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

J 2024

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 et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

001240529600001

Keywords in English

acute myeloid leukemia; venetoclax; azacitidine

Abstract

V originále

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.

Citovat

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.

@article{2407782,
   author = {Pratz, Keith W and Jonas, Brian A and Pullarkat, Vinod and Thirman, Michael J and Garcia, Jacqueline S and Doehner, Hartmut and Recher, Christian and Fiedler, Walter and Yamamoto, Kazuhito and Wang, Jianxiang and Yoon, SungandSoo and Wolach, Ofir and Yeh, SuandPeng and Leber, Brian and Esteve, Jordi and Mayer, Jiří and Porkka, Kimmo and Illes, Arpad and Lemoli, Roberto M and Turgut, Mehmet and Ku, Grace and Miller, Catherine and Zhou, Ying and Zhang, Meng and Chyla, Brenda and Potluri, Jalaja and Dinardo, Courtney D},
   article_location = {Hoboken},
   article_number = {4},
   doi = {http://dx.doi.org/10.1002/ajh.27246},
   keywords = {acute myeloid leukemia; venetoclax; azacitidine},
   language = {eng},
   issn = {0361-8609},
   journal = {American Journal of Hematology},
   title = {Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia},
   url = {https://onlinelibrary.wiley.com/doi/10.1002/ajh.27246},
   volume = {99},
   year = {2024}
}

TY  - JOUR
ID  - 2407782
AU  - 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
PY  - 2024
TI  - Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia
JF  - American Journal of Hematology
VL  - 99
IS  - 4
SP  - 615-624
EP  - 615-624
PB  - Wiley-Blackwell
SN  - 03618609
KW  - acute myeloid leukemia
KW  - venetoclax
KW  - azacitidine
UR  - https://onlinelibrary.wiley.com/doi/10.1002/ajh.27246
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.
ER  -

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. \textit{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.

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