Pembrolizumab Alone or with Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score
Issued Date
2022-01-01
Resource Type
ISSN
0732183X
eISSN
15277755
Scopus ID
2-s2.0-85130901163
Pubmed ID
35333599
Journal Title
Journal of Clinical Oncology
Volume
40
Issue
21
Start Page
2321
End Page
2332
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Clinical Oncology Vol.40 No.21 (2022) , 2321-2332
Suggested Citation
Burtness B., Rischin D., 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., Ge J., Swaby R.F., Gumuscu B., Harrington K. Pembrolizumab Alone or with Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. Journal of Clinical Oncology Vol.40 No.21 (2022) , 2321-2332. 2332. doi:10.1200/JCO.21.02198 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/83909
Title
Pembrolizumab Alone or with Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score
Author's Affiliation
Ramathibodi Hospital
Vall d‘Hebron Institut de Oncologia
Oslo Universitetssykehus
Peter Maccallum Cancer Centre
Universiti Malaya
National and Kapodistrian University of Athens
Royal Brisbane and Women's Hospital
UniversitatsSpital Zurich
Yale School of Medicine
The Royal Marsden NHS Foundation Trust
Institute Catala Oncologia
Paracelsus Medizinische Privatuniversitat
Medizinische Universität Wien
National Cancer Center Hospital East
Centre Hospitalier de L'Universite de Montreal
Universidade de São Paulo
Merck & Co., Inc.
University of Kansas Medical Center
Vall d‘Hebron Institut de Oncologia
Oslo Universitetssykehus
Peter Maccallum Cancer Centre
Universiti Malaya
National and Kapodistrian University of Athens
Royal Brisbane and Women's Hospital
UniversitatsSpital Zurich
Yale School of Medicine
The Royal Marsden NHS Foundation Trust
Institute Catala Oncologia
Paracelsus Medizinische Privatuniversitat
Medizinische Universität Wien
National Cancer Center Hospital East
Centre Hospitalier de L'Universite de Montreal
Universidade de São Paulo
Merck & Co., Inc.
University of Kansas Medical Center
Other Contributor(s)
Abstract
PURPOSEThe phase III KEYNOTE-048 (ClinicalTrials.gov identifier: NCT02358031) trial of pembrolizumab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) included planned efficacy analyses in the total population and in participants with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 1 and CPS ≥ 20. To further characterize the predictive value of PD-L1 expression on outcome, we conducted efficacy analyses in the PD-L1 CPS < 1 and CPS 1-19 subgroups in KEYNOTE-048.METHODSParticipants with R/M HNSCC and no prior systemic therapy for R/M disease were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Post hoc efficacy analyses of the PD-L1 CPS < 1 and CPS 1-19 subgroups were performed.RESULTSOf 882 participants enrolled, 128 had PD-L1 CPS < 1 and 373 had CPS 1-19. For pembrolizumab versus cetuximab-chemotherapy, the median overall survival was 7.9 versus 11.3 months in the PD-L1 CPS < 1 subgroup (hazard ratio [HR], 1.51 [95% CI, 0.96 to 2.37]) and 10.8 versus 10.1 months in the CPS 1-19 subgroup (HR, 0.86 [95% CI, 0.66 to 1.12]). For pembrolizumab-chemotherapy versus cetuximab-chemotherapy, the median overall survival was 11.3 versus 10.7 months in the PD-L1 CPS < 1 subgroup (HR, 1.21 [95% CI, 0.76 to 1.94]) and 12.7 versus 9.9 months in the CPS 1-19 subgroup (HR, 0.71 [95% CI, 0.54 to 0.94]).CONCLUSIONIncreased efficacy of pembrolizumab or pembrolizumab-chemotherapy was observed with increasing PD-L1 expression. PD-L1 CPS < 1 subgroup analysis was limited by small participant numbers. Results from the PD-L1 CPS 1-19 subgroup support previous findings of treatment benefit with pembrolizumab monotherapy and pembrolizumab-chemotherapy in patients with PD-L1 CPS ≥ 1 tumors. Although PD-L1 expression is informative, exploration of additional predictive biomarkers is needed for low PD-L1-expressing HNSCC.