Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under the trade names Zytorvi and Loqtorzi in India and Hong Kong, respectively. The approved indications include: 1) toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC; 2) toripalimab as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
These approvals are backed by the results from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Phase III clinical study (NCT03581786), which assessed toripalimab in combination with gemcitabine-cisplatin as the first-line treatment of NPC. Additionally, the approvals are supported by the results from POLARIS-02, a multi-center, open-label, pivotal Phase II clinical study (NCT02915432) evaluating toripalimab as the second-line or later treatment for recurrent or metastatic NPC. JUPITER-02 showed that the combination of toripalimab and chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37% in patients compared to chemotherapy alone. The POLARIS-02 study demonstrated that toripalimab exhibited persistent anti-tumor activity and controllable safety in patients with recurrent/metastatic NPC who had previously failed chemotherapy, with an objective response rate (ORR) of 20.5%, a duration of response (DoR) of 12.8 months, and a median overall survival (OS) of 17.4 months.
Toripalimab was the first domestic PD-1 inhibitor approved in China (in December 2018) as a second-line treatment for melanoma, with a total of ten indication approvals in China to date. Over 40 clinical trials for the drug covering more than 15 indications have been initiated, showcasing the drug’s potential in addressing a wide range of cancer types.- Flcube.com
