China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab. The anti-PD-1 monoclonal antibody can now be used 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 monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Clinical Trial Results
The TGA’s decision was based on results from the Phase III JUPITER-02 study for toripalimab in first-line NPC and the Phase II POLARIS-02 study for the drug as second-line or later treatment of NPC. The results showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (PFS) in the toripalimab combination group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. Additionally, patients treated with the combined therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%. No new safety signals were identified. Long-term survival follow-up data presented at ASCO 2024 showed a 5-year survival rate of 52%.
Toripalimab’s Regulatory Milestones
Toripalimab was China’s first domestic PD-1 inhibitor to be approved (in December 2018) as a second-line treatment for melanoma. The drug has previously received ten indication approvals in China. It was also approved in Hong Kong in October of last year for recurrent unresectable or metastatic NPC, further expanding its reach in the Asia-Pacific region.-Fineline Info & Tech
