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Inotuzumab ozogamicin plus low-intensity chemotherapy in older patients with newly diagnosed CD22+ Ph− B-ALL: Results from the EWALL-INO trial
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The phase II EWALL-INO trial (NCT03249870) was an open-label, prospective, multicenter trial of older patients (≥55 years) with newly diagnosed CD22+ Ph− B-ALL. Patients (N = 131) received induction 1 with vincristine, dexamethasone, and three injections of InO (0.8 mg/m2 Day 1, 0.5 mg/m2 Days 8 and 15), followed by induction 2 combining cyclophosphamide, dexamethasone, and two injections of InO (0.5 mg/m2 Days 1 and 8). The primary endpoint was 1-year OS. Results were published in the Journal of Clinical Oncology by Chevallier et al.1 |
| Key learnings |
| After inductions 1 and 2, CR/CRp was achieved in 88.5% of patients (56.4% had MRD2 <10-4) and 90% of patients (80% had MRD2 <10-4), respectively. |
| With a median follow-up of 31.3 months, 1-year and 2-year OS rates were 73.2% and 55%. The median OS, EFS, and RFS were 33.7 months, 20.6 months, and 24 months. The 1-year and 2-year EFS rates were 64% and 46%, RFS rates were 66% and 50%, and CIR rates were 25% and 38%, respectively. |
| Among the responders, 49 patients relapsed and 14 patients died. During inductions 1 and 2, Grade 4 neutropenia occurred in 87% and 100% of patients, respectively, and Grade 3–4 thrombocytopenia occurred in 22% and 12% of patients, respectively. |
| Multivariate analysis showed that high-risk cytogenetics was associated with lower OS (HR, 2.90; p < 0.001), and lower CD22 expression (<70%) was associated with worse OS (HR, 0.52; p = 0.03). Both high-risk cytogenetics and MRD2 ≥10−4 were associated with lower RFS and a higher CIR. |
| Overall, promising efficacy and safety data from the EWALL-INO study suggest that InO plus low-intensity chemotherapy could be a viable treatment option for older patients with untreated Ph− B-ALL. |
Abbreviations: B-ALL, B-cell precursor acute lymphoblastic leukemia; CIR, cumulative incidence of relapse; CR, complete remission; CRp, CR with incomplete platelet recovery <100 Giga/L; EFS, event-free survival; EWALL, European Working Group for Adult Acute Lymphoblastic Leukemia; HR, hazard ratio; InO, inotuzumab ozogamicin; Ph−, Philadelphia chromosome-negative; MRD, measurable residual disease; MRD2, MRD after induction 2; OS, overall survival; RFS, relapse-free survival.
- Chevallier P, Leguay T, Delord M, et al. Inotuzumab ozogamicin and low-intensity chemotherapy in older patients with newly diagnosed CD22+ Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. J Clin Oncol. 2024. Online ahead of print. DOI: 10.1200/JCO.24.00490
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