@article{f8f3f755ab6d438aad0dfeae27945da9,
title = "Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: Pooled analyses after long-term follow-up in KEYNOTE-012",
abstract = "Background: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Methods: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Results: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. Conclusions: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.",
author = "Ranee Mehra and Seiwert, {Tanguy Y.} and Shilpa Gupta and Jared Weiss and Iris Gluck and Eder, {Joseph P.} and Barbara Burtness and Makoto Tahara and Bhumsuk Keam and Hyunseok Kang and Kei Muro and Ravit Geva and Chung, {Hyun Cheol} and Lin, {Chia Chi} and Deepti Aurora-Garg and Archana Ray and Kumudu Pathiraja and Jonathan Cheng and Chow, {Laura Q.M.} and Robert Haddad",
note = "Funding Information: We thank the patients and their families, and caregivers for participating in the study. We also thank Jennifer Yearley of Merck & Co., Inc., Kenilworth, NJ, USA, for her contributions to this research. Medical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, Dana Francis, PhD, and the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA. Funding Information: The study was designed and funded by Merck & Co., Inc., Kenilworth, NJ, USA. R.M., T. Y.S., J.W., I.G., J.P.E., B.B., M.T., B.K., H.K., M.K., H.C.C., C.C.L., A.R., K.P., L.Q.W., and R.H. collected the data. R.M., J.W., B.B., H.C.C., D.A.-G., K.P., J.C., L.Q.W., and R.H. analyzed the data. R.M., T.Y.S., J.W., I.G., B.B., M.T., B.K., H.K., H.C.C., C.C.L., K.P., J.C., L.Q.W., and R. H. contributed to the interpretation of the results. R.M., M.T., and K.P. contributed to drafting of the manuscript. Funding Information: Competing interests: T.Y.S., J.W., B.B., and H.K. have received research funding from Merck & Co., Inc. M.T. has received personal fees from Merck Sharp & Dohme. D.A.-G., A.R., K.P., and J.C. are employees Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. L.Q.C. has served as an advisor for and has received research from Merck & Co., Inc. R.H. has received research funding from Merck & Co., Inc., Bristol-Myers Squibb, Pfizer, and Astra Zeneca, and has served as a consultant for Merck & Co., Inc., Bristol-Myers Squibb, Pfizer, Celgene, Astra Zeneca, and Eisai. The remaining authors declare no competing interests. Publisher Copyright: {\textcopyright} 2018 The Author(s).",
year = "2018",
month = jul,
day = "17",
doi = "10.1038/s41416-018-0131-9",
language = "English (US)",
volume = "119",
pages = "153--159",
journal = "British journal of cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
number = "2",
}