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J Clin Oncol. 2016 Nov 10;34(32):3838-3845. doi: 10.1200/JCO.2016.68.1478. Epub 2016 Sep 30.

Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort.

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Laura Q.M. Chow, University of Washington, Seattle Cancer Care Alliance, Seattle, WA; Robert Haddad, Dana-Farber Cancer Institute, Boston, MA; Shilpa Gupta and Amit Mahipal, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Ranee Mehra, Fox Chase Cancer Center, Philadelphia, PA; Joseph Paul Eder and Barbara Burtness, Yale University Cancer Center, New Haven, CT; Hyunseok Kang, Johns Hopkins University, Baltimore, MD; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Amy Meister, Marisa Dolled-Filhart, Kumudu Pathiraja, and Jonathan D. Cheng, Merck, Kenilworth, NJ; Tanguy Y. Seiwert, The University of Chicago, Chicago, IL; Makoto Tahara, National Cancer Center Hospital East, Kashiwa; Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan; Raanan Berger, Sheba Medical Center, Tel Hashomer; Ravit Geva, Sourasky Medical Center, Tel-Aviv, Israel; Se-Hoon Lee and Bhumsuk Keam, Seoul National University Hospital; Hyun Cheol Chung, Yonsei University College of Medicine, Seoul, Korea; and Chia-Chi Lin, National Taiwan University Hospital, Taipei, Taiwan.


Purpose Treatment with pembrolizumab, an anti-programmed death-1 antibody, at 10 mg/kg administered once every 2 weeks, displayed durable antitumor activity in programmed death-ligand 1 (PD-L1) -positive recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) in the KEYNOTE-012 trial. Results from the expansion cohort, in which patients with HNSCC, irrespective of biomarker status, received a fixed dose of pembrolizumab at a less frequent dosing schedule, are reported. Patients and Methods Patients with R/M HNSCC, irrespective of PD-L1 or human papillomavirus status, received pembrolizumab 200 mg intravenously once every 3 weeks. Imaging was performed every 8 weeks. Primary end points were overall response rate (ORR) per central imaging vendor (Response Evaluation Criteria in Solid Tumors v1.1) and safety. Secondary end points included progression-free survival, overall survival, and association of response and PD-L1 expression. Patients who received one or more doses of pembrolizumab were included in analyses. Results Of 132 patients enrolled, median age was 60 years (range, 25 to 84 years), 83% were male, and 57% received two or more lines of therapy for R/M disease. ORR was 18% (95% CI, 12 to 26) by central imaging vendor and 20% (95% CI, 13 to 28) by investigator review. Median duration of response was not reached (range, ≥ 2 to ≥ 11 months). Six-month progression-free survival and overall survival rates were 23% and 59%, respectively. By using tumor and immune cells, a statistically significant increase in ORR was observed for PD-L1-positive versus -negative patients (22% v 4%; P = .021). Treatment-related adverse events of any grade and grade ≥ 3 events occurred in 62% and 9% of patients, respectively. Conclusion Fixed-dose pembrolizumab 200 mg administered once every 3 weeks was well tolerated and yielded a clinically meaningful ORR with evidence of durable responses, which supports further development of this regimen in patients with advanced HNSCC.


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