Zentalis Pharmaceuticals, Inc. (ZNTL), Monday announced the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial evaluating azenosertib in Cyclin E1+ platinum-resistant ovarian cancer or PROC.
This marks a significant step in Zentalis's clinical development of azenosertib (ZN-c3), a first-in-class WEE1 inhibitor.
Zentalis said the trial has two parts:
-- Part 2a will confirm the optimal dose with ~30 patients in each of two dose arms (400mg QD 5:2 and 300mg QD 5:2).
-- Part 2b will enroll approximately 70 additional patients at the selected dose from Part 2a, subject to FDA feedback.
The company expects to report topline data from Part 2 by year-end 2026, which could potentially support an accelerated approval depending on FDA review.
"We are excited to continue the clinical development of azenosertib and are proud to take another step forward in addressing the significant unmet need in Cyclin E1+ PROC," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis.
"This trial has the potential to offer a new treatment option for many women diagnosed with Cyclin E1+ PROC."
Earlier data from DENALI Part 1b showed 34.9 percent objective response rate or ORR and 6.3 months median duration of response or mDOR among patients with Cyclin E1+ PROC.
Cyclin E1 overexpression was identified as a predictive biomarker, enabling better patient selection for treatment with azenosertib.
Azenosertib, an oral WEE1 inhibitor, enables cell cycle progression in cancer cells with DNA damage, resulting in mitotic catastrophe and cancer cell death.
Currently, ZNTL is trading at $1.41 down by 1.04 percent on the Nasdaq.
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