Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine for adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as a monotherapy for adults with recurrent, unresectable, or metastatic NPC who have experienced disease progression following chemotherapy.
The filing is supported by data from the JUPITER-02 (NCT03581786) and POLARIS-02 (NCT02915432) studies, in which patients received 200 mg of toripalimab alongside chemotherapy every three weeks. Results from the JUPITER-02 study indicated that the combination therapy significantly extended progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone, reducing the risk of disease progression or death by 48% and the risk of death by 37%. The POLARIS-02 study demonstrated that toripalimab maintained anti-tumor activity with manageable safety profiles, yielding 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.
Toripalimab, which became China’s first domestically approved PD-1 inhibitor in December 2018 for melanoma, has secured six indication approvals domestically. The drug is currently undergoing over 40 clinical studies across more than 15 indications globally and received approval for two NPC indications in the United States in October.- Flcube.com
