Deaths stop Seattle Genetics trial but company's confidence preserved
US biotech Seattle Genetics (Nasdaq: SGEN) lost around 4% of its stock value on Monday as it announced that it was discontinuing the Phase III CASCADE trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients.
The company took this action following a review of unblinded data and after consultation with the Independent Data Monitoring Committee. A higher rate of deaths, including fatal infections in the vadastuximab talirine-containing arm versus the control arm of the trial, were indicated by the data. The safety concerns do not appear related to hepatotoxicity.
Seattle Genetics is suspending patient enrollment and treatment in all of its vadastuximab talirine clinical trials, including the ongoing Phase I/II clinical studies in frontline high-risk myelodysplastic syndrome.
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