The U.S. Food and Drug Administration will be giving priority review to Merck’s Keytruda (pembrolizumab) as a treatment for women whose advanced cervical cancer progressed during or after chemotherapy.
Priority review means the agency will decide whether to approve the Biologics License Application (sBLA) for Keytruda within six months, compared with the normal 10 months. A decision is expected by June 28.
Merck based the application partly on the results of the ongoing Phase 2 KEYNOTE-158 clinical trial (NCT02628067). The global, open-label, multi-center study enrolled patients with multiple types of advanced solid tumors — including cervical cancer — that had failed to respond to standard therapy.
The decision marks the first time the FDA has accepted, and agreed to a priority review of, an anti-PD-1 therapy in cervical cancer, Merck said. PD-1 is a protein associated with many cancers.
Researchers presented the trial results at the American Society of Clinical Oncology Annual Meeting in 2017. They showed that 17% of cervical cancer patients responded to Keytruda, whether or not their tumor had PD-L1, another protein associated with cancer. The response rates rose to 27% among patients followed at least 27 weeks.
Researchers continue to recruit patients for KEYNOTE-158. You can find more information about that here. Merck anticipates enrolling 1,350 patients and completing the study by August 2023.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. We look forward to working with the FDA on the review of this application to help bring Keytruda to previously treated patients with advanced cervical cancer,” Roger Dansey, senior vice president of Merck Research Laboratories, said in a press release.
Over 12,000 cases of cervical cancer were diagnosed in the U.S. in 2017. Diagnosis is more common in women aged 35-44. Although screenings and vaccinations have reduced cervical cancer rates, the disease still poses a major threat to women throughout the world.
Keytruda is an anti-PD-1 antibody that blocks the interaction between PD-1 and its ligands, or molecules it binds to. Preventing the binding allows immune T-cells to detect cancer that contains the protein.
Merck’s clinical trial program for Keytruda is the largest in immuno-oncology. It currently involves over 700 trials in multiple cancers and treatment settings.
Keytruda is approved in the U.S. and the E.U. to treat a wide range of advanced cancers. These include melanoma, head and neck squamous cell carcinoma, Hodgkin’s lymphoma, gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, locally advanced or metastatic urothelial carcinoma, and metastatic non-small cell lung cancer.