Zentalis Pharmaceuticals (NASDAQ: ZNTL) presented results today from an interim analysis of the DENALI Part 1b study as of a May 22, 2026, data cutoff, including the first overall survival (OS) analysis for azenosertib, at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
In a statement, Julie Eastland, CEO of Zentalis, commented, “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, MD, professor at the University of Pennsylvania Perelman School of Medicine and lead investigator for the DENALI study and The GOG Foundation, added, “The OS 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. The separation in median OS 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.”
