Photo Credit: Nemes Laszlo
The following is a summary of “Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia,” published in the February 2024 issue of Hematology by Pratz et al.
Patients with unsuitable acute myeloid leukemia (AML) for chemotherapy can be treated with Venetoclax-azacitidine based on interim OS analysis of the VIALE-A study.
Researchers conducted a prospective study to evaluate the survival benefit and long-term outcomes of venetoclax-azacitidine in patients with AML ineligible for intensive chemotherapy.
They randomized all the patients into a 2:1 cohort to receive venetoclax-azacitidine or placebo-azacitidine. The primary endpoint of this study was to assess OS, and the secondary endpoint was complete remission with/without blood count recovery (CR/CRi).
The results analyzed a total of 431 patients who were enrolled to receive either venetoclax-azacitidine (286) or placebo-azacitidine (145). With a follow-up of 43.2 months, venetoclax-azacitidine showed a median OS of 14.7 months (95% CI, 12.1-18.7) compared to 9.6 months (95% CI, 7.4–12.7) with placebo-azacitidine (HR 0.58 [95% CI, 0.47-0.72], P<0.001). The 24-month OS rate of Venetoclax-azacitidine was estimated to be 37.5%, whereas placebo-azacitidine was estimated to be 16.9%. Median OS was reached for patients with IDH1/2 mutations and measurable residual disease responses. The CR/CRi rate was consistent with the interim analysis. The trial also saw hematologic and gastrointestinal adverse events commonly, including thrombocytopenia (47% and 42%) and neutropenia (43% and 29%).
Investigators concluded that the long-term efficacy and safety findings declared venetoclax-azacitidine an enhanced standard of care for patients with AML ineligible for intensive chemotherapy.