Zentalis reports azenosertib ORR ~35% and mDOR 6.3 months in Cyclin E1+ PROC; Part 2 initiation on track for 1H2025

Zentalis Pharmaceuticals, Inc.

Azenosertib demonstrated ORR of 34.9% (15/43) in response-evaluable Cyclin E1+ PROC patients; mDOR 6.3 months (95% CI: 2.7–NE) as of Jan 13, 2025 cutoff.
Cyclin E1 overexpression by IHC identified as predictive biomarker; ~50% of PROC patients overexpress Cyclin E1.
Safety profile consistent; most common TRAEs were GI toxicities and fatigue; 21.6% discontinued due to TRAEs.
Initiation of DENALI Part 2 in 1H 2025 on track; registration-intent topline data expected by year end 2026.
Preclinical data show synergistic antitumor effects of azenosertib combined with microtubule inhibitor-based ADCs.

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