Zentalis Pharmaceuticals Announces Meaningful Median Overall Survival Data in Cyclin E1-Positive Platinum-Resistant Ovarian Cancer from DENALI Part 1b to be Presented at the ESMO Congress 2026
Key Highlights
- ➤Cyclin E1-positive patients posted median overall survival of 15.9 months
- ➤Cyclin E1-negative patients posted median overall survival of 7.5 months
- ➤Cyclin E1-positive patients recorded 33.3% overall response rate
- ➤Median relative dose intensity reached 84.6% despite dose modifications
- ➤ASPENOVA Phase 3 trial is expected to enroll approximately 420 patients
Expert Statements
Julie Eastland, Chief Executive Officer of Zentalis Pharmaceuticals
“These data continue to build the body of evidence supporting azenosertib as a potential treatment in Cyclin E1-positive platinum-resistant ovarian cancer, underpinning our development approach through the ongoing registration-intended DENALI Part 2 and ASPENOVA Phase 3 confirmatory trials. For patients with Cyclin E1-positive PROC who have limited effective treatment options, we are working to deliver something that has not existed — a targeted, oral treatment that offers more convenience and choice,”
Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the DENALI study and The GOG Foundation, Inc. (GOG-F)
“The overall survival results from DENALI Part 1b are particularly meaningful given the poor prognosis associated with Cyclin E1-positive tumors and the heavily pretreated nature of this trial patient population.”
Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the DENALI study and The GOG Foundation, Inc. (GOG-F)
“The separation in median overall survival between Cyclin E1-positive and Cyclin E1-negative patients — 15.9 months versus 7.5 months — strongly supports Cyclin E1 protein expression as a clinically relevant and predictive patient selection biomarker for azenosertib. Taken together with the response data and manageable adverse events, these findings provide important evidence supporting continued development of azenosertib in this biomarker-selected population with high unmet need.”
* Median overall survival of 15.9 months in Cyclin E1-positive PROC, with 1–5 prior lines of therapy; safety profile in DENALI Part 1b was consistent with prior reporting * Median relative dose intensity was 84.6%, confirming high overall exposure to azenosertib * DENALI Part 1b interim analysis adds to the body of evidence supporting Cyclin E1 protein expression as a predictive biomarker for azenosertib in platinum-resistant ovarian cancer SAN DIEGO, Oct. 23, 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 presented results from an interim analysis of the DENALI Part 1b study (GOG-3066) as of a May 22, 2026 data cutoff, including the first overall survival analysis for azenosertib, at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
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