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Aptevo Reports 93% Clinical Benefit Rate with Mipletamig Triplet in Difficult-to-Treat TP53-Mutated Frontline AML

$APVOPress releaseSep 3, 2026, 8:05 AM ETRead the release

Aptevo Therapeutics reported a 93% clinical benefit rate for its lead candidate mipletamig in combination with venetoclax and azacitidine among 14 evaluable frontline acute myeloid leukemia patients with TP53 mutations, one of the most difficult-to-treat forms of AML. Thirteen of the 14 patients experienced clinical benefit, with 11 achieving CR or CRi (79%) including nine complete remissions — nearly double the published 41% composite remission rate for venetoclax plus azacitidine in this historically poor-responding population.

Key figures

Drug Name
mipletamig
Phase Of Trial
Phase 1b/2
Trial name
RAINIER
Cr cri rate
79%
Evaluable patients
14
Complete remissions
9
Clinical benefit rate
93%
Dose optimization completion
year-end 2026
Regulatory interaction timing
1H27
Patients with clinical benefit
13
Benchmark ven aza remission rate
41%

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