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Addition of InO to hyper-CVAD and blinatumomab in younger adults with newly diagnosed Ph-negative B-ALL
Incorporation of blinatumomab and inotuzumab ozogamicin (InO) into the treatment of patients with B-ALL has been shown to improve rates of MRD negativity and patient outcomes. Kantarjian et al.1 conducted a study to determine whether adding InO to hyper-CVAD and blinatumomab could improve outcomes in younger adults with newly diagnosed Ph-negative B-ALL. A total of 79 patients were enrolled between November 2016 and June 2023.1 The median age was 33 years (range, 18–59 years) and 45% of patients had ≥1 high-risk cytogenetic or molecular disease feature prior to treatment.1 Patients in Cohort 1 (n = 38) received hyper-CVAD and sequential blinatumomab without InO.1 For patients in Cohort 2 (n = 38), InO 0.3 mg/m2 was added to two cycles of methotrexate and cytarabine and two cycles of blinatumomab on Days 1 and 8. Key endpoints included MRD negativity, RFS, and OS rates. Results were published in the American Journal of Hematology.1
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Key learnings |
| The overall median follow-up was 44 months; 26 months in Cohort 2. MRD negativity (10−6) was achieved in 79% of patients in Cohort 2. Patients who received InO experienced better 3-year OS vs those who did not (100% vs 82%; p = 0.01). |
| Estimated 3-year RFS rate was also improved with InO at 90% vs 74% without (p = 0.06). Three patients experienced a relapse; two relapses occurred in the CNS and one in the bone marrow, at a median of 16 months from CR. |
| No patients experienced sinusoidal obstruction syndrome or CRS. The most common non-hematologic AEs were febrile neutropenia and infections (68%), transaminitis (38%), and hyperglycemia (22%). Blinatumomab-related neurotoxicity was observed in 19% of patients. |
| Results from this study show that the addition of InO to hyper-CVAD and blinatumomab improves outcomes for younger patients with newly diagnosed B-ALL. A prospective randomized trial is ongoing to confirm these findings. |
Abbreviations: AE, adverse event, B-ALL, B-cell acute lymphoblastic leukemia; CNS, central nervous system; CR, complete remission; CRS, cytokine release syndrome; CVAD, cyclophosphamide-vincristine sulfate-doxorubicin hydrochloride-dexamethasone; InO, inotuzumab ozogamicin; MRD, measurable residual disease; OS, overall survival; Ph, Philadelphia chromosome; RFS, relapse-free survival.
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