FDA places partial clinical hold on Ph 1 ZN-c3-001 in solid tumors, Ph 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and Ph 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC) of azenosertib
“Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate. We are working closely with the FDA to resolve this partial clinical hold as quickly as possible,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. “Over 500 patients have been treated with azenosertib monotherapy to date, and we believe that our data indicate a favorable therapeutic index that could potentially offer meaningful benefits to women facing PROC and USC. 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. We look forward to sharing these results along with overall efficacy and safety data from DENALI Cohort 1b later this year.”
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