Aptevo Therapeutics presented preliminary results from its ongoing Phase 1b/2 RAINIER study at ASH 2025.
Mipletamig, a novel bispecific CD123 x CD3 molecule, showed high remission rates and a compelling safety profile.
Key findings include 100% CRS-free patients in cohorts 1-3 and a 93% overall response rate.
Key Findings
100% of treated patients remained free of CRS and 93% overall response rate.
CR/CRi Achievements
87% achieved CR/CRi with 73% achieving CR.
MRD Status
60% of MRD evaluable patients achieved MRD negative status.
- Mipletamig's differentiated safety profile highlights its promise in frontline AML.
- The absence of CRS and high remission rates support its potential in combination therapy.
The promising data from the RAINIER study show the potential of Mipletamig in frontline AML treatment, paving the way for further evaluation.