Junshi Biosciences and TopAlliance Biosciences announced that toripalimab, their self-developed anti-PD-1 monoclonal antibody, has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia. This approval includes toripalimab in combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC), and as a single agent for recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Clinical Trial Data
The approval is based on data from the JUPITER-02 and POLARIS-02 clinical trials. The JUPITER-02 study, a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center trial, demonstrated a statistically significant improvement in overall survival (OS) when toripalimab was combined with chemotherapy, compared to chemotherapy alone. The study, which was presented at the 2021 ASCO meeting and published in Nature Medicine and JAMA, showed a 48% reduction in the risk of disease progression and a 37% reduction in the risk of death. The median progression-free survival (PFS) was extended by 13.2 months, from 8.2 months with chemotherapy alone to 21.4 months with the toripalimab combination. The five-year survival rate was 52% with the combined therapy.
The POLARIS-02 study, a multi-center, open-label, pivotal Phase 2 clinical study, evaluated toripalimab in patients with recurrent or metastatic NPC who had failed prior chemotherapy. The results, published in the Journal of Clinical Oncology, showed an objective response rate (ORR) of 20.5%, a duration of response (DoR) of 12.8 months, and a median OS of 17.4 months, demonstrating durable antitumor activity and a manageable safety profile.
Significance of Approval
Nasopharyngeal carcinoma (NPC) is a malignant tumor arising from the epithelium of the nasopharynx, with over 120,000 new cases diagnosed worldwide in 2022, according to GLOBOCAN statistics. Toripalimab is now the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers.
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, stated, "Toripalimab has made significant strides in its internationalization... This recent approval in Australia is not only extremely meaningful to the nasopharyngeal carcinoma patients there, but it also represents our company’s continued efforts toward globalization."
M.V. Ramana, CEO of Branded Markets, Dr. Reddy’s, added, "This approval is a significant milestone in our collaborative efforts with Junshi Biosciences to make their novel treatment available to patients around the world. Toripalimab is the first and only immuno-onocology treatment for nasopharyngeal carcinoma in Australia, and meets a significant unmet need for patients."
Regulatory Context
The New Chemical Entity (NCE) application for toripalimab was submitted under Project Orbis, an initiative by the FDA's Oncology Center of Excellence (OCE) to facilitate collaborative reviews of oncology drug applications among international regulatory authorities. The TGA also granted an orphan drug designation to toripalimab for the treatment of NPC, expediting the review process.
