Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
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Background Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.Methods KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031.Findings Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45-0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64-0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71-1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63-0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45-0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53-0·80], p<0·0001) at final analysis. Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis. At final analysis, grade 3 or worse all-cause adverse events occurred in 164 (55%) of 300 treated participants in the pembrolizumab alone group, 235 (85%) of 276 in the pembrolizumab with chemotherapy group, and 239 (83%) of 287 in the cetuximab with chemotherapy group. Adverse events led to death in 25 (8%) participants in the pembrolizumab alone group, 32 (12%) in the pembrolizumab with chemotherapy group, and 28 (10%) in the cetuximab with chemotherapy group.Interpretation Based on the observed efficacy and safety, pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1-positive recurrent or metastatic HNSCC.Funding Merck Sharp & Dohme.
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Two fatal cases of myocarditis showed overexpression of cardiac proteins in the tumors of the affected patients.
“Another study of two fatal cases of myocarditis showed overexpression of cardiac proteins in the tumors of the affected patients, also potentially suggesting an overlap.18”
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- Authors
- Burtness, B., Harrington, K. J., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesía, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Hong, R.-L., González Mendoza, R., Roy, A., Zhang, Y., Gumuscu, B., Cheng, J. D., Jin, F., Rischin, D., Lerzo, G., Tatangelo, M., Varela, M., Zarba, J. J., Boyer, M., Gan, H., Gao, B., Hughes, B., Mallesara, G., Rischin, D., Taylor, A., Burian, M., Fuereder, T., Greil, R., Barrios, C. H., de Castro Junior, D. O., Castro, G., Franke, F. A., Girotto, G., Lima, I. P. F., Nicolau, U. R., Pinto, G. D. J., Santos, L., Victorino, A.-P., Chua, N., Couture, F., Gregg, R., Hansen, A., Hilton, J., McCarthy, J., Soulieres, D., Ascui, R., Gonzalez, P., Villanueva, L., Torregroza, M., Zambrano, A., Holeckova, P., Kral, Z., Melichar, B., Prausova, J., Vosmik, M., Andersen, M., Gyldenkerne, N., Jurgens, H., Putnik, K., Reinikainen, P., Gruenwald, V., Laban, S., Aravantinos, G., Boukovinas, I., Georgoulias, V., Psyrri, A., Kwong, D., Al-Farhat, Y., Csoszi, T., Erfan, J., Horvai, G., Landherr, L., Remenar, E., Ruzsa, A., Szota, J., Billan, S., Gluck, I., Gutfeld, O., Popovtzer, A., Benasso, M., Bui, S., Ferrari, V., Licitra, L., Nole, F., Fujii, T., Fujimoto, Y., Hanai, N., Hara, H., Matsumoto, K., Mitsugi, K., Monden, N., Nakayama, M., Okami, K., Oridate, N., Shiga, K., Shimizu, Y., Sugasawa, M., Tahara, M., Takahashi, M., Takahashi, S., Tanaka, K., Ueda, T., Yamaguchi, H., Yamazaki, T., Yasumatsu, R., Yokota, T., Yoshizaki, T., Kudaba, I., Stara, Z., Wan Ishak, W. Z., Cheah, S. K., Aguilar Ponce, J., Gonzalez Mendoza, R., Hernandez Hernandez, C., Medina Soto, F., Buter, J., Hoeben, A., Oosting, S., Suijkerbuijk, K., Bratland, A., Brydoey, M., Alvarez, R., Mas, L., Caguioa, P., Querol, J., Regala, E. E., Tamayo, M. B., Villegas, E. M., Kawecki, A., Karpenko, A., Klochikhin, A., Smolin, A., Zarubenkov, O., Goh, B. C., Cohen, G., du Toit, J., Jordaan, C., Landers, G., Ruff, P., Szpak, W., Tabane, N., Brana, I., Iglesias Docampo, L., Lavernia, J., Mesia, R., Abel, E., Muratidu, V., Nielsen, N., Cristina, V., Rordorf, T., Rothschild, S., Hong, R.-L., Wang, H.-M., Yang, M.-H., Yeh, S.-P., Yen, C.-J., Ngamphaiboon, N., Soparattanapaisarn, N., Sriuranpong, V., Aksoy, S., Cicin, I., Ekenel, M., Harputluoglu, H., Ozyilkan, O., Harrington, K., Agarwala, S., Ali, H., Alter, R., Anderson, D., Bruce, J., Burtness, B., Campbell, N., Conde, M., Deeken, J., Edenfield, W., Feldman, L., Gaughan, E., Goueli, B., Halmos, B., Hegde, U., Hunis, B., Jotte, R., Karnad, A., Khan, S., Laudi, N., Laux, D., Martincic, D., McCune, S., McGaughey, D., Misiukiewicz, K., Mulford, D., Nadler, E., Neupane, P., Nunnink, J., Ohr, J., O'Malley, M., Patson, B., Paul, D., Popa, E., Powell, S., Redman, R., Rella, V., Rocha Lima, C., Sivapiragasam, A., Su, Y., Sukari, A., Wong, S., Yilmaz, E., & Yorio, J.
