Zentalis Doses First Patient in Phase 3 ASPENOVA Trial for Cyclin E1 Ovarian Cancer
Zentalis Pharmaceuticals has dosed the first patient in its global Phase 3 ASPENOVA trial of azenosertib monotherapy (400mg QD 5:2) versus standard single-agent chemotherapy in approximately 420 Cyclin E1-positive platinum-resistant ovarian cancer patients. The trial will measure progression-free survival to support full FDA approval following the DENALI Phase 2 accelerated pathway.
1. Phase 3 Trial Initiation
Zentalis Pharmaceuticals has dosed the first patient in its global ASPENOVA Phase 3 trial evaluating 400mg QD 5:2 azenosertib monotherapy versus investigator’s choice chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer patients.
2. Trial Design and Endpoints
ASPENOVA will enroll around 420 patients randomized to azenosertib or standard single-agent regimens including paclitaxel, PLD, gemcitabine or topotecan, with progression-free survival as the primary endpoint and overall survival and response rate as key secondary measures.
3. Dual-Track Regulatory Strategy
Zentalis is pursuing accelerated approval through the ongoing DENALI Phase 2 trial, with a topline readout expected by year-end 2026, while ASPENOVA serves as the confirmatory study to satisfy FDA requirements for full approval.
4. Targeted Biomarker Approach
Azenosertib is an oral, first-in-class WEE1 inhibitor designed to exploit Cyclin E1 overexpression, addressing an unmet need in platinum-resistant ovarian cancer patients, where about half exhibit this biomarker and lack approved targeted treatments.