Trials of Vadastuximab Talirine to Resume After FDA Clinical Hold

The FDA lifted its clinical hold on early-stage studies of vadastuximab talirine for AML after halting them in early January following four patient deaths.

Seattle Genetics Inc., the manufacturer of vadastuximab talirine, said the clinical hold was resolved through a comprehensive study evaluating more than 300 patients, and amendments were made to the study protocols to further enhance safety. Two early-stage trials will resume, with plans for a mid-stage trial to begin this year.

Results from a phase Ib study were presented at the 2016 ASH Annual Meeting and suggested that combining standard 7+3 chemotherapy with vadastuximab talirine was safe in patients with newly diagnosed AML.

Seventy-six percent of patients achieved a response, most of which (60%) were complete remissions.

Patients showed no evidence of increased toxicity; 30- and 60-day mortality rates were 0 percent and 7 percent, respectively; and the rates of hematologic AEs were similar to what would be expected with standard chemotherapy alone, according to the researchers.

Source: Reuters, March 6, 2017.