- Merck's Phase 3 KEYNOTE-B96 trial achieves primary endpoint in ovarian cancer treatment.
- KEYTRUDA® (pembrolizumab) regimen shows significant progression-free survival and overall survival benefits.
- Results marked the first overall survival benefit demonstration by an immune checkpoint inhibitor-based regimen in ovarian cancer.
Merck (MRK, Financial), operating as MSD outside the U.S. and Canada, has announced encouraging results from its Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65. This trial involved patients with platinum-resistant recurrent ovarian cancer, exploring the efficacy of KEYTRUDA® (pembrolizumab) combined with chemotherapy (paclitaxel) with or without bevacizumab.
The study successfully met its primary endpoint of progression-free survival (PFS) in patients with PD-L1 expressing tumors and the secondary endpoint of overall survival (OS) in this subgroup. This marks a significant achievement as the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in OS among patients expressing PD-L1 compared to the placebo group.
The safety profile of KEYTRUDA in the trial was consistent with previous studies, with no new safety signals identified. The trial's positive outcomes underscore the potential of KEYTRUDA across various gynecological cancers, providing new hope for patients with this challenging form of ovarian cancer. Merck plans to present these findings at an upcoming medical meeting and will share results with global regulatory authorities.
