A new study published in The Lancet Oncology suggests that the combination of enasidenib (Idhifa) and azacitidine are well tolerated and offer improved overall response rate (ORR) in recipients with newly-diagnosed IDH2-mutant acute myeloid leukemia (AML) compared with azacitidine monotherapy.
Enasidenib is specifically a small molecule, oral inhibitor of isocitrate dehydrogenase 2 (IDH2) inhibitor. The current standard of care in acute myeloid leukemia is induction together with myeloablative intensive chemotherapy.
For all those recipients who are not chemo eligible, either due to age or due to poor performance status, lower-intensity strategies are used. These include low doses of chemo and the consideration of targeted agents with FLT3 or IDH2 mutations.
The phase 1/2 findings compared azacitidine monotherapy to the experimental addition of azacitidine and enasidenib. The primary end points are dose-limiting toxicities, AEs, ORR, and pharmacokinetics. Secondary end points basically include event-free survival, complete remission, hematologic improvement rate, OS, duration of response, one-year survival, and time to response.
Phase-1 b assessed the efficacy, along with tolerability, and also clinical activity of the addition. During phase-2, the addition was compared head to head with azacitidine monotherapy.
In terms of safety, 91 percent of patients in
the addition group and 81 percent of patients in the monotherapy group
experienced adverse events. The common adverse events included thrombocytopenia,
vomiting, neutropenia, anemia, and nausea.
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