Study design: BLINCYTO® single-agent immunotherapy was evaluated in an open-label, single-arm, multicenter phase 2 study (N=45) in adult patients with Ph(+) R/R B-cell precursor ALL who progressed after or were intolerant to second- or later-generation TKI therapy and were intolerant or refractory to imatinib. Primary endpoint was CR/CRh* rate within the first 2 treatment cycles: 36% (n=16/45; 95% CI: 22–51).1,2 Selected secondary endpoints: MRD response rate during the first two cycles of treatment, RFS, OS, HSCT after BLINCYTO®-induced remission.2
BLINCYTO® is an effective treatment for Ph(+) B-cell precursor ALL1
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
CR among patients with T315I mutation†
CR/CRh* rate among
patients treated with
≥ 3 prior TKIs†
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.3
‡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
ALL, acute lymphoblastic leukemia; ANC, absolute neutrophil count; BM, bone marrow; CI, confidence interval; CR, complete remission; CRh*, complete remission with partial hematologic recovery; HSCT, allogeneic hematopoietic stem cell transplantation; MRD, measurable or minimal residual disease; NCCN, National Comprehensive Cancer Network; OS, overall survival; Ph(+), Philadelphia chromosome–positive; RFS, relapse-free survival; R/R, relapsed or refractory; TKI, tyrosine kinase inhibitor.
of patients with CR/CRh* were MRD negative
the first 2 treatment cycles1,2
PCR, polymerase chain reaction.
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 Ph(+) R/R B-cell precursor ALL who progressed after or were intolerant to second- or later-generation TKI therapy and were intolerant or refractory to imatinib.1,2
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 (%)|
|Age group, n (%)|
|18 to < 55 years||22 (49)|
|55 to < 65 years||11 (24)|
|≥ 65 years||12 (27)|
|Prior TKI exposure, n (%)a|
|T315I 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
CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; GvHD, graft versus host disease; IV, intravenous.
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend blinatumomab (BLINCYTO®) as consolidation therapy for patients with Ph(+) R/R B-cell precursor ALL with persistent or rising measurable residual disease (MRD)5,§
§Also referred to as minimal residual disease.
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.
BLINCYTO® is a registered trademark of Amgen Inc.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Martinelli G, Boissel N, Chevallier P, et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome–positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: Results from a phase II, single-arm, multicenter study. J Clin Oncol. 2017;35:1795-1802. 3. Data on file, Amgen; ; 2014. 4. ClinicalTrials.gov. Blinatumomab in adults with relapsed/refractory Philadelphia positive B-precursor acute lymphoblastic leukemia. https://clinicaltrials.gov/ct2/show/NCT02000427. Accessed September 20, 2021. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 28, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.