Aptevo: 10 newly diagnosed AML patients on mipletamig regimen advance to stem cell transplant
Aptevo reported that ten patients with newly diagnosed acute myeloid leukemia treated with mipletamig plus venetoclax and azacitidine have advanced to allogeneic stem cell transplant. The company said the data is a clinical update from its Phase 1b RAINIER trial and one earlier dose expansion trial, and it does not include any financial results or guidance.
Key points
- Ten of 47 (21%) evaluable frontline patients treated with mipletamig plus venetoclax and azacitidine proceeded to transplant, including nine from RAINIER and one from the prior dose expansion trial.
- The company cited the Phase 3 VIALE-A trial, in which three of 286 patients (0.7%) receiving venetoclax and azacitidine alone later underwent transplant, and noted that cross-trial comparisons have limits.
- Aptevo expects to complete RAINIER dose optimization by year-end 2026 and discuss next steps with regulators in the first half of 2027.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 26, 2026.
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