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FDA approves Keytruda for recurrent, metastatic HNSCC
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The FDA expanded the approval of pembrolizumab to include treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy.
Pembrolizumab (Keytruda, Merck) — an anti–PD-1 therapy — is approved at a fixed dose of 200 mg every 3 weeks based on tumor response rate and durability of response.
Tanguy Seiwert
“Head and neck cancer is a complex disease that historically has been associated with high recurrence rates and poor long-term outcomes, highlighting the critical need for new treatment options,” Tanguy Seiwert, MD, associate director of the head and neck cancer program and assistant professor of medicine at The University of Chicago, said in a Merck-issued press release. “The approval of Keytruda for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma is an important step forward in treating this disease.”
The FDA based its approval on data from the multicenter, nonrandomized, open-label KEYNOTE-012 study.
Researchers evaluated pembrolizumab, a humanized monoclonal antibody, in 174 patients with recurrent or metastatic HNSCC whose disease progressed on or after platinum-containing chemotherapy, or following platinum-containing chemotherapy administered as part of induction, concurrent or adjuvant therapy. All study participants had ECOG performance status of 0 or 1.
Fifty-three patients received 10 mg/kg pembrolizumab every 2 weeks. The other 121 patients received a fixed dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression.
Median follow-up was 8.9 months.
Results showed an objective response rate of 16% (95% CI, 11-22) and a complete response rate of 5%. Median duration of response had not been reached (range, 2.4+ to 27.7+), but 23 of the 28 patients who achieved responses sustained their responses for at least 6 months.
ORR and duration of response were similar regardless of dosage regimen or HPV status.
The most common adverse reactions included fatigue (46%), decreased appetite (22%) and dyspnea (20%).
Forty-five percent of patients experienced serious adverse reactions, the most common of which were pneumonia, dyspnea, confusional state, vomiting, pleural effusion and respiratory failure.
The incidence of adverse reactions, including serious adverse reactions, was similar between dosage regimens.
“[This] approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in the press release. “Together with prior approvals in the treatment of other tumor types, [this] action by the FDA underscores our tireless commitment to addressing the unmet needs of patients suffering from a broad range of cancers.”
The FDA previously approved pembrolizumab for treatment of patients with unresectable or metastatic melanoma, as well as for patients with metastatic non–small cell lung cancer whose tumors express PD-L1.