On Thursday, Aptevo Therapeutics APVO introduced two extra frontline Acute Myeloid Leukemia (AML) sufferers have achieved remission inside 30 days of therapy within the RAINIER dose optimization trial of mipletamig together with commonplace of look after sufferers unfit for intensive chemotherapy.
9 of 10 frontline sufferers throughout two trials achieved remission when receiving the triplet mixture of mipletamig + venetoclax + azacitidine (ven/aza).
Notably, no cytokine launch syndrome (CRS) has been reported within the RAINIER trial thus far.
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The information builds on beforehand reported favorable outcomes from RAINIER’s Cohort 1 and the finished dose enlargement trial the place 100% of frontline sufferers achieved remission.
Along with the addition of those interim Cohort 2 outcomes, mipletamig has achieved a compelling total remission charge of 90% amongst frontline sufferers, outperforming the doublet remission charge from a venetoclax + azacitidine-only research of 66%.
Moreover, the frontline affected person triplet remedy full remission (CR) charge of 70% outperforms the CR charge from a venetoclax + azacitidine solely research of 36% (Viale-A Pivotal trial).
So far, all RAINIER sufferers who achieved remission stay in remission.
Cohort 2 will embody six sufferers dosed on the 18mcg stage, the identical dose utilized in mixture with ven/aza within the accomplished enlargement trial.
Three sufferers evaluable for efficacy achieved the next outcomes:
- Two sufferers achieved remission inside 30 days of being dosed.
- One affected person progressed after the primary cycle and handed away for causes unrelated to review medicine.
- Cohort 2 enrollment is nearing completion.
In December 2024, Aptevo Therapeutics introduced that 100% of sufferers achieved remission inside 30 days in Cohort 1 of the RAINIER frontline acute myeloid leukemia (AML) Section 1b trial, together with two sufferers who skilled full remission with minimal residual illness (MRD)-negative standing (100% elimination of most cancers cells).
Value Motion: APVO inventory is 2.66% at $2.70 on the final examine Thursday.
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