Aptevo Therapeutics announces results from cohort 1 in frontline AML trial

Aptevo Therapeutics (APVO) announced 100% of patients achieved remission within 30 days, in Cohort 1 of the RAINIER frontline acute myeloid leukemia Phase 1b trial, including two patients who experienced complete remission with minimal residual disease-negative status. The results build on data from the prior trial, in which 100% of frontline patients also achieved remission. Mipletamig, a CD3 x CD123 bispecific antibody, is being investigated as frontline therapy in combination with venetoclax and azacitidine, a current standard of care for AML. These latest results further reinforce mipletamig’s potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving 90 patients.”We are very excited by these Cohort 1 results as they add to an already compelling story that highlights mipletamig’s potential to elevate the frontline AML treatment paradigm. We now have a 100% rate of remission in Cohort 1 of RAINIER. We saw a 100% rate of remission in frontline patients treated with the combination in our completed dose expansion trial. Remarkably, 86% of patients across both trials went into remission within 30 days of receiving their first treatment,” said Marvin White, President and CEO of Aptevo. “It’s also important to note that mipletamig continues to demonstrate a favorable safety and tolerability profile, reinforcing its potential as a transformative addition to the standard of care combination. Cohort 2 enrollment is commencing, marking the next step in the study. We look forward to sharing new results as they become available.”