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2024-08-23T11:52:49.000Z

Impact of leukemic molecular profile on the efficacy of inotuzumab ozogamicin in R/R ALL

Aug 23, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL

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Results from the phase III INO-VATE (NCT01564784) trial evaluating the efficacy of inotuzumab ozogamicin (InO) for the treatment of relapsed/refractory acute lymphoblastic leukemia (R/R ALL) were published in Blood Advances by Zhao et al.Responses to InO were recorded in 91 patients by leukemic subtype, genomic alterations, and risk status.

Key learnings

The median overall survival was 7.7 months with InO compared with 6.2 months with standard of care (SoC) chemotherapy (hazard ratio, 0.75; p = 0.0105).

Patients with high-risk molecular profiles experienced improved complete remission (CR) and CR with incomplete hematologic recovery (CRi) rates with InO compared with SoC chemotherapy (74.7% vs 33.3%; p < 0.001). 

  • Patients with high-risk BCR::ABL1 (BCR::ABL1-like, low-hypodiploid, KMT2A-rearranged) had a CR rate of 83.3% with InO and 10.5% with SoC (p < 0.0001).
  • The CR rate in the BCR::ABL1-like subtype was 85.7% vs 0% with InO vs SoC chemotherapy, respectively.

The CR rate in patients with TP53 alterations was also higher with InO compared with SoC chemotherapy (100% vs 12.5%; p = 0.0047).

The findings from the study suggest that InO may be a viable option for patients with R/R ALL, particularly those with high-risk molecular profiles, offering personalized treatment strategies. Further exploration of InO efficacy is needed in patients with BCR::ABL1-like subtype and TP53 alterations.

  1. Zhao Y, Laird A, Roberts K, et al. Association of leukemic molecular profile with efficacy of inotuzumab ozogamicin in adults with relapsed/refractory ALL. Blood Advances. 2024;8(12):3226-3236. DOI: 1182/bloodadvances.2023012430

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