Seattle Genetics has discontinued its phase III CASCADE clinical trial of front-line vadastuximab talirine (SGN-CD33A) in older acute myeloid leukemia (AML) patients.
The phase III CASCADE clinical trial is a randomized, double-blind, placebo-controlled study evaluating vadastuximab talirine in combination with the hypomethylating agents azacitidine or decitabine compared to a hypomethylating agent alone in older patients with newly diagnosed AML. Vadastuximab talirine is a novel investigational antibody-drug conjugate targeted to CD33 utilizing Seattle Genetics’ proprietary technology. CD33 is expressed on most AML and myelodysplastic syndrome (MDS) blast cells.
The company took this action following consultation with the independent data-monitoring committee and after reviewing unblinded data on June 16, 2017. The data indicated a higher rate of deaths, including fatal infections in the vadastuximab talirine–containing arm vs the control arm of the trial. Based on available data, the safety concerns in this trial 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 trial in front-line high-risk MDS.
“This is a disappointing and unexpected result for the CASCADE trial. Patient safety is our highest priority, and we will closely review the data and evaluate next steps. 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,” said Clay Siegall, PhD, President and Chief Executive Officer at Seattle Genetics.
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