Biopharmaceutical company Zentalis Pharmaceuticals, Inc. (ZNTL) announced Tuesday that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on three studies of azenosertib.
The Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC) were put on hold.
This action follows two recent deaths due to presumed sepsis in the DENALI study.
In addition to sharing topline results of Cohort 1b of DENALI, the Company remains on track to present results from the ZN-c3-001 and Phase 1/2 ZN-c3-006 (MAMMOTH) studies later this year.
Zentalis said it remains committed to the azenosertib development program and bringing this potentially practice-changing therapy to patients with gynecological malignancies.
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