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

Standard

Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. / Pratz, Keith W; Jonas, Brian A; Pullarkat, Vinod; Thirman, Michael J; Garcia, Jacqueline S; Döhner, Hartmut; Récher, Christian; Fiedler, Walter; Yamamoto, Kazuhito; Wang, Jianxiang; Yoon, Sung-Soo; Wolach, Ofir; Yeh, Su-Peng; Leber, Brian; Esteve, Jordi; Mayer, Jiri; Porkka, Kimmo; Illés, Árpád; Lemoli, Roberto M; Turgut, Mehmet; Ku, Grace; Miller, Catherine; Zhou, Ying; Zhang, Meng; Chyla, Brenda; Potluri, Jalaja; DiNardo, Courtney D.

In: AM J HEMATOL, Vol. 99, No. 4, 04.2024, p. 615-624.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Pratz, KW, Jonas, BA, Pullarkat, V, Thirman, MJ, Garcia, JS, Döhner, H, Récher, C, Fiedler, W, Yamamoto, K, Wang, J, Yoon, S-S, Wolach, O, Yeh, S-P, Leber, B, Esteve, J, Mayer, J, Porkka, K, Illés, Á, Lemoli, RM, Turgut, M, Ku, G, Miller, C, Zhou, Y, Zhang, M, Chyla, B, Potluri, J & DiNardo, CD 2024, 'Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia', AM J HEMATOL, vol. 99, no. 4, pp. 615-624. https://doi.org/10.1002/ajh.27246

APA

Pratz, K. W., Jonas, B. A., Pullarkat, V., Thirman, M. J., Garcia, J. S., Döhner, H., Récher, C., Fiedler, W., Yamamoto, K., Wang, J., Yoon, S-S., Wolach, O., Yeh, S-P., Leber, B., Esteve, J., Mayer, J., Porkka, K., Illés, Á., Lemoli, R. M., ... DiNardo, C. D. (2024). Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. AM J HEMATOL, 99(4), 615-624. https://doi.org/10.1002/ajh.27246

Vancouver

Pratz KW, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Döhner H et al. Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia. AM J HEMATOL. 2024 Apr;99(4):615-624. https://doi.org/10.1002/ajh.27246

Bibtex

@article{e7b3c08fcf7a47efb29f6bcb047c9006,
title = "Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia",
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.",
author = "Pratz, {Keith W} and Jonas, {Brian A} and Vinod Pullarkat and Thirman, {Michael J} and Garcia, {Jacqueline S} and Hartmut D{\"o}hner and Christian R{\'e}cher and Walter Fiedler and Kazuhito Yamamoto and Jianxiang Wang and Sung-Soo Yoon and Ofir Wolach and Su-Peng Yeh and Brian Leber and Jordi Esteve and Jiri Mayer and Kimmo Porkka and {\'A}rp{\'a}d Ill{\'e}s and Lemoli, {Roberto M} and Mehmet Turgut and Grace Ku and Catherine Miller and Ying Zhou and Meng Zhang and Brenda Chyla and Jalaja Potluri and DiNardo, {Courtney D}",
note = "{\textcopyright} 2024 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.",
year = "2024",
month = apr,
doi = "10.1002/ajh.27246",
language = "English",
volume = "99",
pages = "615--624",
journal = "AM J HEMATOL",
issn = "0361-8609",
publisher = "Wiley-Liss Inc.",
number = "4",

}

RIS

TY - JOUR

T1 - Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia

AU - Pratz, Keith W

AU - Jonas, Brian A

AU - Pullarkat, Vinod

AU - Thirman, Michael J

AU - Garcia, Jacqueline S

AU - Döhner, Hartmut

AU - Récher, Christian

AU - Fiedler, Walter

AU - Yamamoto, Kazuhito

AU - Wang, Jianxiang

AU - Yoon, Sung-Soo

AU - Wolach, Ofir

AU - Yeh, Su-Peng

AU - Leber, Brian

AU - Esteve, Jordi

AU - Mayer, Jiri

AU - Porkka, Kimmo

AU - Illés, Árpád

AU - Lemoli, Roberto M

AU - Turgut, Mehmet

AU - Ku, Grace

AU - Miller, Catherine

AU - Zhou, Ying

AU - Zhang, Meng

AU - Chyla, Brenda

AU - Potluri, Jalaja

AU - DiNardo, Courtney D

N1 - © 2024 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.

PY - 2024/4

Y1 - 2024/4

N2 - 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.

AB - 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.

U2 - 10.1002/ajh.27246

DO - 10.1002/ajh.27246

M3 - SCORING: Journal article

C2 - 38343151

VL - 99

SP - 615

EP - 624

JO - AM J HEMATOL

JF - AM J HEMATOL

SN - 0361-8609

IS - 4

ER -