Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia

• Autoři: PRATZ Keith W; JONAS Brian A; PULLARKAT Vinod; THIRMAN Michael J; GARCIA Jacqueline S; DOEHNER Hartmut; RECHER Christian; FIEDLER Walter; YAMAMOTO Kazuhito; WANG Jianxiang; YOON Sung-Soo; WOLACH Ofir; YEH Su-Peng; LEBER Brian; ESTEVE Jordi; MAYER Jiří; PORKKA Kimmo; ILLES Arpad; LEMOLI Roberto M; TURGUT Mehmet; KU Grace; MILLER Catherine; ZHOU Ying; ZHANG Meng; CHYLA Brenda; POTLURI Jalaja; DINARDO Courtney D
• Rok publikování: 2024
• Druh: Článek v odborném periodiku
• Časopis / Zdroj: American Journal of Hematology
• Fakulta / Pracoviště MU: Lékařská fakulta
• www: https://onlinelibrary.wiley.com/doi/10.1002/ajh.27246
• Doi: http://dx.doi.org/10.1002/ajh.27246
• Klíčová slova: acute myeloid leukemia; venetoclax; azacitidine
• Popis: Venetoclax-azacitidine is approved for treatment of patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy based on the interim overall survival (OS) analysis of the VIALE-A study (NCT02993523). Here, long-term follow-up is presented to address survival benefit and long-term outcomes with venetoclax-azacitidine. Patients with newly diagnosed AML who were ineligible for intensive chemotherapy were randomized 2:1 to receive venetoclax-azacitidine or placebo-azacitidine. OS was the primary endpoint; complete remission with/without blood count recovery (CR/CRi) was a key secondary endpoint. This final analysis was conducted when 100% of the predefined 360 OS events occurred. In VIALE-A, 431 patients were enrolled to venetoclax-azacitidine (n = 286) or placebo-azacitidine (n = 145). At 43.2 months median follow-up, median OS was 14.7 months (95% confidence interval [CI], 12.1-18.7) with venetoclax-azacitidine, and 9.6 months (95% CI, 7.4-12.7) with placebo-azacitidine (hazard ratio, 0.58 [95% CI, 0.47-0.72], p < .001); the estimated 24-month OS rate was 37.5% and 16.9%, respectively. Median OS for patients with IDH1/2 mutations and those with measurable residual disease responses was reached in this final analysis. CR/CRi rate was similar to interim analysis. Any-grade hematologic and gastrointestinal adverse events were most common in venetoclax-azacitidine and placebo-azacitidine arms, including thrombocytopenia (47% and 42%) and neutropenia (43% and 29%). No new safety signals were identified. Long-term efficacy and safety confirm venetoclax-azacitidine is an improvement in standard-of-care for patients with AML who are not eligible for intensive chemotherapy because of advanced age or comorbidities.