On July 17, 2026 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, reported two presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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"We are pleased that the overall survival results from the DENALI Part 1b study are accepted as a rapid oral presentation at ESMO (Free ESMO Whitepaper)." said Julie Eastland, Chief Executive Officer. "The data will showcase the long-term survival benefits demonstrated by azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer in this study and further support our strategic focus on advancing azenosertib in registration-intended monotherapy trials for this biomarker-selected patient population with high unmet need."

Rapid oral presentation:
Title: "Azenosertib in platinum-resistant ovarian cancer (PROC): overall survival analysis from Part 1b of the DENALI study (GOG-3066)"
Date/Time: Friday, October 23, 2026, 4:15 p.m. – 5:45 p.m. CEST
Presentation Number: 1242RO

Trial-in-progress poster presentation:
Title: "ASPENOVA: A phase 3 study of azenosertib monotherapy versus standard of care chemotherapy in cyclin E1-positive platinum-resistant ovarian cancer (PROC)"
Date/Time: Monday, October 26, 2026, 12:00 p.m. – 12:45 p.m. CEST
Presentation Number: 1339TiP

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2 (5 days once-daily administration of azenosertib, followed by 2 days without azenosertib).

Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2, in total, is designed to support accelerated approval, pending positive study outcomes and further discussions with the FDA. The study design consists of the following parts:

Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.
Part 2c: Broadening study population, which is expected to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment.

(Press release, Zentalis Pharmaceuticals, JUL 17, 2026, View Source [SID1234669298])