CR/CRh*/
CRi rates of
44%
(n=119/271)
(95% CI: 37.9–50.0)
BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
Study design: 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 Selected secondary endpoints: CR within 12 weeks after initiation of treatment, CR/CRh*/CRi within 12 weeks after initiation of treatment, MRD remission rate, duration of remission, adverse event rates.2
BLINCYTO® is the only immunotherapy to deliver superior OS and deep, durable remission vs SOC chemotherapy in adult patients with Ph(–) R/R B-cell precursor ALL
†A censored subject is indicated by a vertical bar.1
ALL, acute lymphoblastic leukemia; CI, confidence interval; CR, complete remission; DOR, duration of response; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; mOS, median overall survival; MRD, measurable or minimal residual disease; NCCN, National Comprehensive Cancer Network; OS, overall survival; Ph(–), Philadelphia chromosome-negative; QoL, quality of life; R/R, relapsed or refractory; SOC, standard-of-care.
‡OS in patients treated in first salvage was a prespecified subgroup analysis in TOWER; however, the OS efficacy in this subgroup was not a study objective and the study was not powered to assess OS efficacy in this subgroup.4
§A censored subject is indicated by a vertical bar.3
NR, not reached.
**OS in patients censored for allogeneic transplant was a prespecified sensitivity subgroup analysis in TOWER; however, the OS efficacy in this subgroup was not a study objective, and the study was not powered to assess OS efficacy in this subgroup.4
CR/CRh*/
CRi rates of
44%
(n=119/271)
(95% CI: 37.9–50.0)
for patients treated with
BLINCYTO®
vs 25%
(n=33/134)
(95% CI: 17.6–32.8)
for patients treated with SOC chemotherapy2
(P
< 0.001)
Median duration of response for patients who achieved CR/CRh*/CRi2
††CR was defined as ≤ 5% blasts in the BM, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microliter and ANC > 1,000/microliter). CRh* was defined as ≤ 5% blasts in the BM, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microliter and ANC > 500/microliter). CRi was defined as ≤ 5% blasts in the BM, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microliter or ANC > 1,000/microliter).2
ANC, absolute neutrophil count; BM, bone marrow; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery.
74%
(n=20/27)
of patients achieved a best response of complete remission during continued therapy
CRS, cytokine release syndrome.
BLINCYTO®
76%
(n=90/119)
vs SOC chemotherapy (n=16/33): 48%
‡‡Molecular remission was assessed in patients achieving CR/CRh*/CRi, and was defined as MRD by PCR or flow cytometry with a minimum assay sensitivity2 of < 1 x 10-4.
PCR, polymerase chain reaction.
Mean changes in HRQoL functional domains and symptoms at the end of Cycle 1 (Day 29)6
Click here for the EORTC QoL Questionnaire from the TOWER Study9
§§The PRO instrument—The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)—is a validated self-rating questionnaire used to assess patients’ perceptions of treatment effectiveness in oncology.7
AE, adverse event; HRQoL, health-related quality of life; PRO, patient-reported outcome.
Prephase treatment:
Premedication:
Primary endpoint:2
Selected secondary endpoints:2
Key inclusion criteria 1,2 |
---|
Patients ≥ 18 years of age |
Ph(–) R/R B-cell precursor ALL occurring as refractory to primary induction therapy or to last therapy, or untreated first relapse (first remission duration < 12 months), or in second or later relapse, or in any relapse after HSCT |
With > 5% blasts in the BM and ECOG PS ≤ 2 |
Key exclusion criteria 2 |
Other active cancers |
Clinically relevant pathologic condition of the CNS |
Isolated extramedullary disease |
Autoimmune disease |
Acute GvHD of Grade ≥ 2, active chronic GvHD |
Allogeneic stem cell transplantation within 12 weeks before randomization |
Autologous stem cell transplantation within 6 weeks before randomization |
Chemotherapy or radiotherapy within 2 weeks before randomization |
Use of immunotherapy within 4 weeks before randomization |
Ongoing use of investigational treatment |
BLINCYTO® was studied in a wide range of adult patients, including those with a poor prognosis2
BLINCYTO ® (N=271) |
SOC Chemotherapy (N=134) | |
Age | ||
Mean ± SD, years | 41 ± 17 | 41 ± 17 |
Range, years | 18–80 | 18–78 |
Study entry criteria, n (%) | ||
Refractory to primary or salvage therapy | 115 (42) | 54 (40) |
In early first relapse (CR1 duration < 12 months) | 76 (28) | 37 (28) |
In untreated second or later relapsea | 32 (12) | 16 (12) |
Relapsed after HSCT a | 46 (17) | 27 (20) |
Not specified | 2 (1) | 0 |
Prior salvage therapy, n (%) | 171 (63) | 70 (52) |
Prior transplant, n (%) | ||
Yes | 94 (35) | 46 (34) |
No | 176 (65) | 87 (65) |
Unknown | 1 (0) | 1 (1) |
Disease burden, n (%) | ||
≥ 50% BM blasts | 201 (74) | 104 (78) |
A majority of patients in a study of real-world evidence were high-risk with unfavorable risk cytogenetic abnormalities12
Ph(+), Philadelphia chromosome–positive; TKI, tyrosine kinase inhibitor.
Median OS12
(n=158)
CR/CRi
rates of
57%
(n=86/151)
for patients on
BLINCYTO®
Median DOR for patients who achieved CR/CRi12,§§§§
for patients treated with BLINCYTO®
(n=86)
Duration of response by tumor burden12
MRD response
78%
(n=65/83)
for patients
in CR treated
with
BLINCYTO®
Proceeded to HSCT12
for all patients treated with BLINCYTO®
(n=71/159)
Baseline characteristics (n=159)12
Age | |
---|---|
Mean ± SD, years | 45 ± 17 |
Range, years | 8–79 |
Study entry criteria, n (%) | |
Refractory to primary therapy | 41 (26.6) |
< 18 months to first progression | 76 (49.4) |
Cytogenetic abnormalities, n (%) | |
No | 62 (39.0) |
Yes | 97 (61.0) |
≥ 3 previous therapies, n (%) | 36 (22.8) |
Prior transplant, n (%) | |
Yes | 27 (17.0) |
No | 132 (83.0) |
BM blasts at initiation of BLINCYTO®, n (%) | |
BM blasts ≥ 50%, n (%) | 57 (45.2) |
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
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847. 3. Dombret H, Topp MS, Schuh A, et al. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019;60:2214-2222. 4. Data on file, Amgen; [1], 2014. 5. Rambaldi A, Huguet F, Zak P, et al. Maintenance therapy with blinatumomab in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia: overall survival in adults enrolled in a phase 3 open-label trial. Presented at: 59th ASH Annual Meeting and Exposition; December 9–12, 2017; Atlanta, GA. Abstract 2552 6. Topp MS, Zimmerman Z, Cannell P, et al. Health-related quality of life (HRQoL) of blinatumomab versus standard of care (SOC) chemotherapy in patients with relapsed or refractory Philadelphia negative B-cell precursor acute lymphoblastic leukemia in a randomized, open-label phase 3 study (TOWER). Blood. 2016;128:222. 7. Data on file, Amgen; 2017. 8. Data on file, Amgen; 2016. 9. European Organisation for Research and Treatment of Cancer. EORTC QLQ-C30 (version 3). https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-QLQ-C30-English.pdf. Accessed July 5, 2022. 10. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(suppl):836-847. 11. 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 April 4, 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. 12. Data on file, Amgen; 2021.