Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has submitted market approval applications in Singapore for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug is proposed for use as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin/gemcitabine, and as a monotherapy for recurrent, unresectable, or metastatic NPC that has progressed during or after previous platinum-based therapy. The Health Sciences Authority (HSA) of Singapore is currently evaluating these applications.
The submissions were made through Project Orbis and are supported by the findings of two significant studies: the randomized, double-blind, placebo-controlled, global multi-center Phase III JUPITER-02 study for first-line NPC, and the multi-center, open-label, pivotal Phase II POLARIS-02 study for second-line and above recurrent or metastatic NPC. The JUPITER-02 study demonstrated that the combination of toripalimab with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone, with a median PFS of 21.4 months and a 3-year OS rate of 64.5%. This combination reduced the risk of disease progression or death by 48% and the risk of death by 37%, while maintaining a favorable safety profile. The POLARIS-02 study indicated that toripalimab provided sustained anti-tumor activity and manageable safety in patients with recurrent/metastatic NPC who had previously failed 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.
As China’s first domestically developed PD-1 inhibitor, toripalimab was approved in December 2018 for second-line treatment of melanoma and has since received seven indication approvals in China. The drug is also awaiting regulatory decisions for three additional indications in China and received approval for two NPC indications in the United States in October of last year.- Flcube.com
