Aptevo Therapeutics Inc. 8K

Aptevo Therapeutics reported encouraging early RAINIER trial data showing a 93% clinical benefit rate for mipletamig plus venetoclax and azacitidine in frontline TP53‑mutated AML, with dose optimization expected to complete by year-end and regulatory discussions planned for 1H27.

Aptevo Therapeutics Inc. announced new clinical data from its RAINIER trial showing a 93% clinical benefit rate and a 79% complete remission or complete remission with incomplete hematologic recovery rate for its lead drug candidate mipletamig when used in combination with venetoclax and azacitidine in 14 evaluable frontline TP53‑mutated acute myeloid leukemia patients, a difficult-to-treat population that historically responds poorly to therapy. The company highlighted that these results compare favorably to published outcomes for venetoclax plus azacitidine alone, described mipletamig’s CD123-targeting, T cell–engaging mechanism and design features intended to mitigate cytokine release syndrome, and provided an update that the dose optimization phase of the RAINIER Phase 1b/2 trial is expected to complete by year-end with planned regulatory interactions in the first half of 2027, while also outlining broader pipeline activities including trispecific candidates and a radiopharmaceutical collaboration with Niowave.

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1671584

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8K

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sec

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0001193125-26-381098

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6