JUPITER-02: toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma
Adding the PD-1 antibody toripalimab to gemcitabine and cisplatin lengthened the time before metastatic nasopharyngeal cancer progressed by about four months, and later improved survival, making chemo-immunotherapy the first-line standard.
Overview
International randomised double-blind placebo-controlled phase 3 trial of 289 patients with recurrent or metastatic nasopharyngeal carcinoma assigned to toripalimab or placebo with gemcitabine and cisplatin, followed by toripalimab or placebo maintenance.
Median progression-free survival was 11.7 months with toripalimab against 8.0 months (hazard ratio 0.52) at the interim analysis, with benefit regardless of PD-L1 expression; the final analysis (JAMA 2023) showed improved overall survival. Toripalimab was approved in China in 2021 and by the FDA in 2024.
- Median progression-free survival 11.7 months with toripalimab plus chemotherapy versus 8.0 months with chemotherapy alone; hazard ratio 0.52.
- Benefit irrespective of PD-L1 status; overall survival improved at final analysis.
PD-1 blockade with gemcitabine and cisplatin is the first-line standard for recurrent or metastatic nasopharyngeal carcinoma, and the first immunotherapy approved for this cancer in the United States.
- Conducted in mainland China, Taiwan and Singapore; almost all patients had EBV-related non-keratinising disease.
- Immune-related adverse events, including hypothyroidism, were more frequent.
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