This article is more than 5 years old. Information may no longer be current.
FDA grants priority review to Keytruda for first-line treatment of advanced head and neck cancer
The FDA granted priority review to pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
The designation applies to use of pembrolizumab (Keytruda, Merck) — an anti-PD-1 agent — as monotherapy or in combination with platinum and 5-FU chemotherapy.
The FDA based the priority review designation on OS results from the randomized phase 3 KEYNOTE-048 trial, which included 882 patients with recurrent or metastatic HNSCC.
Researchers compared pembrolizumab monotherapy or pembrolizumab plus chemotherapy with the EXTREME regimen. EXTREME — the standard first-line treatment for recurrent or metastatic HNSCC — consists of the EGFR inhibitor cetuximab (Erbitux, Eli Lilly) plus carboplatin or cisplatin.
OS and PFS served as dual primary endpoints. PFS at 6 months and 12 months, objective response rate, and time to deterioration in quality of life served as secondary endpoints.
Median follow-up was 11.7 months for patients assigned pembrolizumab monotherapy, 13 months for those assigned pembrolizumab plus chemotherapy, and 10.7 months for those assigned the EXTREME regimen.
The results, presented in October at European Society for Medical Oncology Congress, showed pembrolizumab monotherapy prolonged OS compared with EXTREME among patients whose tumors had PD-L1 combined positive score (CPS) of 20 or higher, as well as those who had CPS of 1 or higher. The combination of pembrolizumab plus chemotherapy prolonged OS compared with EXTREME among 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,” Jonathan Cheng, MD, vice president for clinical research at Merck Research Laboratories, said in a company-issued 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 FDA is expected to make a decision on Merck’s biologics license application by June 10.
Pembrolizumab already is approved for the treatment of patients with recurrent or metastatic HNSCC whose disease progressed on or after platinum-containing chemotherapy.
The agent also is approved for treatment of specific patient groups with melanoma, lung cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, Merkel cell carcinoma and microsatellite instability-high cancers.