Zentalis Selects 400mg QD 5:2 Dose After Superior DENALI Part 2a Results
Zentalis selected 400mg QD 5:2 azenosertib monotherapy dose for Cyclin E1-positive platinum-resistant ovarian cancer after DENALI Part 2a showed superior response to 300mg with similar safety. The dose will power DENALI Phase 2 and ASPENOVA Phase 3 trials and target a Part 2 topline readout by year-end 2026.
1. Dose Selection and Interim Data
A prespecified interim analysis of DENALI Part 2a demonstrated a clearly differentiated response rate at 400mg QD 5:2 versus 300mg QD 5:2, with both dose groups showing comparable safety profiles and reduced discontinuation due to adverse events. Based on these data, Zentalis chose 400mg QD 5:2 as the optimal monotherapy dose for Cyclin E1-positive platinum-resistant ovarian cancer.
2. Trial Advancement and Timeline
The 400mg QD 5:2 dose will be carried forward into the registration-intended DENALI Phase 2 trial and the confirmatory ASPENOVA Phase 3 trial, including an expanded Part 2c cohort for taxane-pretreated patients. Zentalis expects to complete enrollment across all DENALI Part 2 cohorts and deliver a topline readout by year-end 2026.
3. Commercial Preparedness and Future Plans
In parallel with late-stage development, Zentalis is scaling manufacturing capacity, building commercial capabilities and advancing a companion diagnostic assay. The company also plans to explore azenosertib’s use in first-line maintenance and combination regimens across additional tumor types pending regulatory progress.