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Zentalis Pharmaceuticals Announces First Patient Dosed in ASPENOVA Phase 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

ZNTL
  • Zentalis Pharmaceuticals announced that the first patient has been dosed in the global Phase 3 ASPENOVA trial (NCT07546500) evaluating azenosertib for Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
  • The ASPENOVA trial is a randomized, controlled study comparing azenosertib monotherapy to investigator's choice of standard-of-care chemotherapy in approximately 420 patients.
  • Azenosertib is administered at 400mg once daily on a 5-days-on, 2-days-off schedule, a dose selected based on interim analysis from the DENALI Part 2a trial.
  • ASPENOVA serves as the confirmatory study to support full FDA approval, while the ongoing DENALI Phase 2 trial is designed to support an accelerated approval pathway.
  • The primary endpoint for ASPENOVA is progression-free survival, with overall survival and overall response rate as key secondary endpoints.
  • The DENALI Phase 2 trial is expected to provide a topline readout by year-end 2026 to support the dual-track regulatory strategy for azenosertib.
  • Azenosertib is a first-in-class, orally bioavailable WEE1 inhibitor currently granted Fast Track Designation by the FDA for this specific patient population.
  • The trial involves collaboration with The GOG Foundation, ENGOT, and APGOT to address the unmet medical need in patients with Cyclin E1-overexpressing ovarian cancers.
  • Zentalis aims to convert accelerated approval to full approval using data from both the DENALI and ASPENOVA trials.