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European Commission Approves BLINCYTO for Acute Lymphoblastic Leukemia

Amgen (NASDAQ: AMGN) has scored a significant milestone with the approval of its monoclonal antibody, BLINCYTO® (Blinatumomab), by the European Commission. This decision marks an essential advancement in the treatment of adults diagnosed with Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) during the consolidation phase.

The approval comes on the heels of findings from the E1910 trial, a pivotal Phase 3 clinical study orchestrated by the ECOG-ACRIN Cancer Research Group. This research examined the potential benefits of adding BLINCYTO to a multi-phase consolidation chemotherapy regimen for patients who had been newly diagnosed. The results were compelling: patients receiving BLINCYTO alongside chemotherapy displayed a marked improvement in overall survival rates compared to those receiving chemotherapy alone. Specifically, at a median follow-up of 4.5 years, the five-year overall survival (OS) rate was found to be 82.4% for the BLINCYTO and chemotherapy group versus 62.5% for the chemotherapy-only cohort.

Jean-Charles Soria, Senior Vice President of Global Oncology Development at Amgen, commented on the significance of this approval, indicating that it allows for earlier access to BLINCYTO in the treatment journey of patients, potentially enhancing their outcomes. He stated, "This approval represents a substantial step forward, offering patients the opportunity to receive BLINCYTO earlier in their treatment sequence."

The E1910 study aimed to deepen remission for patients, targeting those with a minimal residual disease (MRD) of at least 0.1%. Robin Foà, an emeritus professor of Hematology at La Sapienza University in Rome, pointed out that although advancements in treatment have been made, many patients still face a high risk of relapse. He reiterated that the results underscore BLINCYTO's potential to significantly influence first-line consolidation therapy, even for patients who are MRD-negative.

The study was conducted independently of industry affiliations and was publicly funded by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH). Amgen supported the study by providing BLINCYTO as part of a research and development cooperative agreement with the NCI.

Understanding Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is characterized by the rapid proliferation of immature white blood cells in the bone marrow, occasionally infiltrating other parts of the body, such as lymph nodes, spleen, and central nervous system. In Europe, the estimated incidence of ALL stands at 1.28 per 100,000 people. The most prevalent subtype is B-ALL, which originates from precursor B-cells that typically mature into B-cell lymphocytes. B-ALL accounts for roughly 75% of ALL cases in adults.

A Closer Look at BLINCYTO® (Blinatumomab)

BLINCYTO is heralded as the world’s first bispecific T-cell engager (BiTE) immuno-oncology therapy, specifically targeting CD19 surface antigens on B-cells. BiTE molecules function by bridging T-cells with malignant cells, enhancing the immune system's capacity to recognize and eliminate cancerous cells. As T-cells draw near to the cancer cells, they can inflict cytotoxic effects, ultimately leading to cancer cell death (apoptosis). The BiTE platform is currently under investigation for its efficacy across a range of other cancers.

In the European Union (EU), BLINCYTO is indicated for several patient populations:

• - Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL.
• - Adults in the first or second complete remission with minimal residual disease.
• - Pediatric patients aged one month or older, refractory after at least two previous therapies or experiencing a relapse post-transplant.
• - High-risk pediatric patients in their first relapse within a consolidation framework.

The approval of BLINCYTO in the USA was granted through expedited pathways, emphasizing its considerable therapeutic potential in treating patients during consolidation phases across various diagnostics.

The Future of BiTE Technology

The BiTE technology platform stands as a promising area of exploration, poised to unlock innovative treatments aimed at targeting various tumor types based on specific antigens. Amgen is committed to leveraging this technology to intensify the effectiveness of T-cell therapies, ensuring that patients have access to potentially life-saving treatments when required.

As Amgen continues to expand its pipeline of therapies targeting oncology and other severe diseases, the company remains at the forefront of innovation, committed to enhancing the quality of life for patients worldwide. For more information on Amgen and its initiatives, visit Amgen.com and follow them on social media platforms.