FDA Approves Blinatumomab for Adult and Pediatric Patients With B-ALL

Blinatumomab (Blincyto; Amgen) received FDA approval for the treatment of adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL). The approval is based on the phase 3 E1910 (NCT02003222) clinical trial results which demonstrated that blinatumomab treatment in conjunction with multiphase consolidation chemotherapy showed superior overall survival (OS) compared with chemotherapy alone, potentially offering an alternative treatment path for patients.

The findings have significant implications for adult and pediatric patients, demonstrating superior OS when combined with multiphase consolidation chemotherapy compared with chemotherapy alone. Image Credit: © tonstock - stock.adobe.com

Acute lymphoblastic leukemia (ALL) is a fast-growing, rare blood cancer that develops in the bone marrow and is characterized by the rapid creation of immature lymphocytes, crowding out healthy cells and dysregulating normal blood cell production. B-ALL is the most common form of ALL, and it affects the healthy production and maturation of immature cells into B-cell lymphocytes, which can lead to anemia, low platelet counts, and an impaired immune system.¹

Blinatumomab is an immunotherapy agent that binds to CD19, a protein found on the surface of ALL cells, and CD3, a protein expressed on T cells, to help the immune system detect and target malignant cells. When brought near cancer cells, T cells inject toxins to help trigger cell death and prevent the progression of disease.²

The phase 3 E1910 clinical trial involved 488 patients with newly diagnosed B-ALL who were in the postinduction consolidation and were minimal residual disease (MRD) negative after induction and intensification chemotherapy. The study authors randomly assigned participants to receive either blinatumomab plus multiphase consolidation chemotherapy or chemotherapy alone to compare OS and relapse-free survival of the 2 treatment arms.³

Patients from the blinatumomab plus chemotherapy arm had a 3-year OS of 84.8% (n=112) compared with 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42, indicating a significant reduction in risk of death. Additionally, the study authors observed a 5-year OS of 82.4% in the blinatumomab arm after a median follow-up of 4.5 years.³

"In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival," study investigator Selina M. Luger, MD, professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center and chair of the ECOG-ACRIN Leukemia Committee, said in a news release. "This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone."³

The findings have significant implications for adult and pediatric patients, demonstrating superior OS when combined with multiphase consolidation chemotherapy compared with chemotherapy alone. The approval validates blinatumomab’s efficacy and helps to provide alternative treatments to encourage improved outcomes and quality of life for patients with B-ALL.

"The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy," E. Anders Kolb, MD, president and chief executive officer of The Leukemia & Lymphoma Society, said in a news release. "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."³

References

1. B cell acute lymphoblastic leukemia. The Ohio State University. Accessed June 17, 2024. https://cancer.osu.edu/for-patients-and-caregivers/learn-about-cancers-and-treatments/cancers-conditions-and-treatment/cancer-types/blood-cancers/leukemia/b-cell-acute-lymphoblastic-leukemia#:~:text=What's%20B%2Dcell%20acute%20lymphoblastic,helps%20your%20body%20fight%20infection.

2. Blinatumomab extends survival for patients with advanced ALL. National Cancer Institute. May 30, 2017. Accessed June 17, 2024. https://www.cancer.gov/news-events/cancer-currents-blog/2017/blinatumomab-leukemia

3. FDA approves blincyto® (blinatumomab) in cd19-positive philadelphia chromosome-negative b-cell precursor acute lymphoblastic leukemia (b-all) in the consolidation phase. PR Newswire. June 14, 2024. Accessed June 17, 2024. https://www.prnewswire.com/news-releases/fda-approves-blincyto-blinatumomab-in-cd19-positive-philadelphia-chromosome-negative-b-cell-precursor-acute-lymphoblastic-leukemia-b-all-in-the-consolidation-phase-302173376.html