Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study

KJ Harrington; B Burtness; R Greil; D Soulières; M Tahara; G De Castro; A Psyrri; I Brana; N Basté; P Neupane; Å Bratland; T Fuereder; BGM Hughes; R Mesia; N Ngamphaiboon; T Rordorf; WZ Wan Ishak; J Lin; B Gumuscu; RF Swaby; D Rischin

Journal article

Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study

KJ Harrington, B Burtness, R Greil, D Soulières, M Tahara, G De Castro, A Psyrri, I Brana, N Basté, P Neupane, Å Bratland, T Fuereder, BGM Hughes, R Mesia, N Ngamphaiboon, T Rordorf, WZ Wan Ishak, J Lin, B Gumuscu, RF Swaby Show all

Journal of Clinical Oncology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2023

DOI: 10.1200/JCO.21.02508

Open access

Abstract

PURPOSEPembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048. Post hoc analysis of long-term efficacy and progression-free survival on next-line therapy (PFS2) is presented.METHODSPatients were randomly assigned (1:1:1) to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Efficacy was evaluated in programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, CPS ≥ 1, and total populations, with no multiplicity or alpha adjustment.RESULTSThe median study follow-up was 45.0 months (interquartile range, 41.0-49.2; n = 882). At data cutoff (February 18, 2020), overall survival im..

View full abstract