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<p>Inotuzumab ozogamicin, an anti-CD22 antibody-drug conjugate, has demonstrated high response rates and measurable residual disease (MRD)-negativity in acute lymphoblastic leukemia (ALL). This phase 2 single-center study evaluated inotuzumab 0.6 mg/m<sup>2</sup> day 1 and 0.3 mg/m<sup>2</sup> day 8 (cycle 1) followed by 0.3 mg/m<sup>2</sup> days 1 and 8 (cycles 2–6) for adults with B-cell ALL in morphologic remission with detectable MRD (≥1 × 10<sup>−4</sup> by multiparameter flow cytometry, <i>BCR::ABL1</i> transcripts ≥0.01% by polymerase chain reaction [PCR], or ≥1 × 10<sup>−6</sup> by next-generation sequencing [NGS]). Thirty-seven patients (median age 49 years) were treated, including 17 with Philadelphia-chromosome (Ph)-negative ALL and 20 with Ph-positive ALL. Twenty-eight patients (76%) were in first remission (CR1). Overall, 26 patients (70%) achieved MRD-negativity, including 76% of patients with Ph-negative ALL and 65% of patients with Ph-positive ALL. The NGS MRD-negativity rate was 73%. With a median follow-up of 50 months, the median overall survival (OS) was 61 months, with a median relapse-free survival (RFS) of 40 months. Patients treated in CR1 vs CR2+ had a median OS that was not reached versus 14 months, respectively (<i>p</i> = 0.056). Three cases (8%) of non-fatal sinusoidal obstructive syndrome (SOS) were observed. Inotuzumab was safe and effective at eradicating MRD.</p>

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Inotuzumab ozogamicin therapy for measurable residual disease in adult acute lymphoblastic leukemia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月27日

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  • Elias Jabbour,
  • Caitlin R. Rausch,
  • Hannah Goulart,
  • Nitin Jain,
  • Farhad Ravandi,
  • Abhishek Maiti,
  • Yesid Alvarado,
  • Jan Burger,
  • Musa Yilmaz,
  • Issa Khouri,
  • Partow Kebriaei,
  • Jeffrey Jorgensen,
  • Sa A. Wang,
  • Xuemei Wang,
  • Ejiroghene Mayor,
  • Rebecca S. Garris,
  • Nicholas J. Short,
  • Hagop Kantarjian

摘要

Inotuzumab ozogamicin, an anti-CD22 antibody-drug conjugate, has demonstrated high response rates and measurable residual disease (MRD)-negativity in acute lymphoblastic leukemia (ALL). This phase 2 single-center study evaluated inotuzumab 0.6 mg/m2 day 1 and 0.3 mg/m2 day 8 (cycle 1) followed by 0.3 mg/m2 days 1 and 8 (cycles 2–6) for adults with B-cell ALL in morphologic remission with detectable MRD (≥1 × 10−4 by multiparameter flow cytometry, BCR::ABL1 transcripts ≥0.01% by polymerase chain reaction [PCR], or ≥1 × 10−6 by next-generation sequencing [NGS]). Thirty-seven patients (median age 49 years) were treated, including 17 with Philadelphia-chromosome (Ph)-negative ALL and 20 with Ph-positive ALL. Twenty-eight patients (76%) were in first remission (CR1). Overall, 26 patients (70%) achieved MRD-negativity, including 76% of patients with Ph-negative ALL and 65% of patients with Ph-positive ALL. The NGS MRD-negativity rate was 73%. With a median follow-up of 50 months, the median overall survival (OS) was 61 months, with a median relapse-free survival (RFS) of 40 months. Patients treated in CR1 vs CR2+ had a median OS that was not reached versus 14 months, respectively (p = 0.056). Three cases (8%) of non-fatal sinusoidal obstructive syndrome (SOS) were observed. Inotuzumab was safe and effective at eradicating MRD.