Hoffmann P, Hofmeister R, Brischwein K, et?al. cycle); patients received 28 g/day blinatumomab in subsequent cycles. Results Twenty of 45 patients enrolled (44%) achieved complete remission with full or partial hematologic recovery compared with 44% in TOWER and 80% and 38% in phase 1b and phase 2, respectively, of Study 265. The KaplanCMeier (KM) median overall survival was 11.9 months (95% confidence interval [CI], 9.9C17.1) and the KM median duration of relapse\free survival was 8.9 months (95% CI, 3.8C10.7). Ninety\three percent of patients had grade 3 treatment\emergent adverse events (AEs) compared with 87% in TOWER and 80% and 100% in phase 1b and phase 2, respectively, of Study 265. Five patients (11.4%) had fatal AEs. Conclusions The safety and efficacy of blinatumomab in Asian patients were comparable with those reported in previous global studies with no new safety signals. (%)18 (40.0)Deaths from any cause18 (40.0)Censored, IgG2a Isotype Control antibody (%)27 (60.0)Alive at last follow\up18 (40.0)Consent withdrawn5 (11.1)Decision by sponsor4 (8.9)Time to event (KM) (months) a Median11.995% CI9.9C17.1Q1, Q39.3, 17.1Min, Max0.1, 20.7Time to censoring (months) a,b ?Median7.6Q1, Q35.1, 13.6Min, Max0.7, 14.1Relapse\free survivalNumber of patients c 20Events, (%)13 (65.0)Relapse6 (30.0)Progressive disease1 (5.0)Death from any cause6 (30.0)Censored, (%)7 (35.0)Alive w/o relapse7 (35.0)Time to event (KM) (months) a Median8.995% CI3.8C10.7Q1, Q34.2, 10.7Min, Max1.4, 19.7Time to censoring (months) a,b MedianNEQ1, Q31.5, NEMin, Max0.0, 2.8 Open in a separate window Note: CR is defined as 5% bone marrow blasts with no evidence of disease and full recovery of peripheral blood counts (platelets? ?100,000/l and ANC? ?1,000/l); CRh is defined as 5% bone marrow blasts with no evidence of disease and partial recovery of peripheral blood counts (platelets? ?50,000/l and ANC? ?500/l). Abbreviations: ANC, absolute neutrophil count; CI, confidence interval; CR, complete remission with full hematologic recovery; CRh, complete remission with partial hematologic recovery of peripheral blood counts; KM, KaplanCMeier; (%) (95% CI)20 (44.4) (29.6C60.0)CR14 (31.1) (18.2C46.6)CRh6 (13.3) (5.1C26.8)Blast\free hypoplastic or aplastic bone marrow (without CRi), (%) (95% CI)6 (13.3) (5.1C26.8)Partial remission, (%) (95% CI)0 (0.0) (NECNE)Progressive disease, (%) (95% CI)3 (6.7) (1.4C18.3)Nonresponse, (%) (95% CI)10 (22.2) (11.2C37.1)Unevaluable/missing post\baseline assessment within 12?weeks, (%)6 (13.3)MRD remission in all patients analyzedNumber of patients45MRD remission, (%) (95% CI)19 (42.2) (27.7C57.8)MRD complete remission, (%) (95% CI)13 (28.9) (16.4C44.3)No MRD remission, (%)15 (33.3)No post\baseline MRD assessment, (%)11 (24.4)MRD remission in patients with CRNumber of patients with CR14MRD remission, (%) (95% CI)11 (78.6) (49.2C95.3)MRD complete remission, (%) (95% CI)9 (64.3) (35.1C87.2)No MRD remission, (%)1 (7.1)No post\baseline MRD assessment, (%)2 (14.3)MRD remission in patients with CR/CRhNumber of BM-131246 patients with CR/CRh20MRD remission, (%) (95% CI)15 (75.0) (50.9C91.3)MRD complete remission, (%) (95% CI)12 (60.0) (36.1C80.9)No MRD remission, (%)2 (10.0)No post\baseline MRD assessment, (%)3 (15.0) Open in a separate window Note: CR is defined as 5% bone marrow blasts with no evidence of disease and full recovery of peripheral blood counts (platelets? ?100,000/l and ANC? ?1,000/l); CRh is defined as 5% bone marrow blasts with no evidence of disease and partial recovery of peripheral blood counts (platelets? ?50,000/l and ANC? ?500/l); CRi is defined as 5% bone marrow blasts with no evidence of disease and incomplete recovery of peripheral blood counts (platelets? ?100,000/l or ANC? ?1,000/l); partial remission is defined as bone marrow blasts in the range of 6%C25% with at least a 50% reduction from baseline; progressive disease is defined as BM-131246 an increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/l in the number of circulating peripheral blasts. MRD remission is defined as fewer than 10C4 detectable blasts, as determined by PCR or flow cytometry; MRD complete remission is defined as no detectable leukemic cells, as determined by PCR or flow cytometry. Abbreviations: ANC, absolute neutrophil count; CI, confidence interval; CR, complete remission with full hematologic recovery; CRh, complete remission with partial hematologic recovery of peripheral blood counts; CRi, complete remission with incomplete hematologic recovery of peripheral blood counts; MRD; minimal residual disease; NE, not estimable; PCR, polymerase chain reaction. a Within the first 12?weeks of treatment. Forty\four patients who received at least one BM-131246 dose of blinatumomab 9C28 g/day were part of the safety analysis set. Forty\one patients (93.2%) reported grade 3 TEAEs and 21 (47.7%) reported serious AEs (Table?3). In addition, five deaths (11.4%) occurred due to acute respiratory failure, pneumonitis, suicide, pneumonia, and tumor lysis syndrome, all of which were considered as non\treatment related by site investigators. Grade 3 TEAEs of interest reported in greater than 20% of the patient population were cytopenia (63.6%), neutropenia (59.1%), and infections (43.2%). TABLE 3 Summary of.