Zentalis Pharmaceuticals, Inc. (ZNTL) — Current Report

Key Insights

• Zentalis Pharmaceuticals has selected the 400mg once daily on a 5-days-on, 2-days-off schedule as the optimal monotherapy dose of azenosertib for the ongoing DENALI Phase 2 and confirmatory ASPENOVA Phase 3 clinical trials in patients with Cyclin E1-positive platinum-resistant ovarian cancer.
• The company has expanded the DENALI Part 2 trial to include a new cohort (Part 2c) that will broaden the study population to include patients previously treated with a taxane-containing regimen for platinum-resistant ovarian cancer.
• Zentalis expects to complete enrollment in all cohorts of the DENALI Part 2 trial and provide a topline readout by the end of 2026, with the trial design intended to support accelerated approval pending study outcome and discussions with the FDA.