Azenosertib (ZN-c3) + ZEJULA (Niraparib) - (DENALI)

July 17, 2026: Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) announced two ESMO Congress 2026 presentations (Oct. 23–27, 2026; Madrid) for its investigational WEE1 inhibitor azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). A rapid oral presentation will report overall survival (OS) analysis from DENALI Part 1b (GOG-3066) on Oct. 23, 2026 (Presentation 1242RO). A trial-in-progress poster will outline ASPENOVA, a Phase 3 randomized study of azenosertib monotherapy vs investigator’s choice single-agent chemotherapy (paclitaxel, PLD, gemcitabine, or topotecan) on Oct. 26, 2026 (Presentation 1339TiP).

DENALI (Phase 2, registration-intended; NCT05128825): Part 1b treated PROC patients regardless of Cyclin E1 expression with azenosertib 400 mg QD 5:2. Part 2 is enrolling Cyclin E1-overexpressing PROC patients to potentially support accelerated approval pending positive outcomes and FDA discussions; 400 mg QD 5:2 was selected as the monotherapy dose (300 mg arm discontinued). Parts 2b (up to ~100 patients) and 2c (~40 taxane-pretreated patients) are currently enrolling.

ASPENOVA (Phase 3; ~420 patients): primary endpoint PFS; key secondary endpoints OS and ORR; designed to support full approval and potential accelerated approval conversion based on FDA feedback.