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Seattle Genetics halts trial of vadastuximab talirine for acute myeloid leukemia
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Seattle Genetics discontinued a randomized phase 3 trial designed to evaluate vadastuximab talirine for frontline treatment of elderly patients with acute myeloid leukemia.
Vadastuximab talirine (SGN-CD33A, Seattle Genetics) is a novel investigational antibody–drug conjugate that targets CD33.
Researchers involved with the double blind, placebo-controlled CASCADE trial assessed the efficacy and safety of vadastuximab talirine in combination with the hypomethylating agents azacitidine or decitabine versus the hypomethylating agents alone for treatment of older patients with newly diagnosed AML.
The company discontinued the trial after an independent data monitoring committee reviewed unblinded data. The data showed a higher rate of deaths — including fatal infections — in vadastuximab talirine–treated patients.
“This is a disappointing and unexpected result for the CASCADE trial,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a company-issued press release. “Patient safety is our highest priority, and we will closely review the data and evaluate next steps.”
Seattle Genetics also suspended patient enrollment and treatment in all of its clinical trials that use vadastuximab talirine, including a phase 1/phase2 trial designed to evaluate the agent as frontline therapy for patients with high-risk myelodysplastic syndrome.
The company plans to review data from the study and consult with the FDA to determine future plans for the vadastuximab talirine development program, according to the release.