FDA Approves Toripalimab for Nasopharyngeal Carcinoma

By: Dr. Anish Shah 

Bronx-Lebanon Hospital; Bronx, NY

On October 27, the U.S. Food and Drug Administration approved toripalimab-tpzi (Loqtorzi) in combination with chemotherapy for adult patients with metastatic or locally advanced nasopharyngeal carcinoma (NPC), as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy.

Study ID number: NCT03581786 and NCT02915432

Approval was based on phase 3 JUPITER-02 trial and phase 2 POLARIS-02 trial that included patients with NPC. Toripalimab in combination with cisplatin and gemcitabine was administered at a recommended dose of 240 mg every 3 weeks for up to 24 months or until unacceptable toxicity or disease progression. Likewise, the single agent toripalimab was given in previously treated patients at 3 mg/kg every 2 weeks. The median treatment duration was not specified.

Efficacy was established on progression-free survival (PFS) and overall survival (OS). The JUPITER-02 study yielded a 48% reduction in the risk of disease progression or death with respect to PFS and a 37% reduction in the risk of death with respect to OS among patients receiving the experimental regimen.  Results of POLARIS -02 study also showed that patients with recurrent or metastatic NPC experienced an objective response rate (ORR) of 20.5%, a disease control rate of 40.0%, and a median OS of 17.4 months when treated with toripalimab.

Toripalimab has demonstrated the ability to significantly improve PFS and OS and should quickly emerge as the new standard of care when used in combination with chemotherapy.  Side effects of the medication included grade 3 or higher adverse effects (AEs) in 89.7% of patients receiving toripalimab plus chemotherapy, AEs leading to treatment discontinuation in 11.6% of patients, and any grade immune-related AEs (IRAEs) in 54.1% of patients. High-grade AEs occurred in 9.6% of patients.