Acute Lympohoblastic Leukaemia (ALL) is a rare disease, with around 300 new adult cases diagnosed in the UK each year2
The E1910 randomised controlled trial added blinatumomab to standard of care consolidation chemotherapy, and compared this with consolidation chemotherapy alone, in adult patients with Philadelphia chromosome negative CD19-positive B-cell precursor acute lymphoblastic leukaemia, who were minimal residual disease (MRD) negative3
The results showed at a median follow up of 4.5 years, in the blinatumomab treatment group there was significantly improved overall survival, with a 56% reduction in the risk of death for the primary endpoint (Hazard ratio 0.44, 95% confidence interval 0.25 - 0.76, p=0.003)1
CAMBRIDGE, UK (December 17, 2024) – Today, Amgen announced the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has licensed an indication extension to blinatumomab for the treatment of adult patients with Philadelphia chromosome negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase. Consolidation is a phase of frontline treatment for ALL patients, which takes place after the induction phase. Although most patients are in remission after induction treatment, there is an unmet need for targeted treatments that reduce the number of remaining leukaemia cells that could cause a subsequent relapse.
This indication extension means adult patients with Philadelphia chromosome negative CD19-positive B-ALL can now receive blinatumomab in the consolidation phase added to standard of care chemotherapy.
“B-cell precursor leukaemia acute lymphoblastic leukaemia (B-ALL) is a rare life-threatening blood cancer. Patients treated with standard of care chemotherapy alone in consolidation, can relapse despite initial responses and hence the E1910 trial investigated whether adding blinatumomab to the standard of care chemotherapy regimen could prolong survival and reduce relapse rates. The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse,” said Tony Patrikios, Amgen UK & Ireland Medical Director.
The extended indication is based on the Phase 3 E1910 clinical trial, led by ECOG-ACRIN Cancer Research Group. This randomised-controlled trial studied adult patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving post-induction consolidation treatment.3
“In the E1910 study, blinatumomab added to consolidation chemotherapy, demonstrated significantly improved survival compared to chemotherapy alone in patients who met the threshold of MRD negativity below 10-4,” said Dr Richard Burt, Cancer Research UK Clinician Scientist at Imperial College London and Honorary Haematology Consultant at University College London Hospital. “This licence could provide a more effective treatment option compared to standard of care chemotherapy alone for minimal residual disease negative adult patients with B-ALL, by reducing likelihood of relapse and improving survival."
Results from the study demonstrated that in adult patients with Philadelphia chromosome negative CD19-positive B-ALL who are MRD negative (threshold below 10-4), blinatumomab added to multiphase consolidation chemotherapy showed improved overall survival (OS, primary endpoint) and relapse free survival (RFS, secondary endpoint) versus consolidation chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the blinatumomab plus chemotherapy arm and 62.5% in the chemotherapy arm, with the hazard ratio for OS of 0.44 (95% confidence interval 0.25 - 0.76) (p=0.003). The 5-year RFS was 77% in the blinatumomab plus chemotherapy arm versus 60.5% in the chemotherapy arm, with a hazard ratio for RFS of 0.53 (95% CI, 0.32 - 0.88).1
"This randomised controlled trial, involving a relatively large number of patients for this rare disease, demonstrates that adding blinatumomab alongside standard of care consolidation chemotherapy had a generally manageable safety profile. The safety data was consistent with the known profile of the medicine," said Dr Tobias Menne, Consultant Haematologist and Clinical Director for Research at the Newcastle Upon Tyne Hospitals NHS Foundation Trust.
Blinatumomab Summary of Product Characteristics
For further information about blinatumomab, the summary of product characteristics (SmPC), including a full list of side effects and adverse reactions, is available here: https://www.medicines.org.uk/emc/product/5064/smpc#about-medicine
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NOTES TO EDITORS
About the E1910 Study
ECOG-ACRIN sponsored the trial with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. Amgen provided blinatumomab and support through an NCI Cooperative Research and Development Agreement.
About B-cell Acute Lymphoblastic Leukaemia (ALL)
ALL, also known as acute lymphoblastic leukaemia, is a type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system.4 ALL is a rare disease, with around 300 new adult cases diagnosed in the UK each year.2 B-cell ALL is a disease of immature B cells, where immature white blood cells grow rapidly in bone marrow.4 B-cell ALL is the most common type of ALL in adults, constituting approximately 75% of cases in adults.5
About blinatumomab
Blinatumomab is a type of targeted cancer drug. It is an immunotherapy treatment for B-cell precursor acute lymphoblastic leukaemia. Blinatumomab is a bispecific T-cell engager molecule (or BiTE molecule) that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. Blinatumomab mediates the formation of a cytolytic synapse between the T cell and the tumour cell, releasing proteolytic enzymes to kill both proliferating and resting target cells. For the treatment of CD19-positive B-cell precursor ALL in the consolidation phase, hospitalisation is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle 1
References
GBR-757-1224-80005 | December 2024