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Impact of inotuzumab ozogamicin prior to allo-HSCT in adult patients with R/R B-ALL

Mar 7, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in acute lymphoblastic leukemia.

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Adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) have a poor prognosis and a low long-term survival rate of 10%. Inotuzumab ozogamicin (InO) has achieved deep remissions and measurable residual disease (MRD) negativity in patients with R/R B-ALL in the phase III INO-VATE trial (NCT01564784); however, remissions are not durable, necessitating further consolidation approaches, such as allogeneic hematopoietic stem cell transplantation (allo-HSCT) which increases the risk of sinusoidal obstruction syndrome (SOS).

Here, we summarize a retrospective study published by Kayser et al.1 in Haematologica on the impact of InO prior to allo-HSCT in patients with R/R B-ALL, with a focus on risk for SOS.

Study methods1

  • Included patients with R/R B-ALL, aged 16−69 years, who were treated with InO between 2016 and 2022, and subsequently received allo-HSCT.

Key findings1

  • A total of 58 patients were evaluated
  • The complete remission rate prior to allo-HSCT was 84%.
  • Among MRD evaluable patients (n = 44), MRD negativity was achieved in 59%.
  • At a median follow-up of 30.5 months, the median overall survival was 11.2 months.
  • The 1-year and 2-year overall survival rates were 50% and 36.7%, respectively.
  • Overall, progressive disease was reported in 20 patients, which resulted in 15 deaths. The remaining five patients are still alive.
  • The cumulative incidence of relapse and death was 35.0% and 37.6%, respectively.
  • The post-allo-HSCT SOS was reported in 17 patients. Nine patients died due to SOS and multi-organ failure.
  • Multivariate analyses showed that double alkylators (p = 0.038), allo-HSCT during first-line therapy (p = 0.050), and in trend allo-HSCT ≤60 days from the last InO application (p = 0.07) were significantly associated with an increased risk for SOS.
Key learnings
  • Results show that InO is an effective approach with successful bridge-to-transplant in patients with R/R B-ALL.
  • InO showed a high risk of SOS; therefore, careful monitoring, and identification of associated risk factors, such as double alkylating conditioning regimens prior to allo-HSCT are needed to mitigate these risks.

  1. Kayser S, Sartor C, Giglio F, et al. Impact of inotuzumab ozogamicin on outcome in relapsed or refractory acute B-cell lymphoblastic leukemia patients prior to allogeneic hematopoietic stem cell transplantation and risk of sinusoidal obstruction syndrome/venous occlusive disease. Haematologica. 2023. Online ahead of print. DOI: 3324/haematol.2023.284310


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