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Amgen’s BLINCYTO Shows Significant Survival Benefit in Pediatric B-ALL Patients
THOUSAND OAKS, Calif., Dec. 7, 2024 /PRNewswire/ — Amgen (NASDAQ:) has released new findings indicating that the combination of BLINCYTO® (blinatumomab) with chemotherapy for pediatric patients diagnosed with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) significantly enhances disease-free survival (DFS). This data emerged from a Phase 3 study, AALL1731, conducted by the Children’s Oncology Group and was published in the New England Journal of Medicine. It is scheduled to be presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego on December 8, at 2 p.m. PT.
Dr. Jay Bradner, Amgen’s executive vice president of Research and Development and chief scientific officer, emphasized the transformative role of BLINCYTO in B-ALL treatment. “Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients,” he stated, acknowledging the collaborative efforts of the Children’s Oncology Group and everyone involved in the research.
The interim analysis of the study showed that the addition of BLINCYTO led to a 96% 3-year DFS for patients receiving the combination therapy, compared to 87.9% for those undergoing chemotherapy alone. This results in a notable 61% reduction in the risk of disease relapse, secondary malignancies, or remission deaths among patients treated with BLINCYTO.
Dr. Sumit Gupta, co-chair of the study and an oncologist at The Hospital for Sick Children (SickKids), called the results practice-changing, asserting that they establish blinatumomab as the standard of care for children with B-ALL. He noted the study’s significant contribution to improving outcomes in this patient population.
Results indicated that the use of BLINCYTO in standard risk patients achieved survival rates comparable to those of traditionally more favorable risk pediatric groups. For SR-Average patients, the DFS was 97.5% versus 90.2% with chemotherapy alone, while in SR-High patients, it was 94.1%, compared to 84.8% for chemotherapy only.
“Relapsed ALL remains a significant challenge in pediatric cancer, with nearly half of the relapses occurring within standard-risk groups,” noted Dr. Rachel E. Rau, co-chair of the study and pediatric hematologist-oncologist at Seattle Children’s Hospital. The results strongly support BLINCYTO’s integration into treatment plans to reduce relapse rates.
The safety profile of BLINCYTO aligns with previous findings, revealing low incidences of cytokine release syndrome (CRS) and seizures, albeit with a slightly elevated risk for infections in the BLINCYTO cohort.
This study represents a landmark endorsement of BLINCYTO for the consolidation phase in young patients with Philadelphia chromosome-negative B-ALL, paving the way for enhanced therapeutic strategies that transcend age and disease status.
The NCI’s Cancer Therapy Evaluation Program (CTEP) sponsored the trial and will continue to engage with the U.S. Food and Drug Administration regarding the emerging data.
About the Children’s Oncology Group
The Children’s Oncology Group (childrensoncologygroup.org) is the largest global organization focused on childhood and adolescent cancer research. It integrates over 10,000 experts from more than 200 institutions committed to improving pediatric cancer treatments, significantly boosting survival rates from once nearly incurable to an 86% combined five-year survival rate.
About AALL1731 (NCT03914625)
AALL1731 was structured as a randomized Phase 3 trial to evaluate the impact of adding two cycles of BLINCYTO to chemotherapy in children with newly diagnosed NCI SR B-ALL. With 4,264 patients enrolled, the first interim analysis marked the success of the study in meeting its primary endpoint.
About Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL) is a rapidly progressing blood cancer originating in the bone marrow, with potential to metastasize to other body organs. In the U.S., approximately 6,550 new cases are forecasted in 2024, primarily affecting children, with B-ALL being the most prevalent subtype.
About BLINCYTO® (blinatumomab)
BLINCYTO is recognized as the first Bispecific T-cell Engager (BiTE®) therapy, specifically developed to rally the immune system in targeting CD19-positive malignancies. Approved by the U.S. FDA, BLINCYTO is indicated for several patient populations affected by B-ALL, fostering enhanced outcomes among those battling this aggressive cancer.
Safety Information
BLINCYTO can cause serious side effects, including CRS and neurological toxicities. Patients and healthcare professionals must be vigilant for these adverse reactions and respond accordingly to ensure safe treatment protocols.
For ongoing updates and further information, please visit Amgen’s website and associated channels.
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