Aptevo Reports Mipletamig Combination Therapy Enabled 21% of Frontline AML Patients to Advance to Potentially Curative Stem Cell Transplant
Key Highlights
- ➤10 of 47 frontline AML patients, or 21%, reached allogeneic stem cell transplant
- ➤VEN+AZA historical comparator: 3 of 286 patients, or 0.7%, underwent transplant
- ➤RAINIER Phase 1b/2 dosing work expected complete by year-end 2026
- ➤Aptevo plans regulatory discussions on RAINIER next steps in first half of 2027
Expert Statements
Dirk Huebner, M.D., Chief Medical Officer of Aptevo
“Each subset analysis helps us better understand the potential of mipletamig in frontline AML. Our previously reported TP53 findings were particularly encouraging given the historically poor outcomes associated with that mutation. Now, we are seeing ten patients advance to stem cell transplant, a treatment that can offer AML patients the possibility of long-term remission or cure. These observations add another important dimension to the clinical activity we have reported and support continued evaluation of the mipletamig triplet.”
SEATTLE, WA / ACCESS Newswire / October 26, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, today announced that ten patients with newly diagnosed acute myeloid leukemia (AML) have advanced to allogeneic stem cell transplant following treatment with mipletamig in combination with venetoclax and azacitidine. Stem cell transplant uses donor cells to replace a patient's blood-forming stem cells and can offer eligible patients the possibility of long-term remission or cure.
Notably, ten of 47 (21%) evaluable frontline patients treated with mipletamig in combination with venetoclax and azacitidine (VEN+AZA) proceeded to allogeneic stem cell transplantation, a potentially curative treatment option. This includes nine patients from the ongoing Phase 1b RAINIER trial and one patient from the previously completed dose expansion trial. This finding is particularly encouraging in a patient population initially deemed unfit for intensive induction chemotherapy, where advanced age, underlying health conditions and other factors can limit treatment options. The ability of these patients to proceed to transplant provides an additional encouraging indication of mipletamig's clinical activity in combination with the current standard of care.
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