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

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

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†,‡

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Intervening with BLINCYTO® in first salvage more than doubled median OS vs SOC chemotherapy2,§

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Deep and durable remission was demonstrated in patients treated with BLINCYTO®3,**

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The most common AEs (≥ 20%) in the BLINCYTO® arm were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia1

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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 ALL4

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In a real-world evidence study, the observed efficacy of BLINCYTO® was reflective of clinical study data1,3,5,††

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†The prespecified primary endpoint of overall survival was met in the landmark phase 3 TOWER study of BLINCYTO® vs chemotherapy.3

‡CR/CRh*/CRi within 12 weeks after initiation was 44% for BLINCYTO® (n=119/271) vs 25% for chemotherapy (n=33/134); P < 0.001; mDOR was 7.3 months for BLINCYTO® (n=119/271; 95% CI: 5.8–9.9) and 4.6 months for chemotherapy (n=33/134; 95% CI: 1.8-19.0); MRD(–) rate was 76% for BLINCYTO® (n=90/119) vs 48% for chemotherapy (n=16/33).1,3

§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.6

**CR was defined as ≤ 5% blasts in the bone marrow, 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 bone marrow, 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 bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microliter or ANC > 1,000/microliter).3

††Five patients who could not titrate to the full dose due to tolerance were included in the analysis.5

Pediatric data

BLINCYTO® has a growing body of evidence as a treatment for pediatric and AYA patients in first relapse of CD19-positive B-cell precursor ALL1,7,8

MT103-205 and TOWER provided the foundation for the FDA approval of the R/R CD19-positive B-cell precursor ALL indication of BLINCYTO® in the pediatric/AYA population1,3,9

MT103-205: international, open-label, single-arm, phase 1/2 study of single-agent BLINCYTO® in patients < 18 years of age with > 25% BM blasts who were primary refractory, in first relapse after full salvage induction, in second or later relapse, or in any relapse after HSCT. Primary endpoint was CR/CRh* in first 2 cycles: 33% (n=23/70); (95% CI: 22.1-45.1.)‡‡ Most common AEs: pyrexia, anemia, nausea, and headache. Dosing: cIV infusion (4 weeks on, 2 weeks off). Phase 1: dose finding. Phase 2 dosing: 5/15 mcg/m2/day (5 mcg/m2/day [first week, cycle 1] followed by 15 mcg/m2/day thereafter)1,9

‡‡CR was defined as ≤ 5% of blasts in the BM, no evidence of circulating blasts or EM disease, and full recovery of PB counts (platelets > 100,000/microliter and ANC > 1,000/microliter. CRh* was defined as ≤ 5% of blasts in the BM, no evidence of circulating blasts or EM disease, and partial recovery of PB counts (platelets > 50,000/microliter and ANC > 500/microliter).1

Amgen 20120215 study

Study design: A randomized, controlled, open-label, phase 3 study of BLINCYTO® vs chemotherapy as post-reinduction consolidation therapy prior to HSCT in 108 pediatric patients > 28 days and < 18 years of age with Ph(–) B-cell precursor ALL in high-risk first relapse.§§ After receiving reinduction chemotherapy followed by 2 blocks of high-risk consolidation chemotherapy,*** patients were randomized to receive one cycle of BLINCYTO® (n=54) or a third block of high-risk consolidation chemotherapy (n=54).††† Primary endpoint was EFS: 66% at 2 years for patients on BLINCYTO® (n=54) vs 27% for patients receiving chemotherapy (n=54); P < 0.001; HR: 0.33 (95% CI: 0.18–0.61).7

Amgen 20120215 study is not in the USPI but was deemed to be consistent with the label for BLINCYTO® use in relapsed or refractory CD19-positive B-cell precursor ALL for the pediatric population.

BLINCYTO® demonstrated superior EFS and improved OS vs chemotherapy in pediatric patients with B-cell precursor ALL in high-risk first relapse7,10

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BLINCYTO® converted most patients to MRD(–)‡‡‡ and more patients proceeded to HSCT vs chemotherapy7

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The most common AEs (≥ 20%) in the BLINCYTO® arm were pyrexia, nausea, headache, stomatitis, vomiting, anemia, erythema/rash, thrombocytopenia, and diarrhea10

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§§High risk was defined as very early or early iBM relapse, very early combined BM + EM relapse, or very early iEM relapse. Very early relapse was defined as < 18 months after primary diagnosis, and early relapse was defined as ≥ 18 months after primary diagnosis and < 6 months after completion of primary therapy.11

