December 3, 2015Blood
Complete Molecular and Hematologic Response in Adult Patients with Relapsed/Refractory (R/R) Philadelphia Chromosome-Positive B-Precursor Acute Lymphoblastic Leukemia (ALL) Following Treatment with Blinatumomab: Results from a Phase 2 Single-Arm, Multicenter Study (ALCANTARA)
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Discussion
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Implication
Phase 2 single-arm trial demonstrates antileukemic activity of blinatumomab in refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, indicating a viable salvage option.
Key Points
- To evaluate the efficacy and tolerability of blinatumomab in adults with relapsed or refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia resistant or intolerant to second- or later-generation tyrosine kinase inhibitors.
- Conducted a multicenter, single-arm phase 2 study in 45 adult patients with Ph+ B-precursor ALL who relapsed after, were refractory to, or were intolerant to 2nd- or later-generation TKIs (or intolerant/refractory to imatinib).
- Administered blinatumomab via continuous intravenous infusion in 4-week on/2-week off cycles for up to 5 cycles (9 μg/day during days 1–7 of cycle 1, and 28 μg/day thereafter).
- Assessed complete remission (CR) or CR with partial hematologic recovery (CRh) during the first two cycles as the primary endpoint; secondary endpoints included complete minimal residual disease (MRD) response by RT-PCR, relapse-free survival (RFS), and overall survival (OS).
- The primary endpoint of CR/CRh within the first two cycles was reached by 36% of patients (16/45; 95% CI: 22% to 51%), with 14 patients achieving CR (71% of these in cycle 1).
- Complete MRD response was observed in 86% of CR responders (12/14) and 100% of CRh responders (2/2), including 4 of 4 responders carrying the T315I mutation.
- Median RFS was 6.7 months (95% CI: 4.4, not estimable) and median OS was 7.1 months (95% CI: 5.6, not estimable); grade ≥3 adverse events occurred in 82% of patients, commonly febrile neutropenia (27%) and thrombocytopenia (22%).
Cite This Study
Martinelli et al. (2015) studied this question.