Sepsis deaths trigger FDA hold on Zentalis' azenosertib cancer studies
18 Jun 2024
Phase 1Phase 2Clinical Result
Zentalis Pharmaceuticals disclosed that the FDA has placed a partial clinical hold on three monotherapy studies of its lead candidate, the oral WEE1 inhibitor azenosertibWEE1 inhibitor azenosertib (ZN-c3), following two patient deaths presumed to be from sepsis. The news sent company shares sliding more than 45% on Tuesday.
The hold impacts the Phase I dose-escalation study ZN-c3-001 in solid tumours, the Phase II DENALI trial in platinum-resistant ovarian cancer (PROC), and the Phase II TETON study in uterine serous carcinoma. The sepsis cases occurred in the DENALI study.
“Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate,” stated CEO Kimberly Blackwell, adding, “we are working closely with the FDA to resolve this partial clinical hold as quickly as possible.”
Despite the setback, Blackwell remains confident about azenosertib's therapeutic index, noting that over 500 patients have received the WEE1 inhibitorWEE1 inhibitor as monotherapy across various studies. DENALI's Cohort Ib alone enrolled over 100 PROC patients. "We look forward to sharing these results along with overall efficacy and safety data from DENALI Cohort Ib later this year," Blackwell added.
Phase Ib data reported last year showed a confirmed overall response of 50% and median progression-free survival of 7.4 months when azenosertib was combined with paclitaxel in PROC patients. Azenosertib is a potentially first-in-class WEE1 inhibitorWEE1 inhibitor targeting tumours with genomic instability, like PROC and uterine serous carcinoma. By blocking WEE1, Zentalis says its drug causes cancer cells to accumulate DNA damage, resulting in replication stress and apoptosis.
While resolving the clinical hold, Zentalis said it also plans to report Phase I/II data from the MAMMOTH study later this year evaluating azenosertib plus GSK's PARP-blocking drug Zejula (niraparib) in PROC patients. "Zentalis remains committed to… bringing this potentially practice-changing therapy to patients with gynaecological malignancies," the company stated.
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