Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of the RAINIER trial for AML.
No dose-limiting toxicities or cytokine release syndrome observed.
Mipletamig shows consistently favorable safety and tolerability.
Efficacy and Market Opportunity
100% remission rate achieved at the highest dose level, potentially redefining frontline treatment for AML patients unfit for intensive chemotherapy.
Safety
Clean safety profile with no dose-limiting toxicities observed across Cohort 3 and previous cohorts, reinforcing drug's use alongside venetoclax and azacitidine.
Next Steps
Cohort 3 enrollment complete, actively enrolling patients for Cohort 4, with anticipation of presenting findings at a major medical conference in Q4.
- Mipletamig's performance in Cohort 3 sets higher expectations for frontline AML therapy.
- The drug's efficacy and safety profile position Aptevo to compete in the high-value AML market.
- Mipletamig's potential to smoothly integrate into the standard of care highlights its significance in AML treatment.
The exceptional results in Cohort 3 underscore the transformative potential of mipletamig in improving outcomes for AML patients, setting a new standard for frontline therapy.