The FDA has approved Merck’s Keytruda (pembrolizumab) and Keytruda QLEX in combination with paclitaxel, with or without bevacizumab, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1. This is the first PD-1 inhibitor approved for platinum-resistant ovarian cancer.
The approval is based on the Phase 3 KEYNOTE-B96 trial, which showed the Keytruda regimen reduced the risk of disease progression or death by 28% and reduced the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab in patients whose tumors express PD-L1.
Median progression-free survival was 8.3 months for patients receiving the Keytruda regimen versus 7.2 months for the placebo regimen. Median overall survival was 18.2 months versus 14.0 months.
“For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback – it’s when options can become limited, and the reality patients face can change very quickly,” said Dr. Bradley Monk, gynecologic oncologist and medical director of the Late-Stage Clinical Research Program at Florida Cancer Specialists and Research Institute. “For patients who have been previously treated with standard platinum-based therapies, the FDA approvals of these pembrolizumab-based regimens offer the possibility of more time.”
Over 80% of patients diagnosed with ovarian cancer experience disease progression following standard treatment with platinum-based chemotherapy. Approximately 25% develop resistance within six months of completing first-line treatment.
In the United States, an estimated 21,010 patients will be diagnosed with ovarian cancer and approximately 12,450 will die from the disease in 2026.
Agilent’s PD-L1 IHC 22C3 pharmDx test was approved as the companion diagnostic to identify eligible patients.
