For Zentalis Pharmaceuticals Inc. (ZNTL), 2026 is shaping up to be a pivotal year, with its WEE1 inhibitor Azenosertib moving through late-stage development and multiple clinical and regulatory milestones expected across the program.
The company has completed enrolment in DENALI Part 2a, the dose-confirmation stage of its Phase 2 registration-intent trial evaluating Azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Dose confirmation is expected in the first half of 2026, followed by a topline readout by year-end, which Zentalis believes could support an accelerated approval filing pending FDA feedback.
Cyclin E1-positive platinum-resistant ovarian cancer (PROC) represents a biomarker- defined population with significant unmet need, accounting for roughly half of all PROC cases. These patients typically face limited treatment options and poor outcomes, making targeted approaches a priority area for drug development.
Azenosertib is an investigational, selective, orally bioavailable WEE1 inhibitor designed to disrupt cancer cell cycle regulation and induce mitotic catastrophe. In earlier trial segments, the therapy demonstrated clinically meaningful activity with a manageable safety profile, and Cyclin E1 overexpression emerged as a predictive biomarker for identifying patients most likely to benefit.
Alongside DENALI, Zentalis plans to initiate ASPENOVA, a Phase 3 randomized confirmatory trial comparing Azenosertib with standard-of-care chemotherapy in Cyclin E1-positive PROC. The study is expected to begin in the first half of 2026 and will run concurrently with DENALI Part 2.
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