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Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations

Standard

Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. / Pollyea, Daniel A; DiNardo, Courtney D; Arellano, Martha L; Pigneux, Arnaud; Fiedler, Walter; Konopleva, Marina; Rizzieri, David A; Smith, B Douglas; Shinagawa, Atushi; Lemoli, Roberto M; Dail, Monique; Duan, Yinghui; Chyla, Brenda; Potluri, Jalaja; Miller, Catherine L; Kantarjian, Hagop M.

in: CLIN CANCER RES, Jahrgang 28, Nr. 13, 01.07.2022, S. 2753-2761.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Pollyea, DA, DiNardo, CD, Arellano, ML, Pigneux, A, Fiedler, W, Konopleva, M, Rizzieri, DA, Smith, BD, Shinagawa, A, Lemoli, RM, Dail, M, Duan, Y, Chyla, B, Potluri, J, Miller, CL & Kantarjian, HM 2022, 'Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations', CLIN CANCER RES, Jg. 28, Nr. 13, S. 2753-2761. https://doi.org/10.1158/1078-0432.CCR-21-3467

APA

Pollyea, D. A., DiNardo, C. D., Arellano, M. L., Pigneux, A., Fiedler, W., Konopleva, M., Rizzieri, D. A., Smith, B. D., Shinagawa, A., Lemoli, R. M., Dail, M., Duan, Y., Chyla, B., Potluri, J., Miller, C. L., & Kantarjian, H. M. (2022). Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. CLIN CANCER RES, 28(13), 2753-2761. https://doi.org/10.1158/1078-0432.CCR-21-3467

Vancouver

Pollyea DA, DiNardo CD, Arellano ML, Pigneux A, Fiedler W, Konopleva M et al. Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. CLIN CANCER RES. 2022 Jul 1;28(13):2753-2761. https://doi.org/10.1158/1078-0432.CCR-21-3467

Bibtex

@article{b52bbd017145427485df867816e3ccd5,
title = "Impact of Venetoclax and Azacitidine in Treatment-Na{\"i}ve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations",
abstract = "PURPOSE: To evaluate efficacy and safety of venetoclax + azacitidine among treatment-na{\"i}ve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).PATIENTS AND METHODS: Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).RESULTS: In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.CONCLUSIONS: Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.",
author = "Pollyea, {Daniel A} and DiNardo, {Courtney D} and Arellano, {Martha L} and Arnaud Pigneux and Walter Fiedler and Marina Konopleva and Rizzieri, {David A} and Smith, {B Douglas} and Atushi Shinagawa and Lemoli, {Roberto M} and Monique Dail and Yinghui Duan and Brenda Chyla and Jalaja Potluri and Miller, {Catherine L} and Kantarjian, {Hagop M}",
year = "2022",
month = jul,
day = "1",
doi = "10.1158/1078-0432.CCR-21-3467",
language = "English",
volume = "28",
pages = "2753--2761",
journal = "CLIN CANCER RES",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "13",

}

RIS

TY - JOUR

T1 - Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations

AU - Pollyea, Daniel A

AU - DiNardo, Courtney D

AU - Arellano, Martha L

AU - Pigneux, Arnaud

AU - Fiedler, Walter

AU - Konopleva, Marina

AU - Rizzieri, David A

AU - Smith, B Douglas

AU - Shinagawa, Atushi

AU - Lemoli, Roberto M

AU - Dail, Monique

AU - Duan, Yinghui

AU - Chyla, Brenda

AU - Potluri, Jalaja

AU - Miller, Catherine L

AU - Kantarjian, Hagop M

PY - 2022/7/1

Y1 - 2022/7/1

N2 - PURPOSE: To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).PATIENTS AND METHODS: Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).RESULTS: In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.CONCLUSIONS: Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.

AB - PURPOSE: To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).PATIENTS AND METHODS: Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).RESULTS: In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.CONCLUSIONS: Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.

U2 - 10.1158/1078-0432.CCR-21-3467

DO - 10.1158/1078-0432.CCR-21-3467

M3 - SCORING: Journal article

C2 - 35046058

VL - 28

SP - 2753

EP - 2761

JO - CLIN CANCER RES

JF - CLIN CANCER RES

SN - 1078-0432

IS - 13

ER -