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

Open access
Harrington, Kevin J., Burtness, Barbara, Greil, Richard, Soulières, Denis, Tahara, Makoto, de Castro, Gilberto, Psyrri, Amanda, Brana, Irene, Basté, Neus, Neupane, Prakash, Bratland, Åse, Fuereder, Thorsten, Hughes, Brett G.M., Mesia, Ricard, Ngamphaiboon, Nuttapong, Rordorf, Tamara, Wan Ishak, Wan Zamaniah, Lin, Jianxin, Gumuscu, Burak, Swaby, Ramona F., Rischin, Danny·2023·Journal of Clinical Oncology

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.

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Metadata

Authors
Harrington, K. J., Burtness, B., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Brana, I., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesia, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Lin, J., Gumuscu, B., Swaby, R. F., & Rischin, D.
Venue
Journal of Clinical Oncology
Published
2023-02-01
Volume
41
Issue
4
Pages
790-802
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W4304474516
Cited by
522
References
15
FWCI
78.92
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. https://app.cochat.ai/papers/10.1200/jco.21.02508
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Harrington, K. J., Burtness, B., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Brana, I., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesia, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Lin, J., Gumuscu, B., . . . Rischin, D. (2023). Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.02508

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.