$APVO (APTEVO THERAPEUTICS) — 8-K: Mipletamig triplet shows 93% clinical benefit rate in TP53-mutated frontline AML

Of 14 evaluable TP53-mutated AML patients treated with mipletamig plus venetoclax and azacitidine, 13 (93%) experienced clinical benefit. Eleven patients achieved CR or CRi (79%), including nine complete remissions. This compares favorably with a published 41% composite remission rate for venetoclax plus azacitidine in treatment-naive patients with poor-risk cytogenetics and TP53-mutated AML. The RAINIER dose optimization trial is expected to be completed by year-end, with regulatory interaction planned for 1H27.

Of 14 evaluable TP53-mutated AML patients treated with mipletamig plus venetoclax and azacitidine, 13 (93%) experienced clinical benefit. Eleven patients achieved CR or CRi (79%), including nine complete remissions. This compares favorably with a published 41% composite remission rate for venetoclax plus azacitidine in treatment-naive patients with poor-risk cytogenetics and TP53-mutated AML. The RAINIER dose optimization trial is expected to be completed by year-end, with regulatory interaction planned for 1H27.