Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority - Seite 2

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%; it 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 7 indications in China, with 3 supplementary new drug applications (sNDA) currently under regulatory review. Internationally, it has been approved for 2 NPC indications in the US, and marketing approval applications are currently under regulatory review in the European Union, UK, Australia and Singapore.

About NPC

NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancer. According to the World Health Organization, the number of newly diagnosed NPC cases in 2020 exceeded 130,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option, while radiotherapy alone or in combination with chemotherapy are the main treatment options for localized cancers.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.