Junshi Biosciences, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. This is the first approval of immune checkpoint blockade therapy in NPC in the world and the second approved indication for toripalimab in China. In December 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of unresectable or metastatic melanoma.

In April 2020, the supplemental NDA for Toripalimab in patients with recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy was accepted by the NMPA and received priority review designation from the NMPA in July 2020. The supplemental NDA is based on the POLARIS-02 study (NCT02915432), which is a multi-center, open-label, Phase II pivotal registrational clinical study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The study enrolled a total of 190 patients with recurrent or metastatic NPC after failure of prior systemic therapy. The POLARIS-02 study is the world’s largest clinical study for any immune checkpoint inhibitor monotherapy for the treatment of recurrent or metastatic NPC. In January 2021, the results of the POLARIS-02 study were published online in the Journal of Clinical Oncology.

The results of the POLARIS-02 study showed that Toripalimab demonstrated durable anti-tumor activity and survival benefits regardless of PD-L1 expression status with a manageable safety profile. In 92 patients with recurrent/metastatic NPC after failure of at least two lines of prior systemic chemotherapy, the objective response rate (ORR) was 23.9%; the median duration of response (mDOR) 14.9 months; and the median overall survival (mOS) 15.1 months.

"The great variability in prevalence of NPC across the globe is evident, which leads to challenges in new drug research and development on a global scale. Despite this, unmet medical needs for NPC remain globally. Our data show that NPC is clearly responsive to immunotherapy. It is notable that toripalimab lacks the usual side effects of cytotoxic therapy and is generally well tolerated by patients, showing a great potential for further development in the treatment of NPC," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences.

"As an innovation-driven pharma who follows the ‘In China, For Global’ strategy, we focus on tumor types that are 1) highly prevalent in China; 2) responsive to immunotherapy; and 3) where there is urgent unmet need for better and safer treatments. We sincerely appreciate the contributions made by investigators and patients of the POLARIS-02 study, empowering us to obtain this critical medical evidence to advance treatment options for so many. In addition, we have also developed a R & D program for treatment of NPC, regardless of extent of prior treatment, and look forward to providing better treatment options for patients with advanced nasopharyngeal carcinoma in China and beyond."