News|Articles|February 11, 2019

FDA Grants Priority Review to Frontline Keytruda to Treat Recurrent, Metastatic HNSCC

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Key Takeaways

Keytruda's priority review for HNSCC is based on the pivotal KEYNOTE-048 trial, showing improved overall survival compared to standard care.
The trial evaluated Keytruda as monotherapy and in combination with chemotherapy, focusing on overall and progression-free survival as co-primary endpoints.
Secondary endpoints included objective response rate, quality of life measures, and safety, with significant results favoring Keytruda.
The FDA's target action date for the review of Keytruda's application is set for June 10, 2019.

The Food and Drug Administration granted a priority review to the supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The Food and Drug Administration (FDA) granted a priority review to the supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), according to Merck, the drug’s manufacturer.

“Head and neck cancer remains a challenging and devastating disease, and newly diagnosed patients are in need of improved treatment options,” said Jonathan Cheng, M.D., vice president of clinical research at Merck Research Laboratories, said in a press release. “Merck continues to make meaningful advances in the treatment of head and neck cancer, and we look forward to working with the FDA to bring these important new options to patients in the first-line setting.”

The application — which included Keytruda as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy – was based in part on data from the pivotal, randomized, open-label phase 3 KEYNOTE-048 trial, designed to evaluate both Keytruda regimens compared with Erbitux (cetuximab) as first-line treatment in 882 patients with recurrent or metastatic HSNCC.

Overall and progression-free survival served as the co-primary endpoints, while secondary endpoints included progression-free survival at six and 12 months, objective response rate and time to deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and Safety.

The anti-PD-1 therapy demonstrated a significant improvement in overall survival compared with the standard of care, as monotherapy in patients whose tumors expressed PD-L1 with a combined positive score of 20 or less and a score of 1 or less (which considers PD-L1 expression on tumor cells and immune cells combined) and in combination with chemotherapy in the total patient population.

The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2019.