 trial received 3 mg/kg of intravenous toripalimab once every 2 weeks until experiencing disease progression or unacceptable toxicity. In the population of 190 patients, investigators reported an overall response rate of 20.5%, including a median duration of response of 12.8 months. Additionally, patients experienced a median PFS of 1.9 months and a median overall survival (OS) of 17.4 months.
A regimen consisting of either 240 mg of toripalimab and gemcitabine plus cisplatin every 3 weeks for 6 treatment cycles followed by subsequent toripalimab maintenance at 240 mg every 3 weeks or matched placebo was utilized in the JUPITER-02 trial. Those who received the toripalimab regimen achieved a median PFS of 11.7 months compared with 8.0 months among those who received chemotherapy alone (stratified HR, 0.52; 95% CI, 0.36-0.74; P = .0003). Investigators also reported that the median OS was not evaluable in either arm (stratified HR, 0.603).
“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,” Denny Lanfear, chief executive officer at Coherus, concluded. “Toripalimab is the PD-1 cornerstone of our immuno-oncology strategy, and we are pleased that the FDA has accepted the BLA for review. Including the toripalimab application, Coherus now has three product candidate BLAs under review by the FDA, and our team is making rapid progress toward our goal to diversify and expand our commercial product portfolio.”