dc.contributor.author | Burtness, B | |
dc.contributor.author | Rischin, D | |
dc.contributor.author | Greil, R | |
dc.contributor.author | Soulières, D | |
dc.contributor.author | Tahara, M | |
dc.contributor.author | de Castro, G | |
dc.contributor.author | Psyrri, A | |
dc.contributor.author | Brana, I | |
dc.contributor.author | Basté, N | |
dc.contributor.author | Neupane, P | |
dc.contributor.author | Bratland, Å | |
dc.contributor.author | Fuereder, T | |
dc.contributor.author | Hughes, BGM | |
dc.contributor.author | Mesia, R | |
dc.contributor.author | Ngamphaiboon, N | |
dc.contributor.author | Rordorf, T | |
dc.contributor.author | Wan Ishak, WZ | |
dc.contributor.author | Ge, J | |
dc.contributor.author | Swaby, RF | |
dc.contributor.author | Gumuscu, B | |
dc.contributor.author | Harrington, K | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-06T11:35:48Z | |
dc.date.available | 2022-09-06T11:35:48Z | |
dc.date.issued | 2022-07-20 | |
dc.identifier.citation | Journal of Clinical Oncology, 2022, 40 (21), pp. 2321 - 2332 | en_US |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5415 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.21.02198 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 2321 - 2332 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | en_US |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | B7-H1 Antigen | |
dc.subject | Cetuximab | |
dc.subject | Head and Neck Neoplasms | |
dc.subject | Humans | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Squamous Cell Carcinoma of Head and Neck | |
dc.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. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-07-01 | |
dc.date.updated | 2022-09-06T11:35:01Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1200/JCO.21.02198 | en_US |
rioxxterms.licenseref.startdate | 2022-07-20 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35333599 | |
pubs.issue | 21 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy | |
pubs.organisational-group | /ICR/ImmNet | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.21.02198 | |
pubs.volume | 40 | |
icr.researchteam | Targeted Therapy | en_US |
dc.contributor.icrauthor | Harrington, Kevin | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-06. Deposit type is initial. No. of files: 1. Files: Pembrolizumab Alone or With Chemotherapy for RecurrentMetastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048 Subgro.pdf | |