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

PRATZ, Keith W, Brian A JONAS, Vinod PULLARKAT, Michael J THIRMAN, Jacqueline S GARCIA, Hartmut DOEHNER, Christian RECHER, Walter FIEDLER, Kazuhito YAMAMOTO, Jianxiang WANG, Sung-Soo YOON, Ofir WOLACH, Su-Peng YEH, Brian LEBER, Jordi ESTEVE, Jiří MAYER, Kimmo PORKKA, Arpad ILLES, Roberto M LEMOLI, Mehmet TURGUT, Grace KU, Catherine MILLER, Ying ZHOU, Meng ZHANG, Brenda CHYLA, Jalaja POTLURI and Courtney D DINARDO. Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. American Journal of Hematology. Hoboken: Wiley-Blackwell, 2024, vol. 99, No 4, p. 615-624. ISSN 0361-8609. Available from: https://dx.doi.org/10.1002/ajh.27246.

Basic information

• Original name: Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia
• Authors: PRATZ, Keith W, Brian A JONAS, Vinod PULLARKAT, Michael J THIRMAN, Jacqueline S GARCIA, Hartmut DOEHNER, Christian RECHER, Walter FIEDLER, Kazuhito YAMAMOTO, Jianxiang WANG, Sung-Soo YOON, Ofir WOLACH, Su-Peng YEH, Brian LEBER, Jordi ESTEVE, Jiří MAYER (203 Czech Republic, belonging to the institution), Kimmo PORKKA, Arpad ILLES, Roberto M LEMOLI, Mehmet TURGUT, Grace KU, Catherine MILLER, Ying ZHOU, Meng ZHANG, Brenda CHYLA, Jalaja POTLURI and Courtney D DINARDO.
• Edition: American Journal of Hematology, Hoboken, Wiley-Blackwell, 2024, 0361-8609.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30205 Hematology
• Country of publisher: United States of America
• Confidentiality degree: is not subject to a state or trade secret
• WWW: URL
• Impact factor: Impact factor: 12.800 in 2022
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1002/ajh.27246
• UT WoS: 001198670600037
• Keywords in English: acute myeloid leukemia; venetoclax; azacitidine
• Tags: 14110212, rivok
• Tags: International impact, Reviewed

Abstract

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.