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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
Open accessAbstract
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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Metadata
- Authors
- Chow, L. Q. M., Haddad, R., Gupta, S., Mahipal, A., Mehra, R., Tahara, M., Berger, R., Eder, J. P., Burtness, B., Lee, S.-H., Keam, B., Kang, H., Muro, K., Weiss, J., Geva, R., Lin, C.-C., Chung, H. C., Meister, A., Dolled-Filhart, M., Pathiraja, K., Cheng, J. D., & Seiwert, T. Y.
- Venue
- Journal of Clinical Oncology
- Published
- 2016-11-10
- Volume
- 34
- Issue
- 32
- Pages
- 3838-3845
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2523194272
- Cited by
- 857
- References
- 10
- FWCI
- 56.87
- Type
- journal article
- Language
- en
- Open access
- green
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- Chow, L. Q. M., Haddad, R., Gupta, S., Mahipal, A., Mehra, R., Tahara, M., Berger, R., Eder, J. P., Burtness, B., Lee, S.-H., Keam, B., Kang, H., Muro, K., Weiss, J., Geva, R., Lin, C.-C., Chung, H. C., Meister, A., Dolled-Filhart, M., . . . Seiwert, T. Y. (2016). 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. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.68.1478
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