Azacitidine and venetoclax with or without pevonedistat in patients with newly diagnosed acute myeloid leukemia

被引：0

作者：

Short, Nicholas J. ^{[1
]}

Wierzbowska, Agnieszka ^{[2
]}

Cluzeau, Thomas ^{[3
]}

Laribi, Kamel ^{[4
]}

Recher, Christian ^{[5
]}

Czyz, Jaroslaw ^{[6
,7
]}

Ochrem, Bogdan ^{[8
]}

Ades, Lionel ^{[9
]}

Gallego-Hernanz, Maria Pilar ^{[10
]}

Heiblig, Mael ^{[11
]}

Audisio, Ernesta ^{[12
]}

Zarzycka, Ewa ^{[13
]}

Li, Shuli ^{[14
]}

Ferenc, Nicholas ^{[14
]}

Yeh, Tammie ^{[14
]}

Faller, Douglas V. ^{[14
]}

Sedarati, Farhad ^{[14
]}

Papayannidis, Cristina ^{[15
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, 1515 Holcombe Blvd, Houston, TX 77030 USA

[2] Med Univ Lodz, Dept Hematol, Lodz, Poland

[3] Cote Azur Univ, Ctr Hosp Univ Nice CHU, Dept Hematol, Nice, France

[4] Ctr Hosp Mans, Dept Hematol, Le Mans, France

[5] Univ Toulouse, Univ Paul Sabatier Toulouse 3, Inst Univ Canc Toulouse Oncopole, Toulouse, France

[6] Szpital Uniwersytecki 2, Bydgoszcz, Poland

[7] Nicolaus Copernicus Univ Torun, Dept Hematol, Coll Medicum Bydgoszcz, Bydgoszcz, Poland

[8] Univ Hosp, Dept Hematol, Krakow, Poland

[9] Hop St Louis, AP HP, Dept Hematol & Immunol, Paris, France

[10] CHU Miletrie, Dept Hematol, Poitiers, France

[11] Hop Lyon Sud, Serv Hematol Clin, Hosp Civils Lyon, Lyon, France

[12] Haematol Dept, SC Ematol 2, Turin, Italy

[13] Med Univ Gdansk, Dept Hematol & Transplantol, Gdansk, Poland

[14] Inc TDCA, Takeda Dev Ctr Amer, Lexington, MA USA

[15] Ist Ematol Seragnoli, IRCCS Azienda Osped Univ Bologna, Bologna, Italy

来源：

LEUKEMIA & LYMPHOMA | 2025年 / 66卷 / 03期

关键词：

Acute myeloid leukemia; azacitidine; pevonedistat; phase; 2; venetoclax; OLDER PATIENTS; NEDD8-ACTIVATING ENZYME; AML; RECOMMENDATIONS; INHIBITOR; CARE;

D O I：

10.1080/10428194.2024.2431878

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

This phase 2 study investigated pevonedistat + azacitidine + venetoclax (n = 83) versus azacitidine + venetoclax (n = 81) in patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy. The study was stopped early following negative results from PANTHER, which evaluated pevonedistat in higher-risk myelodysplastic syndromes/chronic myelomonocytic leukemia or low-blast AML. Outcomes were analyzed up to the datacut. For pevonedistat + azacitidine + venetoclax versus azacitidine + venetoclax, the median follow-up was 8.44 versus 7.95 months; the complete remission (CR) rate was 45% versus 49%; composite CR (CCR; CR+CR with incomplete blood count recovery) was 77% versus 72%. There were no differences in event-free survival (primary endpoint; hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.61-1.60; p = 0.477) or overall survival (HR: 1.42; 95% CI: 0.82-2.49; p = 0.896). In exploratory analyses in IDH-mutated AML, CCR rates were higher with pevonedistat + azacitidine + venetoclax versus azacitidine + venetoclax. Safety was similar between treatment arms. Efficacy/safety with azacitidine + venetoclax was consistent with the phase 3 VIALE-A study.Trial registrationNCT04266795

引用

页码：458 / 468

页数：11

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