359O_PR - Efficacy and safety of pembrolizumab (MK-3475) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Subset analyses for Asia-...

Date 16 December 2016
Event ESMO Asia 2016 Congress
Session Head and neck cancer
Topics Immunotherapy
Head and Neck Cancers
Presenter Makoto Tahara
Citation Annals of Oncology (2016) 27 (suppl_9): ix112-ix122. 10.1093/annonc/mdw587
Authors M. Tahara1, K. Muro2, Y. Hasegawa3, H.C. Chung4, C. Lin5, B. Keam6, J. Cheng7, Y. Bang8
  • 1Department Of Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 3Head And Neck Surgery, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4Medical Oncology, Yonsei Cancer Center, 120-752 - Seoul/KR
  • 5Oncology, National Taiwan University Hospital, 10002 - Taipei/TW
  • 6Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 7Merck Research Laboratories, Merck Sharpe and Dohme, 19454 - Kenilworth/US
  • 8Medical Oncology, Seoul National University Hospital, 110-744 - Seoul/KR



The PD-1 pathway is a key mechanism by which R/M HNSCC tumors evade immune surveillance. MK-3475, an anti–PD-1 antibody, shows promising antitumor activity in R/M HNSCC in KN-012 (NCT01848834). We present a subset analysis for long-term follow-up of the efficacy and safety of MK-3475 in Asia-pacific R/M HNSCC patients (pts)


Pts had R/M HNSCC, measurable disease by RECIST v1.1, and ECOG PS 0-1. Pts were enrolled regardless of PD-L1 status. MK-3475 200 mg Q3W was given for 24 months (mo) or until disease progression, unacceptable safety, or investigator/pt decision. Response was assessed every 8 weeks. AEs were graded using CTCAE v4.0. The primary end point was ORR per central imaging vendor review. Secondary end points included PFS, OS, and duration of response (DOR). Pts who received ≥ 1 dose of MK-3475 were included in these pooled analyses.


Out of 132 pts in KN-012 B2 cohort, 26 Asia-pacific R/M HNSCC pts were enrolled and received MK-3475. 3 (12%) pts were still on treatment as of April 26, 2016. Median age was 61.5 y; 85% were male; 65% had ECOG PS 1; 62% received ≥ 2 lines of chemotherapies for recurrent disease. ORR (confirmed) was 19.2% (95% CI, 6.6%-39.4%; no CR, 5 PRs). 8 (30.8%) pts achieved stable disease. Median follow-up duration in responders was 19.4 mo (range, 18.4-20.6). At the data cutoff, median DOR was not yet reached (range, 5.8 to 16.8+ mo); responses were ongoing in 4 (80%) pts. Responses of ≥ 6 mo and ≥ 12 mo were noted in 4 pts and 3 pts. Median OS was 11.6 mo (95% CI, 4.7-17.7.). The 6-mo PFS and OS rates were 20.0% and 58.5%, respectively. Treatment-related AEs (TRAEs) occurred in 16 (62%) pts; 2 (8%) pts had a grade 3-4 TRAE. No death due to a TRAE was observed.


Robust antitumor activity with durable responses and promising survival suggested that MK-3475 200 mg Q3W is an active treatment in Asia-pacific R/M HNSCC pts. MK-3475 was safe and well tolerated in Asia-pacific R/M HNSCC pts.

Clinical trial indentification


Legal entity responsible for the study

Merck Sharp and Dohme


Merck Sharp and Dohme


J. Cheng: Employee of Merck Sharpe and Dohme. All other authors have declared no conflicts of interest.