- KEYTRUDA plus chemotherapy reduced disease progression risk by 30% in platinum-resistant ovarian cancer.
- The FDA has set a target action date of Feb. 20, 2026, for the supplemental Biologics License Application.
- The KEYNOTE-B96 trial involved 643 patients with a median follow-up of 26.6 months.
- Treatment-related adverse events occurred in 97.8% of patients receiving the KEYTRUDA regimen.
Trial Results
The Phase 3 KEYNOTE-B96 trial demonstrated that KEYTRUDA combined with chemotherapy, with or without bevacizumab, significantly improved progression-free survival in patients with platinum-resistant recurrent ovarian cancer. The trial showed a 30% reduction in the risk of disease progression or death compared to placebo.
FDA Review
Based on these findings, the U.S. FDA has accepted a supplemental Biologics License Application for priority review. The target action date for this review is set for February 20, 2026.
Patient Data
The trial involved 643 patients, with a median follow-up of 26.6 months. In patients whose tumors express PD-L1, the KEYTRUDA regimen reduced the risk of death by 24% compared to placebo.
Adverse Events
Treatment-related adverse events were reported in 97.8% of patients receiving the KEYTRUDA regimen, with Grade 3-5 events occurring in 67.5% of these patients. Immune-mediated adverse events and infusion reactions were noted in 39.1% of patients.
