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Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Zeidner J.F.
  • Sallman D.A.
  • Récher C.
  • Daver N.G.
  • Leung A.Y.H.
  • Hiwase D.K.
  • Subklewe M.
  • Pabst T.
  • Larson R.A.
  • Wilde L.
  • Enjeti A.K.
  • Kawashima I.
  • Papayannidis C.
  • O'Nions J.
  • Johnson L.
  • Dong M.
  • Huang J.
  • Bagheri T.
  • Hacohen Kleiman G.
  • Lee C.
  • Vyas P.

Grupos

Abstract

Patients with TP53-mutated acute myeloid leukemia (AML) have an extremely poor prognosis, necessitating new treatments. The global, randomized, phase 3 ENHANCE-2 trial evaluated the anti-CD47 monoclonal antibody magrolimab plus azacitidine (Magro/Aza) for previously untreated TP53-mutated AML. Patients determined ineligible for intensive therapy were randomized to receive Magro/Aza or venetoclax plus Aza (Ven/Aza); those eligible for intensive therapy were randomized to receive Magro/Aza or 7+3 induction chemotherapy. The primary end point was overall survival (OS) in the nonintensive arm. At interim analysis, nonintensive-arm OS hazard ratio (HR) between treatment groups was 1.191 (95% confidence interval [CI], 0.744-1.906), meeting the study's definition for futility and resulting in study termination. At final analysis, median OS was 4.4 vs 6.6 months (HR, 1.132; 95% CI, 0.783-1.637; P = .5070) in the nonintensive arm (n = 205) and 7.3 vs 11.1 months (HR, 1.434; 95% CI, 0.635-3.239; P = .3798) in the intensive arm (n = 52) between Magro/Aza and control groups, respectively. Incidences of grade =3 adverse events were similar across Magro/Aza and control groups (nonintensive, n = 194: 96.9% and 95.9%; intensive, n = 50: 92.6% and 95.7%), including grade =3 anemia (nonintensive: 27.1% and 23.5%; intensive: 25.9% and 21.7%). Grade =3 infections were observed in 50.0% and 53.1% of patients in the nonintensive arm and 44.4% and 65.2% of intensive-arm patients. ENHANCE-2 did not meet its primary end point of OS in TP53-mutated AML but provides important data informing future studies in this challenging population. This trial was registered at www.clinicaltrials.gov as #NCT04778397. © 2025 American Society of Hematology

Datos de la publicación

ISSN/ISSNe:
0006-4971, 1528-0020

BLOOD  ELSEVIER

Tipo:
Article
Páginas:
590-600
PubMed:
40009500
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
4,834 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; azacitidine; creatinine; cytarabine; daunorubicin; hemoglobin; idarubicin; magrolimab; protein p53; venetoclax; abdominal pain; acute myeloid leukemia; aged; anemia; arthralgia; Article; asthenia; bilirubin blood level; cancer patient; cancer survival; cause of death; consolidation chemotherapy; constipation; continuous infusion; controlled study; coughing; creatinine blood level; death; decreased appetite; diarrhea; drug dose increase; drug efficacy; drug safety; drug withdrawal; dyspnea; ECOG Performance Status; epistaxis; falling; fatigue; febrile neutropenia; female; fever; follow up; gene mutation; headache; hemoglobin blood level; high throughput sequencing; human; hypertransaminasemia; hypoalbuminemia; hypokalemia; hypomagnesemia; hyponatremia; hypophosphatemia; hypotension; incidence; induction chemotherapy; infection; infusion related reaction; injection site reaction; intensive care; karyotype; leukoc

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