other material
confidence high
sentiment positive
materiality 0.80
Zentalis first patient dosed in Phase 3 ASPENOVA trial for azenosertib in Cyclin E1+ PROC
Zentalis Pharmaceuticals, Inc.
- Phase 3 ASPENOVA compares azenosertib 400mg QD 5:2 to standard-of-care chemo in ~420 Cyclin E1+ platinum-resistant ovarian cancer patients.
- Trial designed as confirmatory study to support full approval, with DENALI Part 2 topline expected by year-end 2026 for accelerated approval path.
- 400mg QD 5:2 dose selected based on DENALI Part 2a interim analysis showing differentiated response rate over 300mg with comparable safety.
- Collaborators include GOG Foundation, ENGOT, and APGOT; trial identifier NCT07546500.