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

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.

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

Issued Date

2023-02-01

Resource Type

Article

ISSN

0732183X

eISSN

15277755

DOI

10.1200/JCO.21.02508

Scopus ID

2-s2.0-85147094382

Pubmed ID

36219809

Journal Title

Journal of Clinical Oncology

Volume

41

Issue

4

Start Page

790

End Page

802

Rights Holder(s)

SCOPUS

Bibliographic Citation

Journal of Clinical Oncology Vol.41 No.4 (2023) , 790-802

Suggested Citation

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. 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 Vol.41 No.4 (2023) , 790-802. 802. doi:10.1200/JCO.21.02508 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/81670

Title

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

Other Contributor(s)

Mahidol University

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 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.CONCLUSIONWith 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.

Keyword(s)

Biochemistry, Genetics and Molecular Biology

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/81670

Collections

Scopus 2023

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