Long-term results of the randomized, phase 3 KEYNOTE-412 trial of pembrolizumab (pembro) or placebo (pbo) plus concurrent chemoradiotherapy (CRT) for unresected, locally advanced head and neck squamous cell carcinoma (LA HNSCC).

作者：Yungan Tao, Lillian L. Siu, Lisa Licitra, Barbara Burtness, Makoto Tahara, Danny Rischin, Gustavo Vasconcelos Alves, Iane Pinto Figueiredo Lima, Brett Hughes, Y. Pointreau, Sercan Aksoy, Simon Laban, Richard Greil, Martin Burian, Marcin Hetnał, Jean‐Pierre Delord, Laurent Kassalow, Behzad Bidadi, Burak Gümüşçü, Jean‐Pascal Machiels · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.6013 · 被引用次数：13 · 研究领域：Head and Neck Cancer Studies、Lung Cancer Research Studies、Lung Cancer Treatments and Mutations

6013 Background: In the final efficacy analysis of the randomized, double-blind, phase 3 KEYNOTE-412 trial (NCT03040999), pembro + CRT did not significantly improve event-free survival (EFS) vs pbo + CRT (HR 0.83; 95% CI 0.68-1.03) in unresected LA HNSCC. We present results for KEYNOTE-412 with >2 yrs of additional follow-up. Methods: Adults with newly diagnosed high-risk unresected LA HNSCC (any T3-T4 [N0-N3] or any N2a-3 [T1-T4] larynx/hypopharynx/oral cavity/p16-negative oropharynx cancers and T4 or N3 p16-positive oropharynx cancer) were randomly assigned to receive CRT (70 Gy in 35 fractions + 3 cycles cisplatin 100 mg/m 2 Q3W) + 17 cycles of pembro 200 mg or pbo IV Q3W: first cycle 1 week prior to CRT, 2 cycles during CRT, then 14 cycles of maintenance. The primary end point was EFS assessed by blinded independent central review. The key secondary end point was overall survival (OS). Efficacy was analyzed in all randomly assigned pts (ITT population). Exploratory analyses included locoregional control (LRC), distant metastasis-free survival (DMFS), incidence of second malignancies in the ITT population, and efficacy in pts with PD-L1 CPS ≥1. Results: 402 pts were assigned to each arm; and 398 received ≥1 dose of study treatment in each arm. As of data cutoff date (August 21, 2024), median study follow-up was 74.4 mo (range, 63.7-88.1). EFS was longer with pembro vs pbo (HR 0.79; 95% CI 0.65-0.96). Overall, 186 (46.3%) and 217 (54.0%) EFS events occurred in the pembro...