Dr Hanna on the FDA Approval of Toripalimab in Nasopharyngeal Carcinoma

Glenn J. Hanna, MD, director, Center for Cancer Therapeutic Innovation (Early Drug Development Program), director, Center for Salivary and Rare Head and Neck Cancers, physician, Dana-Farber Cancer Institute; assistant professor, medicine, Harvard Medical School, discusses the significance of the FDA approval of toripalimab-tpzi (Loqtorzi) for patients with recurrent or metastatic nasopharyngeal carcinoma.

On October 27, 2023, the FDA approved the combination of toripalimab, cisplatin, and gemcitabine for the treatment of adult patients with metastatic or locally recurrent nasopharyngeal carcinoma that has progressed on or after platinum-containing chemotherapy, irrespective of PD-L1 status. The agent also gained approval as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed on or after treatment with platinum-based chemotherapy.

This regulatory decision was backed by findings from the phase 3 JUPITER-02 (NCT03581786) and phase 2 POLARIS-02 (NCT02915432) trials. In JUPITER-02, the combination led to a 48% reduction in the risk of disease progression or death vs chemotherapy alone (HR = 0.52; 95% CI, 0.36-0.74; P < .0003), as well as a 37% reduction in the risk of death compared with chemotherapy alone. In POLARIS-02, toripalimab generated an overall response rate of 20.5%, a disease control rate of 40.0%, and a median overall survival of 17.4 months.

Viral-associated nasopharyngeal carcinoma, including Epstein-Barr virus (EBV)–associated disease, is not as common in Western countries as it is in Asia and northern Africa. This is likely because of the epidemiology of the EBV virus, Hanna says. Prior to this approval, little data existed to guide treatment decisions for patients with nasopharyngeal carcinoma in the United States, as most clinical trials in this population were conducted in Asia, Hanna explains.

The JUPITER-02 regimen combined toripalimab, an immunotherapy agent, with the standard gemcitabine/cisplatin backbone for patients with advanced disease, Hanna notes. This combination improves responses, survival outcomes, and time to progression in this patient population, Hanna emphasizes. Chemoimmunotherapy regimens have proven effective in other cancer types, such as head and neck squamous cell carcinomas excluding nasopharyngeal carcinoma, according to Hanna. This FDA approval demonstrates the benefits of such combinations in patients with this unique subtype of head and neck cancer, Hanna concludes.