Clinical TrialMay 6, 2026, 04:16 PM
Aptevo RAINIER AML Trial Shows 87% Clinical Benefit, 81% Remission
AI Summary
Aptevo Therapeutics reported new clinical results from its RAINIER frontline acute myeloid leukemia (AML) trial, demonstrating an 87% clinical benefit rate and an 81% remission rate across 31 evaluable patients. These results significantly outperform historical benchmarks, showing strong clinical activity and a favorable safety profile. The company is on track to complete the Phase 1b dose-optimization trial and select the recommended Phase 2 dose in 2026, with the program now entering its final stage of dose optimization.
Key Highlights
- Aptevo's RAINIER trial showed an 87% clinical benefit rate (CR/CRi/PR) in 31 evaluable frontline AML patients.
- The trial achieved an 81% remission rate (CR/CRi) and a 65% complete remission (CR).
- These results substantially outperform the historical benchmark of 66.4% composite CR/CRi and 37% CR.
- 52% of patients achieving CR/CRi had blast reductions to the measurable residual disease-negative level.
- 36% of remissions occurred in patients with the high-risk TP53 genetic mutation.
- No cytokine release syndrome was reported, and 6 patients proceeded to allogeneic stem cell transplant.
- The Phase 1b dose-optimization trial is on track for completion and Phase 2 dose selection in 2026.