BLAST, the pivotal study in patients with MRD(+) B-cell precursor ALL: Study design: N=86, an open-label, single-arm phase 2 study of
adult patients with MRD(+) B-cell precursor ALL who had received at least 3 chemotherapy blocks of standard ALL therapy, were in hematologic complete remission (defined as < 5% blasts in bone marrow, absolute neutrophil count > 1 Gi/L, platelets > 100 Gi/L), and had MRD* at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01%. Primary endpoint: 81% (n=70/86) of patients had no detectable MRD assessed after 1 treatment cycle with BLINCYTO®.1,2,*
TOWER, the landmark study in patients with R/R B-cell precursor ALL: A large (N=405), international, randomized, controlled, phase 3
study of single-agent BLINCYTO® vs SOC chemotherapy in patients ≥ 18 years of age: refractory to primary induction therapy or to last
therapy, in first relapse (first remission duration < 12 months), in second or later relapse, or in any relapse after HSCT. Primary endpoint was
mOS: 7.7 months for BLINCYTO® (n=271) vs 4.0 months for SOC chemotherapy (n=134); P = 0.012; HR: 0.71 (95% Cl: 0.55–0.93).1,6