81%
(n=70/86)
BLINCYTO® is indicated for the treatment of CD19-positive 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.
... Read MoreAdults ≥ 18 years of age with B-cell precursor ALL in hematologic CR1 or CR2 with MRD ≥ 0.1%†
Follow-up:
30 days
(safety);
24 months
plus
5-year survival follow-up
Key inclusion criteria1 |
---|
Adults ≥ 18 years of age with B-cell precursor ALL in hematologic CR |
Measurable residual disease (MRD)§ level of ≥ 0.1% (molecular relapse or molecular failure)** |
< 5% blasts in bone marrow |
ANC > 1 Gi/L |
Platelets > 100 Gi/L |
Key exclusion criteria3 |
Prior HSCT |
Presence of circulating blasts or current extramedullary disease |
History of relevant CNS pathology or current relevant CNS pathology |
Prior systemic cancer chemotherapy within 2 weeks or radiotherapy within 4 weeks |
Baseline characteristics of patients (N=86) | |
---|---|
Age | |
Median, years (min, max) | 43 (18, 76) |
≥ 65 years, n (%) | 10 (12) |
Males, n (%) | 50 (58) |
Philadelphia chromosome disease status, n (%) | |
Positive | 1 (1) |
Negative | 85 (99) |
Relapse history, n (%) | |
In first complete remission (CR1) | 61 (71) |
In second complete remission (CR2) | 25 (29) |
Baseline MRD levels,† n (%) | |
≥ 10% | 7 (8) |
≥ 1% and < 10% | 34 (40) |
≥ 0.1% and < 1% | 45 (52) |
Primary endpoint: complete MRD response††
81%
(n=70/86)
of patients had no detectable MRD‡‡
Patient response | n | Median OS | 95% CI |
MRD responders at cycle 1 | 84 | NR | 29.5–NR |
MRD nonresponders at cycle 1 | 23 | 14.4 months | 3.8–32.3 |
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131:1522-1531. 3. Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-precursor acute lymphoblastic leukemia. Blood. 2018;131(suppl):1522-1531. 4. Gökbuget N, Zugmaier G, Dombret H, et al. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020;61:2665-2673. 5. Data on file, Amgen; 2018. 6. Food and Drug Administration. BLINCYTO® (blinatumomab) for minimal residual disease positive (MRD+) B-cell precursor acute lymphoblastic leukemia (ALL). https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM603411.pdf. Accessed June 30, 2021. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia v.2.2021. National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 22, 2021. 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. 8. Keating AK, Gossai N, Phillips CL, et al. Reducing minimal residual disease with blinatumomab prior to HCT for pediatric patients with acute lymphoblastic leukemia. Blood Adv. 2019;3:1926-1929. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia v.3.2021. National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 22, 2021. 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.
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