Indication

BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

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Intervene earlier—for all that’s ahead

The TOWER landmark study

BLINCYTO® is the first and only immunotherapy to deliver superior OS and deep and durable remission vs SOC chemotherapy in adult patients with Ph(–) R/R B-cell precursor ALL

  • TOWER landmark phase 3 study: BLINCYTO® single-agent immunotherapy was compared with chemotherapy in a large, international, prospective, randomized, controlled, phase 3 trial of 405 patients with Ph(–) relapsed/refractory B-cell precursor ALL1
2
2:1
Randomization2
1
BLINCYTO® single-agent immunotherapy (n=271)1
  • Continuous IV infusion for 1 to 2 induction cycles (4 weeks on, 2 weeks off)2
  • 9 mcg/day on days 1–7 of cycle 1 and 28 mcg/day on subsequent days2
Standard-of-care chemotherapy (investigator's choice of one of the regimens below) (n=134)1
  • FLAG ± anthracycline-based regimen
  • HiDAC-based regimen
  • High-dose methotrexate-based regimen
  • Clofarabine-based regimen
Consolidation, maintenance,† and follow-up, depending on response to induction2
2
2:1
Randomization2
1
BLINCYTO® single-agent immunotherapy (n=271)1
  • Continuous IV infusion for 1 to 2 induction cycles (4 weeks on, 2 weeks off)2
  • 9 mcg/day on days 1–7 of cycle 1 and 28 mcg/day on subsequent days2
Standard-of-care chemotherapy (investigator's choice of one of the regimens below) (n=134)1
  • FLAG ± anthracycline-based regimen
  • HiDAC-based regimen
  • High-dose methotrexate-based regimen
  • Clofarabine-based regimen
Consolidation, maintenance,† and follow-up, depending on response to induction2

†Maintenance as defined by the study protocol: Patients achieving ≤ 5% BM blasts could continue with BLINCYTO® as maintenance therapy for an additional 12 months (4 weeks on, 8 weeks off).2

Primary endpoint:2

  • OS

Selected secondary endpoints:2

  • 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
Key inclusion criteria1,2
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 criteria2
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

Baseline characteristics of the study population1,2

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)
3 out of 4
patients had high tumor burden2

aPatients who met this study entry criterion met none of the above study entry criteria.2

  • Patients in late first relapse (≥ 12 months after initial remission) were excluded2

ALL, acute lymphoblastic leukemia; BM, bone marrow; CI, confidence interval; CNS, central nervous system; CR, complete remission; CR1, first complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; ECOG PS, Eastern Cooperative Oncology Group performance score; FLAG, fludarabine, cytarabine, granulocyte colony-stimulating factor; GvHD, graft versus host disease; HiDAC, high-dose cytarabine; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; ITT, intent-to-treat; IV, intravenous; MRD, measurable or minimal residual disease; OS, overall survival; Ph(–), Philadelphia chromosome–negative; R/R, relapsed or refractory; SD, standard deviation; SOC, standard-of-care.

BLINCYTO® nearly doubled median overall survival vs SOC chemotherapy1

Primary endpoint: Overall survival (intent-to-treat population)1

‡A censored subject is indicated by a vertical bar.1

Intervening in first salvage with BLINCYTO® more than doubled median OS vs SOC chemotherapy3,§

OS in patients treated in first salvage3,§

§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.

Patients receiving BLINCYTO® achieved higher rates and longer duration of remission vs SOC chemotherapy2,††

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 chemotherapy2 P < 0.001

Median duration of response for patients who achieved CR/CRh*/CRi2

  • CR/CRh*/CRi rates achieved within 12 weeks after treatment initiation2
  • 53% (n=60/114) of patients in first salvage treated with BLINCYTO® achieved CR/CRh*/CRi2
    • CR/CRh*/CRi in patients treated in first salvage was a prespecified subgroup analysis in TOWER; however, the CR/CRh*/CRi in this subgroup was not a study objective and the study was not powered to assess efficacy in this subgroup

††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.

