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<p>Intensive chemotherapy remains the standard for newly diagnosed (ND) acute myeloid leukemia (AML); however, relapse risk remains high. Additionally, most patients with relapsed/refractory (RR) AML have poor outcomes. We report the long-term experience of 138 patients, 77 ND and 61 RR, treated with FLAG-IDA in combination with venetoclax. In the ND cohort, the overall response rate (ORR) was 97%, with a composite complete remission (CRc) rate of 95% and undetectable measurable residual disease (MRD) status by flow cytometry in 90%. The 3-year OS and EFS rates were 66 and 64%, respectively. Outcomes were similar across European LeukemiaNet (ELN) 2022 risk groups. Sixty-four percent transitioned to allogeneic hematopoietic stem cell transplantation (allo-SCT) in CR1. In the RR cohort, the ORR was 67%; CRc rate 41% and flow negative MRD rate 74%; 57% transitioned to allo-SCT. The patients with RR AML in first salvage with wild-type TP53 status had particularly favorable outcomes, with an ORR of 79%, CRc rate of 74% (76% MRD undetectable) and 3-year OS rate of 51%. Infectious and hematologic adverse events were common, with low 30- and 60-day mortality similar to other intensive chemotherapy regimens. FLAG-IDA + VEN is effective for remission induction in both ND and RR AML.</p><p><b>ClinicalTrials.gov Identifier:</b> <a href="https://www.clinicaltrials.gov/study/NCT03214562">NCT03214562</a></p>

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Long term results of venetoclax combined with FLAG-IDA induction and consolidation for newly diagnosed and relapsed or refractory acute myeloid leukemia

  • 期刊论文

  • 发表日期：

    2025年2月25日

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  • Courtney D. DiNardo,
  • Wei-Ying Jen,
  • Koichi Takahashi,
  • Tapan M. Kadia,
  • Sanam Loghavi,
  • Naval G. Daver,
  • Lianchun Xiao,
  • Patrick K. Reville,
  • Ghayas C. Issa,
  • Nicholas J. Short,
  • Koji Sasaki,
  • Sa A. Wang,
  • Jillian K. Mullin,
  • Sherry Pierce,
  • Corey Bradley,
  • Gautam Borthakur,
  • Abhishek Maiti,
  • Yesid Alvarado,
  • Naveen Pemmaraju,
  • Alessandra Ferrajoli,
  • Mahesh Swaminathan,
  • Maro Ohanian,
  • Hussein A. Abbas,
  • Danielle Hammond,
  • Jan Burger,
  • Fadi Haddad,
  • Guillermo Montalban-Bravo,
  • Kelly Chien,
  • Lucia Masarova,
  • Musa Yilmaz,
  • Nitin Jain,
  • Michael Andreeff,
  • Guillermo Garcia-Manero,
  • Steven Kornblau,
  • Farhad Ravandi,
  • Elias Jabbour,
  • Marina Y. Konopleva,
  • Hagop M. Kantarjian

摘要

Intensive chemotherapy remains the standard for newly diagnosed (ND) acute myeloid leukemia (AML); however, relapse risk remains high. Additionally, most patients with relapsed/refractory (RR) AML have poor outcomes. We report the long-term experience of 138 patients, 77 ND and 61 RR, treated with FLAG-IDA in combination with venetoclax. In the ND cohort, the overall response rate (ORR) was 97%, with a composite complete remission (CRc) rate of 95% and undetectable measurable residual disease (MRD) status by flow cytometry in 90%. The 3-year OS and EFS rates were 66 and 64%, respectively. Outcomes were similar across European LeukemiaNet (ELN) 2022 risk groups. Sixty-four percent transitioned to allogeneic hematopoietic stem cell transplantation (allo-SCT) in CR1. In the RR cohort, the ORR was 67%; CRc rate 41% and flow negative MRD rate 74%; 57% transitioned to allo-SCT. The patients with RR AML in first salvage with wild-type TP53 status had particularly favorable outcomes, with an ORR of 79%, CRc rate of 74% (76% MRD undetectable) and 3-year OS rate of 51%. Infectious and hematologic adverse events were common, with low 30- and 60-day mortality similar to other intensive chemotherapy regimens. FLAG-IDA + VEN is effective for remission induction in both ND and RR AML.

ClinicalTrials.gov Identifier: NCT03214562