KEYNOTE-A18 — Pembrolizumab plus Chemoradiotherapy vs Placebo plus Chemoradiotherapy for High-Risk Locally Advanced Cervical Cancer

Phase 3 · 2024 · Cervical Cancer

Design

Randomized, double-blind, placebo-controlled: pembrolizumab (200 mg every 3 weeks for 5 cycles concurrent with chemoradiotherapy, then 400 mg every 6 weeks for up to 15 cycles) plus concurrent chemoradiotherapy (cisplatin, external-beam radiotherapy, and brachytherapy) versus placebo plus the same chemoradiotherapy.

Population

Newly diagnosed, high-risk locally advanced cervical cancer (FIGO 2014 stage IB2-IIB with node-positive disease, or stage III-IVA regardless of nodal status).

Primary Endpoint

progression-free survival and overall survival

Key Result

PFS significantly improved (HR 0.70; 95% CI 0.55-0.89); OS HR 0.73 (95% CI 0.49-1.07) with 24-month OS 87% vs 81% favoring pembrolizumab.

Guideline Impact

FDA approval January 2024 for FIGO 2014 stage III-IVA cervical cancer with chemoradiotherapy; NCCN-endorsed