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Br J Cancer. 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.

Author information

1
Fox Chase Cancer Center, Philadelphia, PA, USA. rmehra1@jhmi.edu.
2
Johns Hopkins University, Baltimore, MD, USA. rmehra1@jhmi.edu.
3
University of Chicago, Chicago, IL, USA.
4
H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.
5
Masonic Cancer Centre, University of Minnesota, Minneapolis, MN, USA.
6
Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC, USA.
7
Sheba Medical Center, Ramat Gan, Israel.
8
Yale Cancer Center, New Haven, CT, USA.
9
Fox Chase Cancer Center, Philadelphia, PA, USA.
10
National Cancer Center Hospital East, Chiba, Japan.
11
Seoul National University Hospital, Seoul, Republic of Korea.
12
Johns Hopkins University, Baltimore, MD, USA.
13
Aichi Cancer Center Hospital, Nagoya, Japan.
14
Sourasky Medical Center, Tel Aviv, Israel.
15
Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
16
National Taiwan University Hospital, Taipei, Taiwan.
17
Merck & Co., Inc, Kenilworth, NJ, USA.
18
University of Washington, Seattle, WA, USA.
19
Dana-Farber Cancer Institute, Boston, MA, USA.

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.

PMID:
29955135
PMCID:
PMC6048158
DOI:
10.1038/s41416-018-0131-9
[Indexed for MEDLINE]
Free PMC Article

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