315O_PR - Antitumor activity and safety of pembrolizumab in patients with PD-L1-positive nasopharyngeal carcinoma: Interim results from a phase 1b study

Date 18 December 2015
Event ESMO Asia 2015 Congress
Session Head and neck cancer
Topics Immunotherapy
Head and Neck Cancers
Presenter Chiun Hsu
Citation Annals of Oncology (2015) 26 (suppl_9): 93-102. 10.1093/annonc/mdv527
Authors C. Hsu1, S. Lee2, S. Ejadi3, C. Even4, R. Cohen5, C. Le Tourneau6, J. Mehnert7, A. Algazi8, E. van Brummelen9, S. Saraf10, P. Thanigaimani10, J. Cheng10, A. Hansen11
  • 1Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 2Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 3Clinical Trials, Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale/US
  • 4Head And Neck Department, Institut Gustave Roussy, Villejuif/FR
  • 5Division Of Hematology And Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia/US
  • 6Dept Of Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 7Medical Oncology, The Cancer Institute of New Jersey, New Brunswick/US
  • 8Medicine (hematology/oncology), University of California San Francisco, San Francisco/US
  • 9Clinical Pharmacology, The Netherlands Cancer Institute, Amsterdam/NL
  • 10,, Merck & Co., Inc., Kenilworth/US
  • 11Medical Oncology And Hematology, Princess Margaret Cancer Centre, Toronto/CA



Nasopharyngeal carcinoma (NPC) exhibits high expression of PD-1, and expression of PD-1/PD-L1 correlated with poor outcome. Pembrolizumab is a potent, highly selective, humanized monoclonal antibody against PD-1 designed to block interaction with PD-L1 and PD-L2 and enhance antitumor immune response. We present results on safety and antitumor activity of pembrolizumab in patients (pts) with PD-L1+ advanced NPC.


KEYNOTE-028 (NCT02054806) is a nonrandomized, multicohort, phase 1b trial of pembrolizumab in pts with PD-L1+ advanced solid tumors. Key eligibility criteria for the NPC cohort included advanced (unresectable and/or metastatic) solid tumor, failure of prior therapy, and PD-L1 expression in ≥1% of cells in tumor nests or PD-L1+ bands in stroma as determined by a prototype immunohistochemical assay at a central laboratory. Pembrolizumab 10 mg/kg was given every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Primary end points were safety, tolerability, and preliminary efficacy. Response was assessed per RECIST v1.1 by investigators every 8 weeks for the first 6 months and every 12 weeks thereafter.


27 pts were treated with pembrolizumab. Median (range) age was 52.0 (18-68) years; 63% were Asian. 92.5% received prior therapies for recurrent/metastatic disease (33.3% received ≥5 therapies). 7 pts experienced partial response and 14 had stable disease. Best overall (confirmed and unconfirmed) response rate was 25.9% (95% CI, 11.1-46.3). Most common adverse events (AEs) (≥20%) were fatigue (37.0%), pruritus (29.6%), nausea (25.9%), pyrexia (25.9%), and myalgia (22.2%). Drug-related AEs occurred in 74.1% of pts; most common (≥10%) were pruritus (25.9%), fatigue (18.5%), hypothyroidism (18.5%), rash (11.1%), maculopapular rash (11.1%), pneumonitis (11.1%), herpes zoster infection (11.1%), and hepatitis (11.1%); grade ≥3 drug-related AEs occurred in 8/27 (29.6%) pts. 5 pts remain on pembrolizumab treatment.


Pembrolizumab was well tolerated with significant antitumor activity in pts with NPC. This preliminary signal will be further investigated.

Clinical trial identification



J. Mehnert: Advisory board member for Amgen; research funding from Amgen, Novartis, Merck & Co., Inc., and Sanofi-aventis. A. Algazi: research funding from Merck & Co., Inc. S. Saraf: employee of Merck & Co., Inc. P. Thanigaimani: employee of Merck & Co., Inc. Owns stock in Gilead Sciences. J. Cheng: employee of and owns stock in Merck & Co., Inc. All other authors have declared no conflicts of interest.