“Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate,” Zentalis CEO Kimberly Blackwell, M.D., said in the June 18 release. “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 as a monotherapy across various trials to date, Blackwell pointed out, with the DENALI trial alone enrolling over 100 patients in cohort 1b.
“We look forward to sharing these results along with overall efficacy and safety data from DENALI cohort 1b later this year,” the CEO added.
Azenosertib is Zentalis’ only clinical-stage asset. The biotech’s shares plummeted 30% in the wake of the news, dropping to $5.85 in pre-market trading on Tuesday morning from a Monday closing price of $8.39.
The company is still on track to report topline results from the phase 1 solid tumor trial as well as a phase 1/2 trial of azenosertib in combination with GSK’s Zejula for ovarian cancer later in 2024, according to the release.
“Zentalis remains committed to the azenosertib development program and bringing this potentially practice-changing therapy to patients with gynecological malignancies,” the biotech said in the release.
The company previously shared data at last year’s ASCO conference from a phase 1b study of azenosertib plus the chemotherapy paclitaxel in ovarian cancer that demonstrated an overall response rate of 50%. The biotech said at the time that the data were enough to begin preparations for a phase 3 study comparing azenosertib with either carboplatin or paclitaxel in patients with Cyclin E1+status and with platinum-sensitive ovarian cancer.
The original plan was to launch a late-stage trial off the back off the data in the first quarter of 2024, although this timeline has since been pushed back to 2025.
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