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Clinical Trial
. 2018 Jul;119(2):153-159.
doi: 10.1038/s41416-018-0131-9. Epub 2018 Jun 29.

Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012

Ranee Mehra  1   2 , Tanguy Y Seiwert  3 , Shilpa Gupta  4   5 , Jared Weiss  6 , Iris Gluck  7 , Joseph P Eder  8 , Barbara Burtness  9   8 , Makoto Tahara  10 , Bhumsuk Keam  11 , Hyunseok Kang  12 , Kei Muro  13 , Ravit Geva  14 , Hyun Cheol Chung  15 , Chia-Chi Lin  16 , Deepti Aurora-Garg  17 , Archana Ray  17 , Kumudu Pathiraja  17 , Jonathan Cheng  17 , Laura Q M Chow  18 , Robert Haddad  19
Affiliations
Clinical Trial

Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012

Ranee Mehra et al. Br J Cancer. 2018 Jul.

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.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Tumour response to pembrolizumab according to RECIST v1.1 by central imaging vendor review. a Best percentage change from baseline in target lesions (n = 139). Includes patients who had measurable disease at baseline and at least one post baseline scan. b Treatment exposure and duration of response in patients achieving partial responses or complete responses (n = 34). c Kaplan–Meier estimate of the duration of response in patients achieving partial responses or complete responses. RECIST Response Evaluation Criteria in Solid Tumors
Fig. 3
Fig. 3
Survival in patients treated with pembrolizumab. Kaplan–Meier estimates of a progression-free survival per RECIST v1.1 by central imaging vendor review and b overall survival (all-patients-as-treated population). RECIST Response Evaluation Criteria in Solid Tumors
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