What changed
Ten of 47 evaluable frontline AML patients (21%) treated with mipletamig plus venetoclax and azacitidine proceeded to allogeneic stem cell transplant, including nine from the ongoing Phase 1b RAINIER trial and one from a completed dose expansion trial. The patients were initially deemed unfit for intensive induction chemotherapy. Aptevo noted that in the pivotal Phase 3 VIALE-A trial, three of 286 patients (0.7%) receiving venetoclax and azacitidine alone subsequently underwent stem cell transplant, though cross-trial comparisons are limited. Aptevo expects RAINIER dose optimization to conclude by year-end, with FDA interaction and initiation of a Phase 2 trial anticipated in the first half of 2027.