Azenosertib

Zentalis Pharmaceuticals announces FDA removal of partial clinical hold on azenosertib studies, allowing resumption of patient enrollment. Azenosertib, an orally bioavailable WEE1 inhibitor, targets gynecologic malignancies and is being evaluated in ovarian cancer and other tumor types. Zentalis plans to present monotherapy data and expects to meet 2024 data guidance. The company remains focused on advancing azenosertib and exploring protein degraders for high genomic instability tumors.

The FDA has lifted the partial clinical hold on studies evaluating the WEE1 inhibitor azenosertib in advanced solid tumors. The hold was initially placed on the phase 1 ZN-c3-001 trial, phase 2 DENALI trial for platinum-resistant ovarian cancer, and phase 2 TETON trial for uterine serous carcinoma due to 2 deaths from presumed sepsis in the DENALI trial. After reviewing Zentalis Pharmaceuticals' complete response package, the FDA allowed the studies to resume without changes to the clinical development plan.

FDA lifts partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing resumption of enrollment in ongoing clinical trials without changes to the development plan. Zentalis remains confident in azenosertib's therapeutic potential for gynecologic malignancies and plans to present monotherapy data later this year.