Inotuzumab ozogamicin (InO) may be an effective and tolerable first- or second-line salvage therapy option among older patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL), according to a study published in Cancer.1

Results of the INO-VATE study ( Identifier: NCT01564784) demonstrated that InO improves clinical outcomes among patients with ALL between 18 to 78 years old overall, but the impact of treatment on age-specific subgroups was not fully explored.

For this post-hoc analysis of INO-VATE, researchers evaluated the outcomes of older (> 55 years) vs younger patients with R/R ALL treated with InO 1.8 mg/m2/cycle or investigators’ choice (IC) of chemotherapy. Baseline demographics and disease characteristics were similar between younger and older patients.

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Patients treated with InO had a complete response (CR)/complete response with incomplete hematologic recovery (CRi) rate of 73% compared with 31% of patients treated with IC (1-sided P < .0001).

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The CR/CRi rate was 70% and 75% among older and younger patients (1-sided P = .24), respectively. Progression-free survival, remission rates, and median durations of remission were also similar between the age-specific subgroups, but younger patients had an improved median overall survival (8.6 months vs 5.6 months, respectively).

Grade 3 or worse treatment-emergent adverse events occurred at similar frequencies in older and younger patients, but thrombocytopenia, febrile neutropenia, and γ-glutamyltransferase elevations were reported more frequently among older patients. Older patients who received InO and underwent hematopoietic stem cell transplantation had higher rates of veno-occlusive disease compared with younger patients (41% vs 17%, respectively).

The authors concluded that InO is a safe and effective treatment among older patients with R/R ALL, and added that “lower doses of InO and its combination with low-intensity chemotherapy regimens are being evaluated.”


  1. Jabbour EJ, DeAngelo DJ, Stelljes M, et al. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Jan 30. doi: 10.1002/cncr.31249/full [Epub ahead of print]