Seattle Genetics discontinues Phase III trial of vadastuximab talirine on safety signal

Seattle Genetics Inc. (NASDAQ:SGEN) discontinued the Phase III CASCADE trial of vadastuximab talirine (33A, SGN-CD33A) to treat acute myelogenous leukemia (AML) after an IDMC’s analysis showed a higher rate of deaths, including fatal infections, in patients treated with vadastuximab talirine vs. the control arm. The company plans to discuss next steps with FDA.

The double-blind, placebo-controlled, international trial compared vadastuximab talirine plus a hypomethylating agent (HMA) vs. an HMA alone in about 540 older patients with newly diagnosed AML. The co-primary endpoints were overall survival (OS) and composite complete remission rate. Secondary endpoints included minimal residual disease (MRD)-negative composite complete remission rate, event-free survival (EFS), leukemia-free survival (LFS), duration of remission, safety and 30- and 60-day mortality rates...