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Mehra R , Seiwert TY , Gupta S , Weiss J , Gluck I , Eder JP , Burtness B , Tahara M , Keam B , Kang H , Muro K , Geva R , Chung HC , Lin CC , Aurora-Garg D , Ray A , Pathiraja K , Cheng J , Chow LQM , Haddad R
Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012
Br J Cancer. 2018 Jul;119(2) :153-159
PMID: 29955135    PMCID: PMC6048158   
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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.
1532-1827 Mehra, Ranee Seiwert, Tanguy Y Gupta, Shilpa Weiss, Jared Gluck, Iris Eder, Joseph P Burtness, Barbara Tahara, Makoto Keam, Bhumsuk Kang, Hyunseok Muro, Kei Geva, Ravit Chung, Hyun Cheol Lin, Chia-Chi Aurora-Garg, Deepti Ray, Archana Pathiraja, Kumudu Cheng, Jonathan Chow, Laura Q M Haddad, Robert Clinical Trial, Phase I Journal Article Multicenter Study England Br J Cancer. 2018 Jul;119(2):153-159. doi: 10.1038/s41416-018-0131-9. Epub 2018 Jun 29.