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 (ClinicalTrials.gov 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.
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).
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.”
- 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]