Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the Drug Office, Department of Health, the Government of the Hong Kong Special Administrative Region (“DO”) has recently accepted the New Drug Application (“NDA”) for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC”), and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

The NDA is supported by results from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study (NCT03581786) that examined toripalimab in combination with gemcitabine-cisplatin as the first-line treatment of NPC, as well as results from POLARIS-02, a multi-center, open-label, pivotal Phase 2 clinical study (NCT02915432) that evaluated toripalimab as the second-line or later treatment for recurrent or metastatic NPC.

Results from JUPITER-02, the first international, multi-center, double-blind, randomized, placebo-controlled Phase 3 clinical study using immunotherapy for the treatment of NPC with the largest sample size, were presented at the plenary session of the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2), and published in Nature Medicine and the Journal of the American Medical Association (JAMA). The study found that compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatment of metastatic or recurrent NPC significantly improved progression-free survival (“PFS”) and overall survival (“OS”), with a median PFS of 21.4 months and a 3-year OS rate of 64.5%. Toripalimab plus chemotherapy also reduced the risk of disease progression or death by 48% and the risk of death by 37%, all while demonstrating a manageable safety profile.

The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology. These findings showed that toripalimab demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a median duration of response (DoR) of 12.8 months, and a median OS of 17.4 months while maintaining a manageable safety profile.

So far, toripalimab has been approved for marketing in the Chinese mainland and the US. Several NDAs are currently under regulatory review in the European Union, UK, Australia, Singapore, Malaysia and Hong Kong Special Administrative Region (“SAR”). Furthermore, NDAs for toripalimab have also been submitted in India, South Africa, Chile and Jordan.