FDA Grants Priority Review to Keytruda for First-Line Treatment of Head and Neck Cancer


The supplemental Biologics License Application was filed based on positive overall survival data from a phase 3 clinical trial for pembrolizumab in the treatment of recurrent or metastatic head and neck squamous cell carcinoma.

Officials with the FDA have granted Priority Review to Merck’s supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), according to a press release.

The new indication would include pembrolizumab’s use as a monotherapy or in combination with platinum and 5-flourouracil (5-FU) chemotherapy in this patient population. The current standard of care for HNSCC is platinum-based chemotherapy plus the EGFR inhibitor cetuximab.

The FDA’s acceptance of the sBLA is based on data from the phase 3 KEYNOTE-048 clinical trial evaluating pembrolizumab compared with the standard of care in 822 patients with recurrent or metastatic HNSCC. According to the data, pembrolizumab demonstrated a significant improvement in overall survival (OS) compared with the standard as a monotherapy in patients whose tumors expressed PD-L1 with combined positive score (CPS)≥20 and CPS≥1 and in combination with chemotherapy in the total patient population.

“Head and neck cancer remains a challenging and devastating disease, and newly diagnosed patients are in need of improved treatment options,” Dr Jonathan Cheng, vice president of clinical research at Merck Research Laboratories, said in a statement. “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.”

Data from the KEYNOTE-048 trial were presented at the European Society for Medical Oncology 2018 Congress.

In the first group comparing pembrolizumab alone versus standard treatment in patients expressing PD-L1 with CPS≥20, 301 patients received pembrolizumab and 300 received standard treatment with a median follow up of 11.7 and 10.7 months, respectively. OS was significantly longer in patients treated with pembrolizumab (14.9 months) than standard treatment (10.7 months, hazard ratio [HR] 0.61, p=0.0007), according to the data. Median response duration was longer with pembrolizumab (20.9 months) than standard therapy (4.5 months). The study showed no difference in progression-free survival (PFS) between groups.

In patients with lower PD-L1 expression (CPS≥1), OS was also significantly improved with pembrolizumab (12.3 months) compared with standard care (10.3 months, HR 0.78, p=0.0086). Median response duration was longer with pembrolizumab (20.9 months) than standard chemotherapy (4.5 months). There was no difference in PFS between the groups.

Pembrolizumab combined with platinum-based chemotherapy also demonstrated improved OS compared with standard therapy. In this comparison, 281 patients received pembrolizumab plus chemotherapy and 278 received standard treatment, with a median follow up of 13 and 10.7 months, respectively. The combination prolonged OS (13 months) versus standard care (10.7 months, HR 0.77, p=0.0034).

The FDA has set a target action of June 10, 2019, according to the release.


FDA Grants Priority Review to Merck’s 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) [news release]. Merck’s website. https://bit.ly/2MXWNPw. Accessed February 11, 2019.

Immunotherapy improves survival in metastatic or recurrent head and neck cancer [ESMO 2018 press release]. ESMO. https://bit.ly/2E516ps. Accessed February 11, 2019.

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