The phase 3 CASCADE trial evaluating vadastuximab talirine (SGN-CD33A) plus chemotherapy among patients with acute myeloid leukemia (AML) was discontinued by Seattle Genetics Inc due to a higher rate of deaths compared with chemotherapy alone.
Vadastuximab talirine is an antibody-drug conjugate targeted to CD33, which is expressed on most AML and myelodysplastic syndrome (MDS) blast cells.
The CASCADE trial (ClinicalTrials.gov Identifier: NCT02785900) is a randomized, double-blind study that treated older patients with AML with azacitidine or decitabine compared with plus vadastuximab talirine plus or placebo.
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Seattle Genetics decided to halt the study following review of unblinded data on June 16, 2017 by the Independent Data Monitoring committee.
The data showed a higher rate of death, including fatal infections, in the vadastuximab talirine arm compared with the chemotherapy-only arm. Hepatotoxicity, however, was not associated with the deaths.
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Patient enrollment and treatment in all vadastuximab talirine clinical trials, including a phase 1b trial in myelodysplastic syndrome, were suspended.
The data will be reviewed in consult with the US Food and Drug Administration to determine next steps.
Reference
- Seattle genetics discontinues phase 3 CASCADE trial of vadastuximab talirine (SGN-CD33A) in frontline acute myeloid leukemia [news release]. Bothell, WA: Seattle Genetics; June 19, 2017. http://investor.seattlegenetics.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2281531. Accessed June 19, 2017.
