Safety and antitumor activity of pembrolizumab in patients with programmed death-ligand 1-positive nasopharyngeal carcinoma: Results of the KEYNOTE-028 study

Chiun Hsu, Se Hoon Lee, Samuel Ejadi, Caroline Even, Roger B. Cohen, Christophe Le Tourneau, Janice M. Mehnert, Alain Algazi, Emilie M.J. Van Brummelen, Sanatan Saraf, Pradeep Thanigaimani, Jonathan D. Cheng, Aaron R. Hansen

Research output: Contribution to journalArticlepeer-review

169 Scopus citations

Abstract

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) overamedian 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.

Original languageEnglish (US)
Pages (from-to)4050-4056
Number of pages7
JournalJournal of Clinical Oncology
Volume35
Issue number36
DOIs
StatePublished - Dec 20 2017

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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