Blinatumomab Approved in Consolidation Phase for CD-19+ Ph-Negative Precursor B-ALL, “Redefines Standard of Care”

FDA has approved blinatumomab, a bispecific T-cell engager, for use in the frontline setting to treat patients as young as 1 month old who have C19-positive (CD19+) Philadelphia chromosome-negative precursor acute lymphoblastic leukemia (B-ALL), according to a statement from Amgen, which markets the drug as Blincyto.¹

The approval allows blinatumomab to be used as part of a postinduction consolidation regimen, which is designed to deepen remission and extend a durable response. Patients who received blinatumomab during their consolidation phase demonstrated overall survival (OS) of 84.8% at 3 years, compared with 69% for those who received chemotherapy alone, for a hazard ratio (HR) of 0.42 (95% CI; 0.24-0.75; P = .003). Each arm had 112 patients.^1,2

At a median follow-up of 4.5 years, the 5-year OS was 82.4% in the blinatumomab plus chemotherapy arm vs 62.5% in the chemotherapy arm.

Selina Luger, MD | Image credit: Penn Medicine

Selina M. Luger, MD, professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee and an investigator on the study, said the approval “redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone."

"B-ALL is an aggressive blood cancer with enduring high unmet need. [Blinatumomab] has helped thousands of patients with B-ALL over the last 10 years. Today's approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager therapy," Jay Bradner, MD, executive vice president, Research and Development, and chief scientific officer at Amgen, said in the statement.¹

Blinatumomab is approved in several indications in the US and in Europe. Last year, FDA granted full approval for blinatumomab to treat patients with CD19-positive B-ALL who are in their first or second complete remission, with MRD greater than or equal to 0.1%.³ This new group of patients covered by today’s approval can be treated regardless of MRD status, according to the statement.¹

"The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy," said E. Anders Kolb, MD, president and chief executive officer of The Leukemia & Lymphoma Society. "B-ALL is the most common type of ALL and having another effective option available earlier in a patient's treatment journey is critical for clinicians who are working to give these patients more time with their loved ones."

The study that led to today’s approval was designed and conducted independently from industry, Amgen said in its statement. 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 made blinatumomab available through an NCI Cooperative Research and Development Agreement.

A rare, aggressive cancer of the bone marrow, ALL can spread to the lymph nodes, liver, spleen, and central nervous system. It affected 6540 new patients in the US in 2023. B-ALL originates in white cells that would normally grow into bone marrow and is the most common type of ALL in adults. Blinatumomab works by targeting C19 surface antigens on B cells and engaging nearby T cells, which then hit cancer cells with toxins to kill them.

References

1. FDA approves Blincyto (blinatumomab) in CD19-positive Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase. Amgen. June 14, 2024. Accessed June 14, 2024. https://www.amgen.com/newsroom/press-releases/2024/06/fda-approves-blincyto-blinatumomab-in-cd19positive-philadelphia-chromosomenegative-bcell-precursor-acute-lymphoblastic-leukemia-ball-in-the-consolidation-phase
2. FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. FDA. June 14, 2024. Accessed June 14, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell
3. FDA grants full approval for Blincyto (blinatumomab) to treat minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. News release. Amgen. June 21, 2023. Accessed June 21, 2023. https://bit.ly/3XjCsbG