Zentalis Pharmaceuticals, Inc. (ZNTL), a biopharmaceutical company, announced on Tuesday that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on three studies involving their drug, azenosertib.
The affected studies include the Phase 1 dose-escalation study ZN-c3-001 in solid tumors, the Phase 2 study ZN-c3-005 (DENALI) in platinum-resistant ovarian cancer (PROC), and the Phase 2 study ZN-c3-004 (TETON) in uterine serous carcinoma (USC).
This decision follows two recent fatalities attributed to presumed sepsis within the DENALI study.
Despite the hold, Zentalis intends to share topline results from Cohort 1b of the DENALI study and is on schedule to present findings from the ZN-c3-001 and Phase 1/2 ZN-c3-006 (MAMMOTH) studies later this year.
Zentalis emphasizes its commitment to the development of azenosertib, aiming to provide this potentially transformative therapy to patients with gynecological cancers.
