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FDA Approves Pembrolizumab (Keytruda®), a PD-1 Antibody, for Head and Neck Cancer

August 08, 2016 | Alexandra Mulvey

On Friday, the FDA announced its approval of pembrolizumab (Keytruda®) to treat recurrent or metastatic head and neck cancer that has failed to respond to chemotherapy. The drug, which targets the PD-1 molecule found on immune cells, “releases the brakes” on the immune system, enabling a stronger attack against cancer. Pembrolizumab, manufactured by Merck, is the first checkpoint inhibitor to receive FDA approval for head and neck cancer.

The accelerated approval for this was based on results from the phase Ib trial KEYNOTE-012  (NCT01848834). This trial enrolled 192 patients with head and neck cancer who were given pembrolizumab after they failed chemotherapy. Patients had an objective response rate of 16%, with 5% of patients experiencing a complete response. Immunotherapy can also provide durable responses. In this study, 82% of patients who responded saw their responses last at least 6 months. The median overall survival was 9.6 months, compared to the historical median overall survival of only 6 months in this patient population.


Head and Neck Cancer

  • A collective term that includes tumors that develop in or around the throat, voice box, sinuses, and mouth

  • In 2016, approximately 62,000 people will develop one of these cancers in the United States, and 13,000 will die

  • With treatment, the goal is not only to remove the cancer, but also to preserve the functions of the structures involved in speaking, swallowing, and expression

  • Risk factors for head and neck cancers include tobacco use and alcohol consumption, along with infection with human papillomavirus (HPV)


“Survival rates for advanced head and neck cancer remain dismal, and there are no consistently-effective treatments in the second-line setting,” said Andrew G. Sikora, M.D., Ph.D., a head and neck cancer expert who was not on the trial, who serves as associate professor of otolaryngology and co-director of the Head and Neck Cancer Program at Baylor College of Medicine and is a CRI Clinical Trial Scientific Advisory Committee member. “Advances in immunomodulatory agents, like pembrolizumab, are offering hope that we can treat patients in the second-line, get responses like those seen in the pembro trial, and, hopefully, move toward a cure for head and neck cancer.”

CRI has been instrumental in the development of anti-PD-1/PD-L1 immunotherapies. We funded research in four laboratories that helped discover the PD-1 pathway and establish it as a new target for cancer immunotherapy drugs. For this groundbreaking work, CRI honored these researchers with the 2014 William B. Coley Award for Distinguished Research in Tumor Immunology.

Since 2014, PD-1 pathway drugs—which, aside from pembro, include Bristol-Myers Squibb’s nivolumab (Opdivo®) and Genentech’s atezolizumab (Tecentriq™)—have been FDA-approved for melanoma, non-small cell lung cancer, kidney cancer, Hodgkin lymphoma, and bladder cancer.

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