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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: | Burtness, Barbara Rischin, Danny Greil, Richard Soulières, Denis Tahara, Makoto Castro, Gilberto de Psyrri, Amanda Braña, Irene Basté, Neus Neupane, Prakash Bratland, Åse Fuereder, Thorsten Hughes, Brett G.M. Mesía Nin, Ricard Ngamphaiboon, Nuttapong Rordorf, Tamara Ishak, Wan Zamaniah Wan Ge, Joy Swaby, Ramona F. Gumuscu, Burak Harrington, Kevin J. |
Keywords: | Càncer de cap Càncer de coll Quimioteràpia Anticossos monoclonals Head cancer Neck cancer Chemotherapy Monoclonal antibodies |
Issue Date: | 20-Jul-2022 |
Publisher: | American Society of Clinical Oncology |
Abstract: | Purpose: The 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. Methods: Participants 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. Results: Of 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]). Conclusion: Increased 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1200/JCO.21.02198 |
It is part of: | Journal of Clinical Oncology, 2022, vol. 40, num. 21, p. 2321-2332 |
URI: | http://hdl.handle.net/2445/195683 |
Related resource: | https://doi.org/10.1200/JCO.21.02198 |
ISSN: | 0732-183X |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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