Mipletamig Combo Delivers 86% Benefit Rate, Zero CRS in 28 AML Patients
Aptevo’s mipletamig with venetoclax and azacitidine achieved an 86% clinical benefit rate in 28 frontline AML patients, including a 61% CR rate, with zero cases of cytokine release syndrome. Among responders, 55% reached MRD-negative status and 35% carried high-risk TP53 mutations, underscoring robust efficacy and safety.
1. Interim Clinical Results
In 28 evaluable frontline AML patients, mipletamig combined with venetoclax and azacitidine achieved an 86% clinical benefit rate, comprising a 79% CR/CRi rate and a 61% complete remission rate.
2. Safety and MRD Outcomes
No patients experienced cytokine release syndrome, and 55% of those achieving CR/CRi reached measurable residual disease-negative status, indicating deep and durable responses.
3. Transplant Outcomes
Four patients treated to date proceeded to allogeneic stem cell transplant, a rare achievement in older or unfit frontline AML populations and a key indicator of potential long-term benefit.
4. RAINIER Trial Design
RAINIER is a Phase 1b/2 multi-center, open-label study enrolling newly diagnosed AML patients ineligible for intensive chemotherapy, using 28-day treatment cycles across multiple sequential dose cohorts.