Press release
BLINCYTO® (BLINATUMOMAB) ADDED TO CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN NEWLY DIAGNOSED PEDIATRIC PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL)
Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif., Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
About this update from Amgen Inc.
[{"type":"text","content":"Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96%\nTHOUSAND OAKS, Calif., Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8, at 2 p.m. PT at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.\n\"Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients,\" said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. \"These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children's Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer.\"\nBased on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone.\n\"The AALL1731 study results are truly practice-changing, further solidifying blinatumomab's role as the stan...