Seattle Genetics, Inc., announced the discontinuation of the phase III CASCADE trial of vadastuximab talirine (also known as SGN-CD33A) in older patients with newly diagnosed with acute myeloid leukemia (AML) amid rising concerns about patient deaths. It is also suspending patient enrollment and treatment in all vadastuximab talirine clinical trials.
The manufacturer reached the decision after a review of unblinded data from the randomized, double-blind, placebo-controlled CASCADE study and consultation with the Independent Data Monitoring Committee. Patients assigned to receive vadastuximab talirine in combination with hypomethylating agents (HMAs; azacitidine or decitabine) had higher rates of death (including fatal infections) than those in the control arm (in which patients received only HMAs).
The drug’s manufacturer also noted that no new deaths appeared to be associated with hepatotoxicity, an AE linked to the four patient deaths that led to a clinical hold in December 2016. The hold was lifted in March 2017.
Calling the results “disappointing and unexpected,” the manufacturer intends to consult with the FDA to determine future plans for the drug.
Source: Seattle Genetics press release, June 19, 2017.