Patients treated with BLINCYTO® had higher MRD negativity rates‡‡ than patients treated with SOC chemotherapy2

MRD negativity rates for patients who achieved CR/CRh*/CRi with BLINCYTO® vs SOC chemotherapy2

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.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend blinatumomab (BLINCYTO®) as a Category 1 therapy option for patients with Ph(–) R/R B-cell precursor ALL5

Real-world evidence study

In a real-world evidence study, the observed efficacy of BLINCYTO® was reflective of clinical study data6,§§

A majority of patients in a study of real-world evidence were high-risk with unfavorable risk cytogenetic abnormalities6

  • These data are derived from a retrospective, multicenter study of 239 patients across 11 academic centers in the US, of which 190 selected patients were identified as starting with standard BLINCYTO® dosing and no concomitant treatments (eg, TKI, chemotherapy, rituximab, or any combination of these):6
    • Patients who did not receive BLINCYTO® for Ph(–) R/R B-cell ALL consistent with the FDA labeling were excluded in this subset analysis
    • Of the 190 patients included in this subset analysis, 159 had Ph(–) R/R B-cell ALL. The remaining 31 patients had Ph(+) R/R B-cell ALL and are excluded from this data presentation
  • Medical records were reviewed to collect demographic, patient-related, disease-related, and clinical outcome data6
  • Patients were evaluated for OS (from the time of BLINCYTO® initiation), CR, DOR, MRD response, cumulative incidence of HSCT, and adverse events:6
    • OS was estimated from the time of BLINCYTO® treatment initiation to death or lost to follow-up
    • CR was defined as ≤ 5% BM blasts, no evidence of disease in the BM, and recovery of peripheral blood count (platelet count > 100,000/µl and ANC > 1,000/µl)
    • DOR was estimated among patients achieving a CR/CRi after BLINCYTO® from time of CR/CRi to progression or death
    • MRD was assessed with the use of multicolor flow cytometry
    • The cumulative incidence of HSCT was estimated using the Nelson-Aalen estimate with death without HSCT as competing risk

Baseline characteristics (n=159)6

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)
~ 45%
of patients had ≥ 50% bone marrow blasts

In the real-world evidence study, OS was observed in patients who received BLINCYTO®6,***,†††

Median OS6

9.2 months

(n=158)

  • Median follow-up of 18 months6
  • Median OS was 9.1 months among patients with ≥ 50% BM blasts at initiation of BLINCYTO®6

In the real-world evidence study, responses were observed in patients who received BLINCYTO®6,‡‡‡,§§§

CR/CRi
rates of

57%

(n=86/151)
for patients on
BLINCYTO®

Median DOR for patients who achieved CR/CRi6,****

19.6 months

for patients treated with BLINCYTO®

(n=86)

Duration of response by tumor burden6

BM blasts at initiation of BLINCYTO® Median DOR DOR at year 2
< 50% NR 52.6%
≥ 50% 19.4 months 44.3%

In the real-world evidence study, the majority of patients in CR achieved MRD negativity with BLINCYTO®, and nearly half of all patients proceeded to HSCT6,‡‡‡

MRD response

78%

(n=65/83) for patients
in CR treated
with BLINCYTO®

Proceeded to HSCT6

45%

for all patients treated with BLINCYTO®

(n=71/159)

  • MRD was assessed using flow cytometry in this analysis vs. flow cytometry and PCR in the TOWER study. Additionally, the timing of when MRD and CR was assessed was not specified. In the TOWER study, patients were assessed for these endpoints within 12 weeks of treatment initiation.

Real-world evidence provides additional data outside of a clinical trial that may support the choice of BLINCYTO® in adults with Ph(–) R/R B-cell precursor ALL6

§§Five patients who could not titrate to the full dose due to tolerance were included in the analysis.6

***One patient did not have data available for the survival analysis and is not included in the survival analyses. However, note that this patient is included in the toxicity and response evaluations.6

†††Estimated from the time of BLINCYTO® treatment initiation to death or lost to follow-up.6

‡‡‡The exact assessment timing was not specified for this endpoint.6

§§§Data were missing for 8 patients in this analysis.6

****Adjusted for HSCT.6

DOR, duration of response; NCCN, National Comprehensive Cancer Network; TKI, tyrosine kinase inhibitor.

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; December 2014.
  5. 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 September 20, 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.
  6. Data on file, Amgen; June 2021.

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IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications

BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions
  • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in 15% of patients with R/R ALL and in 7% of patients with MRD-positive ALL. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
  • Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life‐threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
  • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
  • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
  • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
  • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
  • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and TBILI prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
  • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
  • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
  • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
  • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
  • Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including “gasping syndrome,” which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO® (with preservative). When prescribing BLINCYTO® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.
Adverse Reactions
  • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO® were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
  • Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adults with relapsed or refractory B-cell precursor ALL were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
  • In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).
Dosage and Administration Guidelines
  • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
  • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
INDICATION
  • BLINCYTO® is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.

BLINCYTO® is a registered trademark of Amgen Inc.

See more

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
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