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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 PHASE 2 STUDY DESIGN

Phase 2, open-label, multicenter, single-arm clinical trial, N=185 patients1

INCLUSION CRITERIA1:
  • Age ≥ 18 years

  • Ph-negative R/R B-precursor ALL

    • Early relapse (duration of first remission ≤ 12 months) OR

    • Any relapse or refractory disease after first salvage therapy OR

    • Relapse within 12 months of allogeneic HSCT AND

    • ≥ 10% blasts in bone marrow

EXCLUSION CRITERIA1:
  • Late relapse patients (a CR lasting for > 12 months)

STUDY ENDPOINTS1-3

Primary Secondary Included Exploratory
CR/CRh* within the first 2 cycles of treatment
  • CR

  • CRh*

  • Duration of response (DOR)/relapse-free survival (RFS)

  • HSCT realization

  • Incidence of adverse reactions

Minimal residual disease (MRD) response was defined as MRD by polymerase chain reaction (PCR) < 1x10-4
Endpoint assessment was determined by bone marrow biopsies/MRD testing (every 28 days)
TREATMENT CYCLES1-3

Patients received 2 cycles of induction treatment followed by 3 additional cycles of BLINCYTO® consolidation treatment (up to a total of 5 cycles).1

ADMINISTRATION: Continuous intravenous infusion

treatment cycles
BLINCYTO® (blinatumomab) Clinical Study Treatment Cycles
CR (complete remission) was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease; and full recovery of peripheral blood counts (platelets > 100,000/microliter and absolute neutrophil counts [ANC] > 1,000/microliter).1
CRh* (complete remission with partial hematological recovery) was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microliter and ANC > 500/microliter).1
DOR (duration of response)/RFS (relapse-free survival) was defined as time since first response of CR or CRh* to relapse or death, whichever is earlier.1
Patients who did not achieve a CR/CRh* by the end of cycle 2 were excluded from continuing therapy.2
STUDY POPULATION
Baseline Patient Characteristics1,4,5
PATIENTS IN CLINICAL TRIAL (N=185) n (%)
Male, n (%) 116 (63)
Median (range in age, years) 39 (18-79)
Age Group, n (%)
18 to < 35 years 87 (47)
35 to < 55 years 45 (24)
55 to < 65 years 28 (15)
≥ 65 years 25 (14)
Prior Salvage therapy, n (%)
None 35 (19)
1 77 (42)
2 41 (22)
> 2 32 (17)
Prior allogeneic HSCT, n (%) 63 (34)
Bone marrow blast count, n (%)
< 10% 9 (5)
10% to < 25% 18 (10)
25% to < 50% 31 (17)
50% to < 75% 25 (14)
≥ 75% 102 (55)

KEY INSIGHTS
  • 81% (n=150/185) of patients were receiving second salvage or later once in the study5

  • 14% (n=25/185) of patients were ≥ 65 years of age4

  • 34% (n=63/185) of the patients had prior HSCT1

  • 69% (n=127/185) of patients had ≥ 50% blasts5

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References:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.
  2. Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16:57-66.
  3. Topp MS, Goekbuget N, Stein AS, et al. Oral abstract #7005 presented at: American Society of Clinical Oncology 2014 Annual Meeting; May 30-June 3, 2014; Chicago, IL.
  4. Data on file, Amgen; [Clinical Overview]; 2014.
  5. Data on file, Amgen; [Baseline Characteristics]; 2016.