Jabbour E et al. Proc ASH 2015;Abstract 83.

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Jabbour E et al. Proc ASH 2015;Abstract 83. Frontline Inotuzumab Ozogamicin in Combination with Low-Intensity Chemotherapy (mini-hyper-CVD) for Older Patients with Acute Lymphoblastic Leukemia (ALL) Jabbour E et al. Proc ASH 2015;Abstract 83.

Inotuzumab Ozogamicin (IO) with R-Mini-Hyper-CVD for Older Patients with Acute Lymphoblastic Leukemia (ALL) Single-arm trial of IO, an antibody-drug conjugate targeting CD22, with R-mini-hyper-CVD (rituximab/cyclophosphamide/dexamethasone/methotrex ate/cytarabine) N = 34 patients aged ≥60 years with untreated B-cell ALL Endpoints: Efficacy and safety Complete response with and without platelet recovery: 30 of 31 evaluable patients (97%) Safety: Grade 3 and 4 toxicities in ≥10% of patients included prolonged thrombocytopenia (n = 27), infections during induction therapy (n = 18), infections during consolidation therapy (n = 25), hyperglycemia (n = 17), hypokalemia (n = 12), hyperbilirubinemia (n = 8), veno- occlusive disease (n = 4) Jabbour E et al. Proc ASH 2015;Abstract 83.

IO with R-Mini-Hyper-CVD for Older Patients with ALL: Conclusions Two-year progression-free survival and overall survival (OS) rates were 87% and 70%. R-mini-hyper-CVD appears to be superior to the historical HCVAD with or without rituximab in a similar patient population (2-year OS 38%). Median 2-y OS IO + R-mini-hyper-CVD Not reached 70% HCVAD +/- rituximab 16 mo 38% Fraction survival p = 0.08 Years Results appear better than those with chemotherapy alone: IO with R-mini-hyper-CVD may become the new standard up-front treatment for older patients with ALL. Jabbour E et al. Proc ASH 2015;Abstract 83.

Investigator Commentary: IO with Mini-HYPER-CVD as Front- Line Therapy for Older Patients with ALL The optimal therapy for older adults with Philadelphia chromosome- negative ALL remains controversial. Many physicians use a dose- reduced legacy regimen such as that from the CALGB-9111 trial or mini-hyper-CVAD. The results with these regimens are poor, with long- term survival rates for adults older than age 60 no higher than 20%. The addition of an antibody-toxin conjugate such as the anti-CD22 targeted agent IO is feasible and led to favorable outcomes, as suggested by this abstract presented by Dr Jabbour. Randomized trials will be required to prove the value of adding IO to a dose-reduced, adult ALL regimen for this age cohort of patients with ALL. Interview with Richard M Stone, MD, February 16, 2016