+1 Recommend
0 collections
      • Record: found
      • Abstract: found
      • Article: not found

      Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study.

      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.


          Purpose To establish the safety profile and antitumor activity of the anti-programmed death 1 receptor monoclonal antibody, pembrolizumab, in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) that expressed programmed death-ligand 1 (PD-L1). Patients and Methods KEYNOTE-028 (NCT02054806) is a nonrandomized, multicohort, phase Ib trial of pembrolizumab in patients with PD-L1-positive advanced solid tumors. Key eligibility criteria for the NPC cohort included unresectable or metastatic disease, failure on prior standard therapy, and PD-L1 expression in 1% or more of tumor cells or tumor-infiltrating lymphocytes. Patients received pembrolizumab 10 mg/kg every 2 weeks up to 2 years or until disease progression or unacceptable toxicity. Primary end point was objective response rate (ORR) per investigator review. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) every 8 weeks for the first 6 months and every 12 weeks thereafter. Results Twenty-seven patients received pembrolizumab. Median age was 52.0 years (range, 18 to 68 years); 92.6% received prior therapies for RM-NPC; 70.4% had received three or more therapies. Partial response and stable disease were observed in seven and 14 patients, respectively, for an ORR of 25.9% (95% CI, 11.1 to 46.3) over a median follow-up of 20 months. ORR by central review was similar (26.3%). Drug-related adverse events that occurred in 15% or more of patients included rash (25.9%), pruritus (25.9%), pain (22.2%), hypothyroidism (18.5%), and fatigue (18.5%). Grade ≥ 3 drug-related adverse events occurred in eight patients (29.6%), and there was one drug-related death (sepsis). As of the data cutoff (June 20, 2016), two patients remained on pembrolizumab treatment. Conclusion Pembrolizumab demonstrated antitumor activity and a manageable safety profile in patients with RM-NPC.

          Related collections

          Author and article information

          J. Clin. Oncol.
          Journal of clinical oncology : official journal of the American Society of Clinical Oncology
          American Society of Clinical Oncology (ASCO)
          Dec 20 2017
          : 35
          : 36
          [1 ] Chiun Hsu, National Taiwan University Hospital, Graduate Institute of Oncology, National Taiwan University College of Medicine, and National Taiwan University Cancer Center, Taipei, Taiwan, Republic of China; Se-Hoon Lee, Seoul National University Hospital, Seoul, South Korea; Samuel Ejadi, Virginia G. Piper Cancer Center, Scottsdale, AZ; Roger B. Cohen, University of Pennsylvania, Philadelphia, PA; Janice M. Mehnert, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Alain Algazi, University of California, San Francisco, San Francisco, CA; Sanatan Saraf, Pradeep Thanigaimani, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ; Caroline Even, Gustave Roussy, Villejuif; Christophe Le Tourneau, Institut Curie, Paris; Christophe Le Tourneau, INSERM U900 Research Unit, Saint-Cloud, France; Emilie M.J. van Brummelen, Netherlands Cancer Institute, Amsterdam, the Netherlands; and Aaron R. Hansen, Princess Margaret Cancer Centre, Toronto, ON, Canada.


          Comment on this article