***Induction therapy and cycles of HC1 and HC2 chemotherapy administered according to the IntReALL HR 2010, ALL-REZ BFM 2002, ALL R3, COOPRALL, and AIEOP ALL REC 2003 protocols.7

†††Third block of consolidation chemotherapy, HC3, included: dexamethasone IV/ vincristine IV/ daunorubicin IV/ methotrexate IV/ ifosfamide IV/ PEG-asparaginase IV/IM.7,10

‡‡‡MRD 10–4 evaluated in a central laboratory by PCR.7

COG AALL1331 study

Study design: A randomized, controlled, open-label, phase 3 study of 208 patients 1–27 years of age with Ph(–) B-cell precursor ALL in high-risk§§§ or intermediate-risk first relapse of B-cell precursor ALL.****,†††† Following one UKALLR3 reinduction chemotherapy block, patients in the high-risk and intermediate-risk groups were randomized to receive cycles 1 and 2 of BLINCYTO® (n=105) as post-reinduction consolidation therapy or blocks 2 and 3 of chemotherapy consolidation (n=103) based on the UKALLR3 trial.‡‡‡‡ The primary endpoint was DFS: 54% at 2 years for patients receiving BLINCYTO® (n=105) vs 39% for patients receiving chemotherapy (n=103); P = 0.03; HR: 0.70 (95% CI: 0.47–1.03).8,12,13

COG AALL1331 study is not in the USPI but was deemed to be consistent with the label for BLINCYTO® use in relapsed or refractory CD19-positive B-cell precursor ALL for pediatric and AYA populations.

BLINCYTO® demonstrated improved DFS and OS vs chemotherapy for high-risk and intermediate-risk pediatric and AYA patients in first relapse8,§§§,****

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More patients achieved an MRD response and proceeded to HSCT with BLINCYTO® vs chemotherapy8

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  • MRD response was an exploratory endpoint. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn8

The most common AEs of any grade (≥ 20%) in the BLINCYTO® cycle 1 or cycle 2 treatment arms were anemia, decreased WBC, increased alanine aminotransferase, fever, decreased neutrophil count, increased aspartate aminotransferase, hypoalbuminemia, decreased lymphocyte count, decreased platelet count, hyperglycemia, hypocalcemia, hypokalemia, and infection8

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§§§Patients who had an iBM or combined BM + EM relapse < 36 months or who had an iEM relapse < 18 months were assigned to the high-risk group.8

****Patients who had an iBM or combined BM + EM relapse ≥ 36 months or who had an iEM relapse ≥ 18 months and MRD ≥ 0.1% at end of induction were assigned to the intermediate-risk group.8

††††A low-risk randomization arm was also part of the study.8

‡‡‡‡UKALLR3: induction, IT methotrexate/dexamethasone oral/mitoxantrone IV or idarubicin IV/vincristine IV/pegaspargase IM; consolidation, dexamethasone oral/vincristine IV/IT methotrexate/methotrexate IV/pegaspargase IM/cyclophosphamide IV/etoposide IV; maintenance, IT methotrexate/dexamethasone oral/vincristine IV/cytarabine IV/Erwinase IM/methotrexate IV; before HSCT, fludarabine IV/cytarabine IV/liposomal daunorubicin citrate IV.8,13,14

AE, adverse event; ALL, acute lymphoblastic leukemia; ANC, absolute neutrophil count; AYA, adolescent and young adult; CD, cluster of differentiation; CI, confidence interval; COG, Children’s Oncology Group; CR, complete remission; CRh*, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; DFS, disease-free survival; EFS, event-free survival; 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; PCR, polymerase chain reaction; R/R, relapsed or refractory; SOC, standard-of-care.

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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.

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. 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. 3. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847. 4. 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. 5. Data on file, Amgen; 2021. 6. Data on file; Amgen; [1]; 2014. 7. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:843-854. 8. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:833-842. 9. von Stackelberg A, Locatelli F, Zugmaiger G, et al. Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol. 2016;34:4381-4389. 10. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia. JAMA. 2021;325(suppl 3):843-854. 11. Data on file, Amgen; 2020. 12. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia. JAMA. 2021;325(suppl 1):833-842. 13. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia. JAMA. 2021;325(suppl 2):833-842. 14. Parker C, Waters R, Leighton C, et al. Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukemia (ALL R3): an open-label randomised trial. Lancet. 2010;376:2009-2017.

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