Seattle Genetics cut the trial short on June 16 after a review of study data showed patients treated with the experimental drug were experiencing a higher death rate than the control group.
“This is a disappointing and unexpected result for the … trial. Patient safety is our highest priority, and we will closely review the data and evaluate next steps,” said Clay Siegall, PhD, president and CEO at Seattle Genetics, according to a release. “AML is a devastating disease with a poor prognosis in most patients, and there is a great need for therapeutics against this disease. We thank the patients, caregivers and investigators for their support of this trial.”
The Food and Drug Administration placed a clinical hold on Seattle Genetics’ leukemia drug trial in December 2016 after four participants died. The agency removed the hold in March.
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