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Pembrolizumab + gemcitabine + cisplatin (KEYNOTE-966) — 1L advanced biliary tract cancer

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.

Source YAML: dossier complet

ComposantesDRUG-PEMBROLIZUMAB DRUG-GEMCITABINE DRUG-CISPLATIN
IDREG-PEMBRO-GEM-CIS-CHOLANGIO
TypeProtocole thérapeutique
Étatreviewed 2026-05-08 | pending_clinical_signoff
MaladiesAucune déclaration
SourcesSRC-ESMO-BTC-2023 SRC-KEYNOTE-966-KELLEY-2023 SRC-NCCN-HEPATOBILIARY

Notes

KEYNOTE-966 (Kelley RK et al., Lancet 2023;401(10391):1853-1865; NCT04003636): pembrolizumab 200 mg q3w + gemcitabine 1000 mg/m² + cisplatin 25 mg/m² (D1, D8 q3w; cisplatin capped at 8 cycles, gem continued indefinitely with pembro), vs placebo + gem-cis in 1L advanced BTC (n=1069). Primary endpoint OS: mOS 12.7 vs 10.9 mo (HR 0.83, 95% CI 0.72-0.95, p=0.0034); mPFS 6.5 vs 5.6 mo (HR 0.86, ns); ORR 29% vs 29% (no improvement). Benefit consistent across PD-L1 CPS subgroups; magnitude smaller than TOPAZ-1 but corroborates anti-PD-(L)1 + chemo as new 1L standard. FDA-approved Oct 2023. NCCN category 1 alternative preferred regimen alongside TOPAZ-1. Note: KEYNOTE-966 differs from TOPAZ-1 in that gemcitabine continues past 8 cycles as maintenance with pembrolizumab (cisplatin capped at cycle 8); TOPAZ-1 stops both gem and cis at cycle 8 with durvalumab monotherapy maintenance. STUB pending Clinical Co-Lead sign-off per CHARTER §6.1 dev-mode exemption.

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