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ECC 2015: Pembrolizumab in Patients With Advanced Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Trial

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Key Points

  • Early findings from 27 heavily pretreated patients with advanced nasopharyngeal carcinoma demonstrated an overall response rate of 22.2%, with six partial responses.
  • Additionally, 55.6% of patients had stable disease, the disease control rate was 77.8%, and tumor shrinkage was achieved in 67% of patients.
  • The 6-month progression-free survival rate was 49.7%, and the 12-month progression-free survival rate was 28.9%.

Pembrolizumab (Keytruda), an anti–PD-1 therapy, may be effective as monotherapy in patients with advanced unresectable nasopharyngeal carcinoma whose tumors express programmed cell death-ligand 1 (PD-L1). Data from a phase Ib study, KEYNOTE-028, showed an overall response rate of 22.2% in 27 evaluable patients who were treated with pembrolizumab.

Chiun Hsu, MD, of the National Taiwan University Hospital, presented results from the trial at the 2015 European Cancer Congress in Vienna, Austria (Abstract 2801).

“Advanced nasopharyngeal carcinoma is a severe form of head and neck cancer often associated with a poor prognosis,” said Dr. Hsu. “These data represent the potential for new approaches to treat this type of cancer, for which there are currently limited options, and further support the need for additional research into how pembrolizumab may work for certain types of head and neck cancer.”

Merck has initiated a comprehensive clinical development program evaluating pembrolizumab in head and neck cancer across multiple lines of therapy as monotherapy and in combination with chemotherapy as well as other agents. In KEYNOTE-028, pembrolizumab is being evaluated in patients with advanced unresectable nasopharyngeal carcinoma that is not responding to current therapy or for which current therapy is not appropriate. This is the second study to show early activity of pembrolizumab in patients with head and neck cancer, and the first study of an anti–PD-1 therapy to demonstrate clinical activity in patients with recurrent or metastatic nasopharyngeal carcinoma.

Trial Details

KEYNOTE-028 is an ongoing multicohort, nonrandomized phase Ib basket trial evaluating the safety, tolerability, and antitumor activity of pembrolizumab monotherapy (10 mg/kg dosed every 2 weeks) in more than 450 patients across 20 different tumor types. The study was designed to evaluate patients with advanced solid tumors that express PD-L1 and have not responded to current therapy or for which current therapy is not appropriate.

These early findings from 27 heavily pretreated patients with advanced nasopharyngeal carcinoma demonstrated an overall response rate of 22.2% (n = 6/27; per RECIST v1.1), including six partial responses (95% confidence interval [CI], 8.6–42.3). Additionally, 55.6% of patients had stable disease (n = 15/27; 95% CI, 35.3–74.5); the disease control rate was 77.8% (n = 21/27; 95% CI, 57.7–91.4); and tumor shrinkage was achieved in 67% of patients. The 6-month progression-free survival rate was 49.7%, and the 12-month progression-free survival rate was 28.9%. The median follow-up duration for evaluable patients was 12.9 months (range, 2.2−15.0), and the median response duration was 10.8 months (range, 4.8–10.8).

Adverse events were generally consistent with previously reported safety data for pembrolizumab. Grade 3-5 investigator-assessed, treatment-related adverse events were hepatitis (n = 2); pneumonitis (n = 2); anemia (n = 1); facial pain (n = 1); increased blood creatine phosphokinase (n = 1); proteinuria (n = 1); and sepsis (n = 1). Immune-mediated adverse events were hypothyroidism (n = 5), hepatitis (n = 4), and pneumonitis (n = 3). There was one treatment-related death due to bacterial sepsis.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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