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Zentalis Presents Promising Azenosertib Data and Outlines Registration Plans for Cyclin E1+ PROC

Zentalis reports positive azenosertib clinical data in Cyclin E1+ platinum-resistant ovarian cancer, paving the way for potential FDA approval.

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  • Jan 30, 2025

  • Mrudula Kulkarni

Zentalis Presents Promising Azenosertib Data and Outlines Registration Plans for Cyclin E1+ PROC

Zentalis Pharmaceuticals (Nasdaq: ZNTL) has unveiled updated clinical data for its WEE1 inhibitor, azenosertib, across multiple studies, including ZN-c3-001, MAMMOTH, and DENALI. The data highlights significant response rates in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC), a population with high unmet medical needs.

Chief Medical Officer Dr. Ingmar Bruns emphasized that azenosertib monotherapy at the 400mg QD 5:2 intermittent dose demonstrated a median duration of response of approximately 5.5 months, with patients remaining on therapy. With over 350 patients treated at clinically active doses, the drug maintains a well-characterized safety profile.

CEO Julie Eastland underscored the substantial therapeutic and commercial potential, noting that Cyclin E1+ patients represent about 50% of PROC cases. She highlighted that DENALI Part 2, if successful, could support accelerated FDA approval. Zentalis’ recent corporate restructuring has also extended its cash runway into late 2027, ensuring financial stability for continued development.

With these advancements, Zentalis is strategically positioned to bring azenosertib to market, offering new hope for patients with treatment-resistant ovarian cancer.

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