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Inotuzumab ozogamicin for adult patients with B-ALL in CR with positive MRD: a phase II study

Mar 28, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL.

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Detecting measurable residual disease (MRD) is a prognostic biomarker of relapse and survival in acute lymphoblastic leukemia (ALL). In the phase III INO-VATE trial, inotuzumab ozogamicin (InO) demonstrated a higher median overall survival (OS) vs standard chemotherapy (7.7 vs 6.7 months), with an MRD negativity rate of 78%.

Here, we summarize the efficacy and safety results from a phase II trial (NCT03441061) of InO in MRD positive adult patients with B-cell ALL in complete remission (CR), published by Jabbour et al.1 in Blood.

Study design1

  • This study included adult patients aged ≥18 years with B-cell ALL who were in first CR (CR1) or beyond (CR2+) with positive MRD (≥1 × 10−4).
  • Patients received InO at 0.6 mg/m2 on Day 1 and 0.3 mg/m2 on Day 8 of Cycle 1, followed by 0.3 mg/m2 on Days 1 and 8 of Cycles 2−6.
  • The primary endpoint was relapse-free survival.
  • Secondary endpoints included OS; MRD negativity rate, defined as undetectable MRD by multicolor flow cytometry in Philadelphia chromosome-negative ALL and undetectable MRD by multicolor flow cytometry and polymerase chain reaction in Philadelphia chromosome-positive ALL; and safety.


  • A total of 26 patients with a median age of 46 years (range, 1970 years) were treated between November 2018 and June 2022
  • Of treated patients, 73% were in CR1 and 27% were in CR2 and beyond
  • Overall, 69% of patients achieved MRD-negativity after Cycle 1
  • Of responders (n = 18), six patients underwent allogeneic stem cell transplantation, and five patients experienced relapse in the bone marrow (n = 3), in the bone marrow and lymph nodes (n = 1), and in the central nervous system and bone marrow (n = 1)
  • There was a total of nine deaths, due to disease progression (n = 4), allogeneic stem cell transplantation complications (n = 2), septic shock (n = 1), sinusoidal obstruction syndrome (n = 1), and unknown (n = 1).

At a median follow-up of 24 months, the median relapse-free survival was 41 months in the total cohort and responders, and the median OS was not reached in the total cohort and responders; 2-year survival rates are reported in Figure 1.

Figure 1. 2-year response rates* 

OS, overall survival; RFS, relapse-free survival
*Data from Jabbour, et al.1


  • The most common treatment-related adverse events reported were aspartate aminotransferase/alanine aminotransferase elevations and thrombocytopenia (Table 1).
  • Sinusoidal obstruction syndrome was reported in two patients; one case was severe and developed 1 month after Cycle 5 and the other was a moderate case that developed during Cycle 5

Table 1. Treatment-related AEs*

AE, %

Ph− negative ALL

(n = 10)


(n = 16)

ALT/AST level elevation












Abdominal pain/distension






Hepatic SOS









AE, adverse event; ALL, acute lymphoblastic leukemia; ALT/AST, alanine aminotransferase/aspartate aminotransferase; Ph, Philadelphia chromosome; SOS, sinusoidal obstruction syndrome
*Adapted from Jabbour, et al.1

Grade 3 and Grade 4 both 20%.
Grade 3 = 19% and Grade 4 = 13%.
§Grade 4 = 40%.
Grade 4 = 19%.

Key learnings
  • InO was found to be safe and effective in eradicating MRD in adult patients with B-cell ALL who remain in MRD-positive status after achieving CR
  • Further studies are needed to confirm these findings

  1. Jabbour E, Haddad FG, Short NJ, et al. Phase 2 study of inotuzumab ozogamicin for measurable residual disease in acute lymphoblastic leukemia in remission. Blood. 2024. Online ahead of print. DOI: 1182/blood.2023022330


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