RATIONALE-309

NCT03924986 📎

Regimen

Experimental
Tislelizumab 200 mg IV q3w + gemcitabine/cisplatin (GP) q3w for 4–6 cycles, then tislelizumab maintenance
Control
Placebo IV q3w + gemcitabine/cisplatin (GP) q3w for 4–6 cycles, then placebo maintenance

Population

Treatment-naive recurrent or metastatic NPC (R/M NPC); ECOG PS 0–1; enrolled at multiple Chinese centers

Key finding

Tislelizumab (BeiGene 百济神州 domestic Chinese anti-PD-1) plus GP produced a near-identical PFS HR (0.52) to JUPITER-02 and CAPTAIN-1st, completing the extraordinary Chinese phase 3 triad. Three different domestic PD-1 antibodies, each added to GP, each hitting HR ~0.52 PFS improvement in the same RM NPC population. Gene expression profiling identified an activated dendritic cell signature associated with benefit.

Source: PMID 37207654

Timeline

    Guideline citations

    • NCCN NPC (p.42)