Clinical Hold on Zentalis Drug After 2 Deaths

FDA has placed a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib studies, including a Phase 1 (ZN-c3-001) dose-escalation study in solid tumors, a Phase 2 (DENALI) study in platinum-resistant ovarian cancer, and a Phase 2 (TETON) study in uterine serous carcinoma. The action is in response to two recent deaths due to presumed sepsis reported in the DENALI study.

“We are working closely with the FDA to resolve this partial clinical hold as quickly as possible,” a company release says. It says over 500 patients have been treated with azenosertib monotherapy to date. “We have completed enrollment for Cohort 1b of the DENALI study, where we’ve enrolled more than a hundred patients, further demonstrating the support we’ve seen for having a novel oral therapy like azenosertib,” it adds. “We look forward to sharing these results along with overall efficacy and safety data from DENALI Cohort 1b later this year.”