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Indication
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BLINCYTO® (blinatumomab) is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
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Indication
BLINCYTO® (blinatumomab) for injection 35 mcg single-use vial
CLINICAL DATA FOR PATIENTS
AGE < 18 YEARS
BLINCYTO® (blinatumomab) PIVOTAL STUDY DESIGN

Open-label, single-arm, multicenter phase 1/2 study1,2

KEY INCLUSION CRITERIA:
  • B-precursor ALL > 25% blasts in bone marrow

  • Age < 18 years

  • ALL that is primary refractory disease, in first relapse after full salvage induction regimen, in second or later bone marrow relapse, or in any marrow relapse after HSCT, or refractory to other treatments

  • KPS ≥ 50% for patients ≥ 16 years of age or LPS of ≥ 50% for patients < 16 years of age

KEY EXCLUSION CRITERIA:
  • Active acute or extensive chronic GVHD

  • Evidence of current CNS involvement of ALL

  • Evidence of active testicular involvement of ALL

STUDY ENDPOINTS

The primary endpoint was the rate of M1 bone marrow (<5% blasts in the marrow) with no evidence of circulating blasts or extra-medullary disease within the first 2 cycles of BLINCYTO® treatment.

Efficacy Evaluation Other Efficacy Evaluations MRD Response Rate
Efficacy was evaluated using complete remission/ complete remission with partial hematological recovery (CR/CRh)†‡ rate within the first 2 cycles of BLINCYTO® treatment HSCT realization, overall survival, relapse-free survival, incidence, and severity of adverse events MRD response rate (conversion to MRD negativity§ within the first 2 treatment cycles)
TREATMENT CYCLES1,2

ADMINISTRATION: Continuous intravenous (cIV) infusion

treatment cycles
treatment cycles

Patients who achieved CR within 2 cycles of induction therapy were allowed to receive up to 3 additional cycles of consolidation therapy.

CR (complete remission) was defined as ≤ 5% of blasts in the bone marrow, no evidence of circulating blasts or extra-medullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microliter and absolute neutrophil counts [ANC] > 1,000/microliter).
CRh* (complete remission with partial hematological recovery) was defined as ≤ 5% of blasts in the bone marrow, no evidence of circulating blasts or extra-medullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microliter and ANC >500/microliter).
§MRD response was a prespecified exploratory endpoint, and was defined as < 1 x 10-4 detectable blasts as determined by flow cytometry or PCR.
CNS, central nervous system; GVHD, graft-versus-host disease; HSCT, hematopoietic stem cell transplantation; KPS, Karnofsky performance status; LPS, Lansky performance status; MRD, minimal residual disease; PCR, polymerase chain reaction.
STUDY POPULATION
Baseline Patient Characteristics1,2
TREATED POPULATION (N=70) n (%)
Male, n (%) 47 (67)
Median (range in age, years) 8 (7 months to 17 years)
Age Group, n (%)
< 2 years 10 (14)
2-6 years 20 (29)
7-17 years 40 (57)
Number of refractory patients 39 (56)
Number of prior relapses||
0 (primary refractory disease) 2 (3)
1 31 (44)
2 29 (41)
≥ 3 8 (11)
Prior HSCT, n (%) 40 (57)
Baseline bone marrow blast (central lab)
< 50% 18 (26)
≥ 50% 52 (74)

||Includes relapse during which subject entered the study.

KEY INSIGHTS
  • 56% (n=39/70) had refractory disease at study entry

  • 74% (n=52/70) had a high tumor burden (≥ 50% baseline bone marrow blasts)

  • 52% (n=37/70) were in second or later relapse

  • 57% (n=40/70) had relapsed after HSCT

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References:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.
  2. von Stackelberg A, Locatelli F, Zugmaier G, et al. Phase I/Phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol. 2016; epub ahead of print, October 3, 2016. doi:10.1200/JCO.2016.67.3301.