Amgen (AMGN) Announces BLINCYTO Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation Chemotherapy In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

March 2, 2021 4:00 PM EST

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Amgen (NASDAQ: AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with BLINCYTO were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with BLINCYTO, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the BLINCYTO group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

"Acute lymphoblastic leukemia is the most common type of cancer in children. Unfortunately, approximately 15% of children with high-risk B-ALL relapse after frontline chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "There remains an urgent need for novel treatment options for these patients, and the study results support BLINCYTO as a new standard of care consolidation therapy for patients with this aggressive disease."

In the BLINCYTO group versus the chemotherapy group, the incidence of serious adverse events (AEs) was 24.1% vs. 43.1%, respectively, and the incidence of adverse events of grade 3 or higher was 57.4% vs. 82.4% respectively. No fatal adverse events were reported. The most common adverse events (AEs) in the BLINCYTO treatment arm were pyrexia (81.5%), nausea (40.7%), headache (35.2%), stomatitis (35.2%) and vomiting (29.6%).

"I am thrilled the study results demonstrated that BLINCYTO was more effective and associated with fewer and less severe toxicities compared to intensive chemotherapy," said study investigator, Franco Locatelli, M.D., PhD, Sapienza, University of Rome, Department of Pediatric Hematology and Oncology, Bambino Gesù Children's Hospital, Rome. "Chemotherapy has been used as primary consolidation treatment for ALL patients before receiving a stem cell transplant, despite this approach being only partially effective and associated with relevant toxicity. BLINCYTO has now been shown to be a more effective and safer consolidation therapy option for children with high-risk first-relapse B-ALL."

Results from the Children's Oncology Group (COG) Phase 3 study (AALL1331) evaluating BLINCYTO in children, adolescents, and young adults with first-relapse B-ALL have also been published today in JAMA.2 In both studies, treatment with BLINCYTO resulted in less severe toxicities and higher rates of MRD remission.

BLINCYTO, a bispecific CD19-directed CD3 T cell BiTE® (bispecific T cell engager) molecule, is the first approved molecule from Amgen's BiTE immuno-oncology platform, and the first and only therapy to receive regulatory approval globally for the treatment of MRD-positive B-cell precursor ALL.



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