Acute myeloid leukemia (AML)
APVOAptevo TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Phase 1/2 data readout for Mipletamig (APVO436) +/- Venetoclax + Azacitidine in Acute myeloid leukemia (AML). The expected timing is based on the latest available company guidance and may change.
RAINIER trial. 8/13/24- Initiated Ph1b/2 dose optimization trial. 6/18/25- New data in frontline AML. 9/16/25- 100% remission rate in Cohort 3 reported. Cohort 4 enrolling. Presentation at major medical conference in Q4 2025. 11/06/25:- Across two trials, 89% remission in frontline AML; no CRS observed so far. 12/09/25:- RAINIER Ph1b/2 ASH 2025 poster showed 93% ORR, 87% CR/CRi, no CRS; enrollment ongoing. 03/26/26:- Updated interim RAINIER data: 86% benefit, 79% CR/CRi, 61% CR, 55% MRD-negative; no CRS; four transplants. 05/06/26:- New RAINIER Cohort 5 data: 81% CR/CRi. Complete Ph1b dose optimization and select RP2D in 2026. 05/13/26:- RAINIER on track for completion and Ph2 dose selection by year-end 2026. Updated Cohort 5: 81% CR/CRi, no CRS. Added RAINIER data: 87% clinical benefit, 81% CR/CRi, 65% CR, 52% MRD-negative, no CRS. 08/14/26:- Updated RAINIER data showed 87% clinical benefit and 81% remission. Final dose optimization will complete and RP2D will be selected by year-end 2026. Phase 2 regulatory interaction is expected in Q1 2027.
Verification
Confirm timing and program details against the company announcement or filing.