The US Food and Drug Administration (FDA) has placed a partial hold on three of the clinical studies of Zentalis Pharmaceuticals’ azenosertib, aimed at treating different types of cancer.
The impacted trials are the Phase I ZN-c3-001 dose-escalation study of azenosertib to treat solid tumours, the Phase II ZN-c3-005 (DENALI) trial to treat platinum-resistant ovarian cancer (PROC) and the Phase II ZN-c3-004 (TETON) study in uterine serous carcinoma (USC).
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This decision was taken after two patients in the DENALI study passed away, presumably due to sepsis.
Despite the partial clinical hold, the company confirmed that it is proceeding with the release of topline results from Cohort Ib of the DENALI trial.
In addition, the company anticipates presenting findings from the ZN-c3-001 and Phase I/II ZN-c3-006 (MAMMOTH) studies later in the year.
Further updates on the azenosertib clinical development programme and other data timelines will be communicated following the resolution of the partial clinical hold.
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By GlobalDataA key product candidate of Zentalis, azenosertib (ZN-c3) is a WEE1 inhibitor being assessed for advanced solid tumours and haematologic malignancies.
It is currently under evaluation both as a monotherapy and in combination with other treatments across multiple trials.
In clinical trials to date, azenosertib has demonstrated a good tolerance profile and shown anti-tumour activity as a stand-alone treatment in treating various kinds of tumours.
Zentalis Pharmaceuticals CEO Kimberly Blackwell said: “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.
“Over 500 patients have been treated with azenosertib monotherapy to date and we believe that our data indicate a favourable therapeutic index that could potentially offer meaningful benefits to women facing PROC and USC.
“We have completed enrolment for Cohort Ib of the DENALI study, where we have enrolled more than 100 patients, further demonstrating the support we have seen for having a novel oral therapy like azenosertib.”
