Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
July 25, 2017
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Pembrolizumab fails to improve survival in head and neck squamous cell carcinoma

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The pivotal phase 3 trial designed to evaluate pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma failed to meet its prespecified primary endpoint of OS, according to the drug’s manufacturer.

The randomized, multicenter, pivotal phase 3 KEYNOTE-040 trial compared single-agent pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, with standard treatment in 495 patients with recurrent or metastatic HNSCC who were previously treated with one to two lines of platinum-containing systemic regimens.

The FDA granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy in Aug. 2016 based on improvement in response rate. Following that approval, Merck was required to conduct the current trial to verify the clinical benefit in this population.

Researchers randomly assigned patients to receive 200 mg pembrolizumab every 3 weeks or investigator-choice chemotherapy.

OS served as the primary endpoint. Secondary endpoints included PFS and overall response rate.

Pembrolizumab failed to improve OS (HR = 0.82; 95% CI, 0.67-1.01) compared with standard treatment.

The safety profile appeared consistent with previous studies with no new safety signals.

“We are encouraged by the positive impact that Keytruda has had on many cancer patients, including those with previously treated recurrent or metastatic head and neck cancer, and we remain confident that Keytruda is an important therapy for this difficult-to-treat cancer,” Roger Dansey, MD, senior vice president and therapeutic area head of, oncology late-stage development at Merck Research Laboratories, said in a company-issued release. “We look forward to sharing the comprehensive data analysis from KEYNOTE-040 with the scientific community at an upcoming medical meeting.”

The agent’s clinical development program includes more than 500 trials designed to evaluate pembrolizumab in over 30 tumor types, including melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma and microsatellite instability-high solid tumors.