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Zentalis Pharmaceuticals Announces First Patient Dosed in ASPENOVA Phase 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer
Global Phase 3, randomized, controlled trial comparing azenosertib to standard-of-care chemotherapy now enrollingASPENOVA designed as confirmatory study to support DENALI Phase 2 accelerated approval pathway, pending FDA feedback SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian c
About this update from Zentalis Pharmaceuticals, Inc.
SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). "Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and ASPENOVA now enrolling to evaluate azenosertib versus standard-of-care chemotherapy to support full approval, we are executing on a comprehensive development and regulatory strategy designed to bring this therapy to patients as quickly as possible. We are deeply grateful to the patients participating in this important trial and to our collaborators at The GOG Foundation, Inc. (GOG-F), ENGOT, and APGOT for their partnership in advancing this research." "Cyclin E1-overexpressing ovarian cancers are associated with platinum-resistance and poor outcomes, representing a clinical unmet need," said Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the ASPENOVA trial and GOG-F. "This biomarker has yet to be exploited therapeutically and azenosertib, a WEE1 inhibitor, is an oral, targeted treatment that is showing exciting activity in Cyclin E1-overexpressing ovarian cancer (SGO Annual Meeting, 2025). The biomarker-driven approach now being studied in this Phase 3 randomized trial has the potential to identify patients most likely to benefit while sparing them from the inconvenience of intravenous regimens. On behalf of GOG Foundation, we are pleased to collaborate with Zentalis, ENGOT, and APGOT on this important trial for this underserved patient population." ASPENOVA is a randomized, controlled Phase 3 trial designed to confirm the clinical benefit of azenosertib and support full approval as part of Ze...
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