40%
(n=4/10)
BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
ALCANTARA study design
BLINCYTO® single-agent immunotherapy was evaluated in an open-label, single-arm, multicenter phase 2 study (N=45) in adult patients with R/R Ph(+) B-cell precursor ALL who progressed after or were intolerant to second- or later-generation TKI therapy1,2
BLINCYTO® single-agent immunotherapy2
Key inclusion criteria2 |
---|
Patients ≥ 18 years of age |
Relapsed after or refractory to at least 1 second- or later-generation TKI or intolerant to second- or later-generation TKI and intolerant or refractory to imatinib |
> 5% BM blasts |
ECOG performance status ≤ 2 |
Key exclusion criteria2 |
HSCT within 12 weeks |
Active acute or chronic Grade 2 to 4 GvHD |
Systemic treatment of GvHD within 2 weeks before treatment start |
History or presence of clinically relevant CNS pathology |
Active CNS ALL |
Isolated extramedullary disease |
Baseline demographic and disease characteristics (N=45)1,2
Sex, n (%) | |
---|---|
Male | 24 (53) |
Age group, n (%) | |
18 to < 55 years | 22 (49) |
55 to < 65 years | 11 (24) |
≥ 65 years | 12 (27) |
Prior TKI exposure, n (%)a | |
Dasatinib | 39 (87) |
Imatinbb | 25 (56) |
Ponatinib | 23 (51) |
Nilotinib | 16 (36) |
T3151 mutation , n (%) | 10 (27)c |
Prior HSCT , n (%) | 20 (44) |
≥ 3 prior TKI treatments, n (%) | 17 (38) |
aPrior TKI use was not mutually exclusive.2
bOne patient was resistant to imatinib and was never exposed to a second-generation or later TKI (protocol deviation).2
cOf 37 patients evaluable for TKI mutational analysis.2
ALL, acute lymphoblastic leukemia; BM, bone marrow; CNS, central nervous system; CR, complete remission; CRh*, complete remission with partial hematologic recovery; ECOG, Eastern Cooperative Oncology Group; GvHD, graft versus host disease; HSCT, allogeneic hematopoietic stem cell transplantation; IV, intravenous; MRD, measurable or minimal residual disease; OS, overall survival; Ph(+), Philadelphia chromosome–positive; RFS, relapse-free survival; R/R, relapsed or refractory; TKI, tyrosine kinase inhibitor.
Primary endpoint: CR/CRh* rate within the first 2 treatment cycles1,2
CR was defined as ≤ 5% blasts in the BM, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/mcL and ANC > 1,000/mcL).1
CRh* was defined as ≤ 5% blasts in the BM, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/mcL and ANC > 500/mcL).1
Consistent response across subgroups1,2
40%
(n=4/10)
CR among patients with T315I mutation†
47%
(n=8/17)
CR/CRh* rate among
patients treated with
≥ 3 prior TKIs†
35%
(n=8/23)
CR/CRh* rate among patients who had received prior ponatinib therapy‡
†CR/CRh* in these subgroups was a prespecified analysis in ALCANTARA; however, the CR/CRh* efficacy in these subgroups was not a study objective and the study was not powered to assess CR/CRh* efficacy in these subgroups.4
‡Response in this subgroup is a post hoc analysis in ALCANTARA, thus the efficacy in this subgroup was not a study objective and the study was not powered to assess efficacy in this subgroup.3
88%
(n=14/16)
of patients with CR/CRh* were MRD negative
within
the first 2 treatment cycles1,2
References:
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.
BLINCYTO® is a registered trademark of Amgen Inc.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES