Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study
Details
Publication Year 2023,Volume 41,Issue #4,Page 790-802
Journal Title
Journal of Clinical Oncology
Publication Type
Research article
Abstract
PURPOSE: Pembrolizumab 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. METHODS: Patients 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. RESULTS: The median study follow-up was 45.0 months (interquartile range, 41.0-49.2; n = 882). At data cutoff (February 18, 2020), overall survival improved with pembrolizumab in the PD-L1 CPS >/= 20 (hazard ratio [HR], 0.61; 95% CI, 0.46 to 0.81) and CPS >/= 1 populations (HR, 0.74; 95% CI, 0.61 to 0.89) and was noninferior in the total population (HR, 0.81; 95% CI, 0.68 to 0.97). Overall survival improved with pembrolizumab-chemotherapy in the PD-L1 CPS >/= 20 (HR, 0.62; 95% CI, 0.46 to 0.84), CPS >/= 1 (HR, 0.64; 95% CI, 0.53 to 0.78), and total (HR, 0.71; 95% CI, 0.59 to 0.85) populations. The objective response rate on second-course pembrolizumab was 27.3% (3 of 11). PFS2 improved with pembrolizumab in the PD-L1 CPS >/= 20 (HR, 0.64; 95% CI, 0.48 to 0.84) and CPS >/= 1 (HR, 0.79; 95% CI, 0.66 to 0.95) populations and with pembrolizumab-chemotherapy in the PD-L1 CPS >/= 20 (HR, 0.64; 95% CI, 0.48 to 0.86), CPS >/= 1 (HR, 0.66; 95% CI, 0.55 to 0.81), and total (HR, 0.73; 95% CI, 0.61 to 0.88) populations. PFS2 was similar after pembrolizumab and longer after pembrolizumab-chemotherapy on next-line taxanes and shorter after pembrolizumab and similar after pembrolizumab-chemotherapy on next-line nontaxanes. CONCLUSION: With a 4-year follow-up, first-line pembrolizumab and pembrolizumab-chemotherapy continued to demonstrate survival benefit versus cetuximab-chemotherapy in recurrent/metastatic head and neck squamous cell carcinoma. Patients responded well to subsequent treatment after pembrolizumab-based therapy.
Publisher
American Society of Clinical Oncology
Keywords
Humans; Squamous Cell Carcinoma of Head and Neck/drug therapy; Cetuximab/therapeutic use; *B7-H1 Antigen/metabolism; Neoplasm Recurrence, Local/drug therapy/etiology; *Head and Neck Neoplasms/drug therapy; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Department(s)
Medical Oncology
PubMed ID
36219809
Open Access at Publisher's Site
https://doi.org/10.1200/JCO.21.02508
Terms of Use/Rights Notice
Refer to copyright notice on published article.


Creation Date: 2023-05-30 07:27:44
Last Modified: 2023-05-30 07:28:52

© 2024 The Walter and Eliza Hall Institute of Medical Research. Access to this website is subject to our Privacy Policy and Terms of Use

An error has occurred. This application may no longer respond until reloaded. Reload 🗙