Zentalis Pharmaceuticals has reported interim overall survival results from the DENALI Part 1b study (GOG-3066) evaluating azenosertib in patients with platinum-resistant ovarian cancer.
Patients in the Cyclin E1-positive cohort achieved a median overall survival of 15.8 months. Those in the Cyclin E1-negative group recorded a median overall survival of 7.5 months.
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Investigators identified no new safety signals during the interim assessment.
The study abstract stated that median survival in the Cyclin E1-positive population compared favourably with historical single-agent chemotherapy benchmarks, identifying Cyclin E1 as a predictive biomarker for drug response.
DENALI Part 1b evaluated 102 participants who had undergone between one and five previous lines of treatment, including mandatory exposure to bevacizumab.
Every participant received 400mg of azenosertib once daily on a five-days-on, two-days-off timetable regardless of protein status. Retrospective immunohistochemistry testing evaluated 94 patients, confirming 48 positive cases and 46 negative cases.
The primary endpoint for Part 1b was objective response rate, alongside secondary measures covering safety, progression-free survival, overall survival, and response duration.
Azenosertib is an investigational, orally bioavailable inhibitor of WEE1 that regulates cell cycle checkpoints to trigger mitotic catastrophe in tumour cells.
Around half of all patients with platinum-resistant ovarian cancer express Cyclin E1 protein overexpression, a group that currently lacks approved targeted options.
The ongoing registration-intended DENALI programme continues across three subsequent segments. Part 2a assessed 300mg and 400mg daily doses across around 30 participants per arm before selecting the 400mg regimen.
Enrolment for Part 2b has finished at roughly 100 participants, while Part 2c is currently recruiting around 40 taxane-pretreated individuals.
Zentalis is also progressing Aspenova, a randomised Phase III confirmatory study designed to enrol roughly 420 patients to compare 400mg azenosertib against investigator-selected chemotherapy, including gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or topotecan.
