JUPITER-02

NCT03581786 📎

Regimen

Experimental
Toripalimab 240 mg IV q3w + gemcitabine/cisplatin (GP) ×6 cycles, followed by toripalimab maintenance until progression or 2 years
Control
Placebo IV q3w + gemcitabine/cisplatin (GP) ×6 cycles, followed by placebo maintenance

Population

Treatment-naive recurrent or metastatic NPC (95% of patients enrolled from Chinese mainland, Hong Kong, Taiwan, and Singapore); ECOG PS 0–1

Key finding

JUPITER-02 was the first positive phase 3 trial of chemo-IO combination versus chemo-alone in first-line recurrent/metastatic NPC worldwide. Toripalimab (Shanghai Junshi domestic Chinese anti-PD-1) plus GP produced both PFS and OS benefit. The trial led to FDA and NMPA approval of toripalimab + GP. Interim data were published in Nat Med 2021 (PMID: 34341578); final OS data in JAMA 2023 (PMID: 38015220).

Source: PMID 38015220

Timeline

    Guideline citations

    • NCCN NPC (p.42)