BLINCYTO(blinatumomab)

BLINCYTO (blinatumomab) received Accelerated Approval on March 29, 2018, for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.

Efficacy findings include an overall complete MRD response rate of 81%, with 85% in CR1 and 72% in CR2. The undetectable MRD rate (assay sensitivity < 0.005%) was 81%. The 18-month hematological relapse-free survival (RFS) was 59% overall, 67% in CR1, and 40% in CR2. Median RFS was 22.3 months overall, 35.2 months in CR1, and 12.3 months in CR2. For patients in CR1 with MRD >= 0.1%, median RFS was 9.7 months and 18-month RFS was 40%. Median event-free survival (EFS) for patients in CR2 with MRD as low as 0.01% was 7 months.

Common adverse reactions (≥ 20%) included infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Treatment-related mortality was 2%. Neurological toxicities occurred in 69% of patients, and cytokine release syndrome (CRS) in 7%. Sepsis incidence was 2%. Postmarketing requirements include two randomized trials with primary endpoints of overall survival (approximately 280 patients) and disease-free survival (approximately 598 patients).