Zentalis Pharmaceuticals, Inc. (ZNTL) announced that 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) has been selected as the pivotal monotherapy dose of Azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
The decision follows a prespecified interim analysis from the ongoing DENALI Part 2a trial, which showed a clearly differentiated response rate at 400mg compared to 300mg, with comparable safety profiles.
Clinical Significance
Azenosertib is a first-in-class, oral WEE1 inhibitor designed to target Cyclin E1-positive PROC, a biomarker-selected population that represents about half of patients with this difficult-to-treat cancer. Current therapies rely on intravenous chemotherapy, while Azenosertib offers the potential for a more convenient oral option.
Trial Progress
•DENALI Part 2a: Interim analysis confirmed 400mg QD 5:2 as the optimal dose, with lower discontinuation rates and no treatment-related deaths.
•DENALI Part 2b: Enrollment expansion at the selected dose is ongoing, targeting approximately 100 patients.
•DENALI Part 2c: A new cohort will include patients previously treated with taxane-containing regimens, with enrolment expected to begin in Q2 2026.
•ASPENOVA Phase 3: A randomized, confirmatory trial enrolling approximately 420 patients will compare Azenosertib monotherapy at 400 mg QD 5:2 against standard-of-care chemotherapy.
Regulatory Pathway
Data from DENALI Part 2 are intended to support a potential accelerated approval pathway, with topline results expected by year-end 2026. Azenosertib has already received Fast Track Designation from the FDA for Cyclin E1-positive PROC.
CEO's Perspective
Julie Eastland, CEO of Zentalis, said: "Selecting the pivotal monotherapy dose for Azenosertib is a key inflection point that supports our registration-intended path. We are initiating launch preparedness by adding commercial capabilities and advancing companion diagnostic development."
ZNTL has traded between $1.01 and $3.95 over the past year. The stock is currently trading at $3.20, up 16.18%.
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