Study Finds Pembrolizumab Active in Advanced Head and Neck Cancer


Key Points

  • Pembrolizumab showed activity in patients with PD-L1–positive recurrent or metastatic squamous cell carcinoma of the head and neck.
  • Treatment was well tolerated.

As reported by Seiwert et al in The Lancet Oncology, the monoclonal antibody pembrolizumab (Keytruda) showed activity in patients with programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic squamous cell carcinoma of the head and neck in the phase Ib KEYNOTE-012 study.

Study Details

In the study, 60 patients with any level of PD-L1 expression (≥ 1% of tumor cells or stroma PD-L1–positive on immunohistochemistry) were treated with pembrolizumab at 10 mg/kg every 2 weeks. In total, 38% were human papillomavirus (HPV)-positive and 62% were HPV-negative; 82% were male; and 85% had received at least one line of therapy for recurrent or metastatic disease.

Response Rate

On central imaging review among 45 evaluable patients with baseline and at least one post-baseline tumor measurement, response was achieved in 8 patients (18%), including 4 of 16 (25%) HPV-positive patients and 4 of 29 (14%) HPV-negative patients. Complete response was observed in one patient, partial response was seen in seven patients, and stable disease was found in eight patients (18%).

On investigator review, response was observed in 12 of 56 (21%) evaluable patients, including 25% of HPV-positive and 19% of HPV-negative patients. Median time to response was 8 weeks, and median duration of response was 53 weeks.

Adverse Events

Grade 3 drug-related adverse events occurred in 10 of 60 (17%) patients, with the most common being increased aspartate transaminase, increased alanine transaminase, and hyponatremia (3% each); no drug-related grade 4 adverse events were reported. Serious adverse events occurred in 45% of patients. Treatment was discontinued due to adverse events in 13%. No drug-related deaths were observed.

The investigators concluded: “Pembrolizumab was well tolerated and demonstrated clinically meaningful antitumour activity in recurrent or metastatic squamous cell carcinoma of the head and neck, supporting further study of pembrolizumab as anticancer therapy for advanced head and neck cancers.”

The study was funded by Merck & Co.

Tanguy Seiwert, MD, of the University of Chicago Medical Center, is the corresponding author of The Lancet Oncology article.

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®.