- Affiliations
- Vall d'Hebron Hospital Universitari (ES)
- Oslo University Hospital (NO)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Mahidol University (TH)
- Paracelsus Medical University (AT)
- National Cancer Center Hospital East (JP)
- The University of Melbourne (AU)
- Autonomous University of Chihuahua (MX)
- ORCID
- Basté, Neus
- Bratland, Åse
- Roy, Ananya
- Jin, Fan
- Boyer, Michael
- Gan, Hui
- Gao, Bo
- Mallesara, Girish
- Burian, Martin
- Barrios, Carlos Henrique
- Franke, Fabio Andre
- Girotto, Gustavo
- Nicolau, Ulisses Ribaldo
- Pinto, Gustavo Dix Junqueira
- Santos, Lucas
- Victorino, Ana-Paula
- Chua, Neil
- Gregg, Richard
- Hansen, Aaron
- Hilton, John
- Zambrano, Angela
- Melichar, Bohuslav
- Andersen, Maria
- Reinikainen, Petri
- Laban, Simon
- Aravantinos, Gerasimos
- Boukovinas, Ioannis
- Billan, Salem
- Popovtzer, Aron
- Bui, Simona
- Licitra, Lisa
- Fujii, Takashi
- Fujimoto, Yasushi
- Hanai, Nobuhiro
- Hara, Hiroki
- Matsumoto, Koji
- Monden, Nobuya
- Nakayama, Masahiro
- Okami, Kenji
- Oridate, Nobuhiko
- Shiga, Kiyoto
- Shimizu, Yasushi
- Sugasawa, Masashi
- Takahashi, Masanobu
- Takahashi, Shunji
- Tanaka, Kaoru
- Ueda, Tsutomu
- Yamaguchi, Hironori
- Yamazaki, Tomoko
- Yasumatsu, Ryuji
- Yokota, Tomoya
- Yoshizaki, Tomokazu
- Buter, Jan
- Hoeben, Ann
- Oosting, S.
- Suijkerbuijk, Karijn
- Mas, Luis
- Caguioa, Priscilla
- Kawecki, Andrzej
- Klochikhin, Arkadiy
- Smolin, Alexey
- Goh, Boon Cher
- Cohen, Graham
- Ruff, Paul
- Szpak, Waldemar
- Lavernia, Javier
- Abel, Edvard
- Rothschild, Sacha
- Wang, Hung-Ming
- Yang, Muh-Hwa
- Yeh, Su-Peng
- Yen, Chia-Jui
- Sriuranpong, Virote
- Aksoy, Sercan
- Ekenel, Meltem
- Agarwala, Sanjiv
- Ali, Haythem
- Alter, Robert
- Anderson, Daniel
- Bruce, Justine
- Campbell, Nicholas
- Conde, Miguel
- Deeken, John
- Feldman, Lawrence
- Gaughan, Elizabeth
- Hegde, Upendra
- Jotte, Robert
- Karnad, Anand
- Khan, Saad
- Laudi, Noel
- Laux, Douglas
- McCune, Steven
- Misiukiewicz, Krzysztof
- Nadler, Eric
- Ohr, James
- Paul, Doru
- Powell, Steven
- Sivapiragasam, Abirami
- Sukari, Ammar
- Wong, Stuart
- Yilmaz, Emrullah
- Yorio, Jeffrey
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2019-11
- Volume
- 394
- Issue
- 10212
- Pages
- 1915-1928
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2986633517
- Cited by
- 3,336
- References
- 25
- Citations by year
- 2026: 434 · 2025: 551 · 2024: 549 · 2023: 522 · 2022: 535 · 2021: 465 · 2020: 270 · 2019: 5 · 2013: 1
- FWCI
- 268.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- IRIS (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Regeneron Pharmaceuticals
- National Institute for Health and Care Research (NF-SI-0515-10101)
- Eisai
- Japan Society for the Promotion of Science (17H01590, 17K19718)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Keywords
- cetuximab, head and neck squamous cell carcinoma, recurrent or metastatic cancer, PD-L1 expression, PD-L1 combined positive score, immune checkpoint inhibitors, overall survival, progression-free survival, non-inferiority, p16 status, treatment safety
- MeSH terms
- Cetuximab, Antineoplastic Agents, Immunological, Squamous Cell Carcinoma of Head and Neck, Progression-Free Survival, Aged, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Female, Fluorouracil, Head and Neck Neoplasms, Humans, Male, Middle Aged, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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