Acute lymphocytic leukaemia (ALL) is a rare blood cancer with an incidence of just over 5,500 patients in the US, both paediatric and adult. ALL is classified as either B-ALL (more common) and T-ALL, with T-ALL having a far more dismal prognosis. Decades of intensive chemotherapy research have yielded substantial cure rates with intensive chemotherapy regimens in paediatric patients, and a lower cure rate but improved five-year survival rates in adult patients.
For relapsed/refractory (R/R) patients, the prognosis is universally poor, and even poorer in the rarer T-ALL subset. Chemotherapy regimens vary wildly depending on the country and institution, but in younger patients, they involve a combination of asparaginase products + chemotherapy, whereas in older patients it is typically chemotherapy only, such as the well-established hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) regimen. Upon relapse, one of the most common options for B-ALL patients is Amgen’s bispecific CD19/CD3 T-cell engager Blincyto (blinatumomab), which received FDA approval for R/R patients in 2014. Blincyto received a label expansion from the FDA in 2018 for use in patients with minimal residual disease (MRD)-positive status after intensive chemotherapy in the first line.
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At the 64th American Society of Haematology (ASH) Annual Meeting and Exposition on 10–13 December, new data were presented from the randomised Phase III ECOG-ACRIN E1910 study of Blincyto in the first line for MRD-negative patients (abstract #LBA-1). Patients had to be negative for the BCR-ABL1 translocation and were aged between 30 and 70 years. Patients (n=224) were taken to MRD-negative status with a BFM-like, adapted chemotherapy regimen that could also include asparaginase and rituximab (chemo) depending on patient characteristics, and were then randomised to receive either chemo-based consolidation or chemo + Blincyto-based consolidation, n=112 in each arm.
Patients that did not achieve remission (19%) were taken off the study protocol. The primary endpoint was overall survival (OS), and stem cell transplant was allowed for both arms at investigators’ discretion; 22 patients in each arm received an allogeneic transplant. At a median follow-up of 43 months, the median OS was not reached for the Blincyto arm versus 71.4 months for the chemotherapy arm (hazard ratio [HR]: 0.42). No new safety signals were reported.
A large improvement in OS for newly-diagnosed adult B-ALL patients has not been demonstrated in years. As such, this trial makes a combination of a chemotherapy regimen + Blincyto the new standard of care for newly diagnosed B-ALL BRC-ABL1-negative patients of ages 30 to 70 years who achieve a complete remission regardless of MRD status. Since the trial was led by the National Cancer Institute, it is very likely that the data will allow for a supplemental biologics license application by Amgen for a label expansion.
The economic implications of this new regimen will be substantial – even two cycles of Blincyto will at a minimum double the cost of the consolidation regimen. GlobalData estimates the US cost per Blincyto cycle to be around $66,000, which based on the proposed regimen could add an additional $130,000–250,000 for each patient treated in the US. This could add more than $100m in annual US sales for Blincyto, whose US sales reached $278m last year.
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