Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“February 20th next year is a date when great news for patients with platinum-resistant recurrent ovarian cancer can come as Merck announces that time for the FDA Prescription Drug User Fee Act (PDUFA) decision on impressive results of Phase III KEYNOTE-B96, also known as ENGOT-ov65 trial.
Trial has been just presented at ESMO2025 Presidential Symposium where Keytruda (Pembrolizumab) plus chemotherapy with or without bevacizumab delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) vs chemo with or without bevacizumab in patients whose tumors express PD-L1 (CPS ≥1).
This Keytruda combination will be the first immunotherapy demonstrating improved survival in this patient population that currently have very large medical need. Congratulations to Merck Women’s Cancer team and outstanding expert, innovative leader and trailblazer in bringing new therapies to patients Gursel Aktan!”
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