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Oncology News Central (ONC)FDA Approves Toripalimab Plus Chemo for Nasopharyngeal Carcinoma

Toripalimab Emerges as a New Standard of Care in Nasopharyngeal Carcinoma Treatment

The US Food and Drug Administration (FDA) has recently approved the use of toripalimab (Loqtorzi) in combination with chemotherapy as a first-line treatment for adults with advanced or recurrent nasopharyngeal carcinoma (NPC). This approval is based on data from the JUPITER-02 clinical trial and the POLARIS-02 clinical study.

Key Points

  • The FDA approved toripalimab plus chemotherapy for adults with advanced or recurrent NPC and as monotherapy for recurrent, unresectable, or metastatic NPC with disease progression either while receiving or after receiving platinum-based chemotherapy.
  • The approval was based on data from the randomized, double-blind, placebo-controlled, international multicenter phase 3 JUPITER-02 clinical trial and the single-arm, phase 2 POLARIS-02 clinical study.
  • Patients who received toripalimab after chemotherapy had a median progression-free survival (PFS) of 11.7 months compared with 8.0 months among participants treated with chemotherapy alone.
  • Updated figures showed that toripalimab elicited a 37% reduction in death compared with chemotherapy alone.
  • The POLARIS-02 trial showed that toripalimab elicited an overall response rate (ORR) of 20.5%, with a median duration of response of 12.8 months.

According to the American Cancer Society, nasopharyngeal carcinoma is relatively rare in the United States, with an estimated 0.25 cases per 100,000 people per year.

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