Blincyto approved in Europe for newly diagnosed adults with B-ALL
Consolidation therapy regimen can now be used to treat blood cancer type
The European Commission has approved Blincyto (blinatumomab) as part of a consolidation therapy regimen to reduce the risk of relapse in adults newly diagnosed with B-cell precursor acute lymphoblastic leukemia, or B-ALL, a type of blood cancer.
Eligible patients in the European Union will have tumor cells positive for the CD19 protein and negative for a genetic abnormality called the Philadelphia chromosome, according to the decision by the commission, the EU’s main executive body.
Blincyto will be given as one part of a multiphase consolidation chemotherapy regimen in these patients. Consolidation regimens are done after initial chemotherapy has induced disease remission — which is known as induction therapy — to kill off any remaining cancer cells that could cause a relapse.
The antibody therapy from Amgen was already approved in the EU for other indications in B-ALL. Among its authorized uses was as a treatment for certain groups of children and adults with disease that’s relapsed, or come back after treatment, for those whose disease is refractory — meaning it did not respond to treatment — or for patients who are in remission but at a high risk of relapse.
Now, it can also be used for adults who are in remission after induction therapy, even if they aren’t considered to be at a high relapse risk, according to Amgen.
“This approval represents a significant advancement, offering patients the opportunity to receive Blincyto earlier in their treatment pathway, with the potential to improve outcomes,” Jean-Charles Soria, MD, PhD, senior vice president of global oncology development at Amgen, said in a company press release. “The [new] data that served as the basis of this approval adds to the growing body of evidence of the meaningful survival impact of Blincyto.”
B-ALL is most common subtype of fast-growing type of blood cancer
Acute lymphoblastic leukemia is a fast-growing type of blood cancer that develops in the bone marrow and affects immature white blood cells. B-ALL, the most common subtype of the disease, affects the cells that will eventually become B-cells, a type of immune cell.
Blincyto is a bispecific antibody, meaning it simultaneously targets two different proteins. Its ultimate goal is to help immune T-cells — which have innate cancer-fighting abilities — to recognize and launch an immune attack against cancerous cells.
Specifically, Blincyto targets CD19, a protein found on the surface of B-cells and their precursors, as well as CD3, a protein on the surface of T-cells. By binding to both at the same time, it serves as a sort of bridge to bring the two cell types together. Once they’ve engaged with the cancer cells, the T-cells can trigger their death.
Beyond its new indication, Blincyto is approved in the EU for other uses in CD19-positive, Philadelphia chromosome-negative B-ALL.
In adults, it is cleared for patients with relapsed/refractory disease, or those who are in remission after first-line or second-line treatment, but who have minimal residual disease (MRD) of at least 0.1%. MRD refers to the small number of cancer cells that can remain after treatment and which may increase the risk of a future relapse.
For pediatric patients ages 1 month or older, Blincyto is approved for those with relapsed or refractory disease after at least two prior therapies, or who relapsed after receiving a stem cell transplant. It’s also cleared as part of consolidation therapy for first-relapsed pediatric patients with high-risk disease.
Adults with Philadelphia chromosome-positive B-ALL can use Blincyto if they’ve failed to respond to at least two tyrosine kinase inhibitors and have no alternative treatment options.
Blincyto has similar approvals in the U.S., including for certain patients ages 1 month or older, with relapsed/refractory disease, in first or second complete remission with MRD at least 0.1%, or during the consolidation phase of multiphase therapy.
Blincyto EU label expansion based on data from Phase 3 E1910 trial
The basis for this European label expansion came from a Phase 3 E1910 clinical trial (NCT02003222) sponsored by the National Cancer Institute in the U.S. That study involved more than 480 adults, ages 30-70, with Philadelphia chromosome-negative B-ALL.
Participants who were in remission and MRD-negative after initial chemotherapy treatments were randomly assigned to receive a consolidation chemotherapy regimen either with or without Blincyto added.
The results showed that Blincyto, when added to a multiphase consolidation regimen, led to significantly longer overall survival relative to chemotherapy alone.
Over a median of 4.5 years, the five-year overall survival was 82.4% with Blincyto plus chemotherapy, compared to 62.5% with chemotherapy alone, according to Amgen.
The E1910 study results highlight that Blincyto has the potential to advance frontline consolidation treatment, … offering a crucial new option to achieve deeper remissions and improve long-term survival.
“While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse,” said Robin Foà , MD, emeritus professor of hematology at Sapienza University of Rome.
“The E1910 study results highlight that Blincyto has the potential to advance frontline consolidation treatment, including [for] patients who are minimal residual disease (MRD)-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival,” Foà said.
Blincyto’s safety profile in this patient population was similar to the therapy’s known profile in other indications, Amgen said.
About the Author
