Zentalis Pharmaceuticals Announces First Overall Survival Data for Azenosertib from DENALI Part 1b Published in ESMO Congress 2026 Abstract
Key Highlights
- ➤Cyclin E1-positive patients achieved median overall survival of 15.8 months
- ➤Cyclin E1-negative patients achieved median overall survival of 7.5 months
- ➤No new safety signals observed in interim DENALI Part 1b analysis
- ➤ASPENOVA Phase 3 trial designed to enroll approximately 420 patients
- ➤DENALI Part 2b enrollment complete; Part 2c currently enrolling taxane-treated patients
* Median overall survival of 15.8 months in Cyclin E1-positive platinum-resistant ovarian cancer patients treated with azenosertib monotherapy * Data to be presented as a rapid oral presentation at ESMO Congress 2026 on October 23, 2026 SAN DIEGO, Oct. 18, 2026 (GLOBE NEWSWIRE) -- Zentalis(®) Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that overall survival (OS) data from an interim analysis of the DENALI Part 1b study (GOG-3066) have been published in the abstract for the upcoming rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026.
The published abstract reports results for OS, a secondary endpoint of DENALI Part 1b in patients with platinum-resistant ovarian cancer (PROC), from an interim analysis. As of the September 2, 2025 data cutoff: * In the Cyclin E1-positive subgroup (n=48): median OS of 15.8 months (95% CI, 8.7–17.8); * In the Cyclin E1-negative subgroup (n=46): median OS of 7.5 months (95% CI, 5.8–12.3); * No new safety signals were observed. DENALI Part 1b enrolled 102 patients with PROC regardless of Cyclin E1 protein expression who had received between one and five prior lines of therapy, with prior bevacizumab required. The primary endpoint was objective response rate; secondary endpoints included duration of response, progression-free survival, OS and safety. Cyclin E1 status was retrospectively determined by immunohistochemistry using a proprietary cutoff, with 94 patients evaluable (Cyclin E1-positive: n=48; Cyclin E1-negative: n=46).
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