Results of the phase 3 KEYNOTE-826 trial showed the combination of pembrolizumab and chemotherapy met its primary endpoints of overall survival and progression-free survival for the first line treatment patients with persistent, recurrent, or metastatic cervical cancer.
Patients enrolled in the trial were randomized to receive either pembrolizumab plus one of four investigator’s choice platinum-based chemotherapy options or placebo and platinum-based chemotherapy. The chemotherapy options included paclitaxel plus cisplatin with or without bevacizumab or paclitaxel plus carboplatin with or without bevacizumab.
According to a release from the manufacturer, pembrolizumab plus chemotherapy was effective compared with the same platinum-based chemotherapy regimen with or without bevacizumab alone, regardless of PD-L1 status.
“Despite progress with prevention and screening, cervical cancer continues to be a major health problem, often affecting younger and middle-aged women,” Roy Barnes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in the release. “Women diagnosed with metastatic cervical cancer have a particularly poor prognosis, and there is an urgent need for new treatment options.”
The trial is the first to show the benefits of immunotherapy as a first-line treatment for persistent, recurrent, or metastatic cervical cancer. The release noted that the trial also served as a confirmatory trial as part of pembrolizumab’s accelerated approval as a second-line treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test.
Full results from the trial are expected to be presented at an upcoming medical conference.