#USA #Amgen #Thousand Oaks #BLINCYTO #Acute Lymphoblastic Leukemia

European Commission Approves BLINCYTO® for Adult B-ALL

In a recent announcement, Amgen (NASDAQ:AMGN) confirmed that the European Commission has officially approved the use of BLINCYTO® (blinatumomab) as a monotherapy within consolidation therapy for adults diagnosed with CD19-positive acute lymphoblastic leukemia (B-ALL), which is negative for the Philadelphia chromosome. This marks a notable advancement in the fight against this challenging form of leukemia, which necessitates effective and innovative treatment options.

The Significance of Approval

Jean-Charles Soria, Senior Vice President of Global Development in Oncology at Amgen, states, "This approval signifies a remarkable progress in providing patients access to BLINCYTO at an early point in their treatment, with the potential to improve outcomes." The clinical study that led to this approval, the E1910 trial conducted by the ECOG-ACRIN Cancer Research Group, highlighted the need for depths of remission to ensure long-term survival in patients with newly diagnosed B-ALL. The findings from this Phase 3 trial revealed that patients receiving BLINCYTO along with multi-phase consolidation chemotherapy had significantly improved overall survival rates compared to those on chemotherapy alone.

Study Results

The study observed a 5-year overall survival rate of 82.4% for patients treated with both BLINCYTO and chemotherapy, versus 62.5% for the chemotherapy-only group. These results underscore the potential role of BLINCYTO as a game-changer in first-line consolidation treatment, especially for patients with minimal residual disease.

Dr. Robin Foà, a notable hematology professor from Sapienza University in Rome, emphasizes that "despite some strides in treatment, many patients with CD19-positive B-ALL remain at high risk for relapse." He points out that the E1910 trial results confirm BLINCYTO’s potential to enhance first-line consolidation therapy, offering a crucial new option for deeper remissions and improved long-term survival for affected patients.

Understanding Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a rapidly progressing type of blood cancer stemming from the bone marrow that can also spread to other bodily areas, such as lymph nodes, the liver, and the central nervous system. In Europe, the incidence of ALL is estimated at approximately 1.28 individuals per 100,000. Of the various subtypes of ALL, B-ALL is predominant, accounting for about 75% of cases in adults. This particular subtype originates within immature cells typically developing into B-cell lymphocytes (a type of white blood cell produced in the bone marrow).

About BLINCYTO®

BLINCYTO®, recognized as the world’s first T-cell engaging therapy using bispecific T-cell engagers (BiTE®), specifically targets surface antigens CD19 on B cells. This innovative treatment works by leveraging the body’s immune system to recognize and attack malignant cells. By drawing T-cells, capable of eliminating threats, closer to cancer cells, BLINCYTO® facilitates the delivery of toxins that lead to cancer cell death (apoptosis). Currently, BiTE® therapies are being explored for their capabilities in treating a wide array of malignancies.

In the European Union, BLINCYTO has been indicated for the following:

• - Adults with Ph-negative CD19-positive relapsed or refractory B-ALL.
• - Adults with Ph-negative CD19-positive B-ALL in first or second complete remission with detectable minimal residual disease.
• - Pediatric patients, aged one month and older, with Ph-negative CD19-positive B-ALL who are either refractory or have relapsed after at least two prior therapies.

Safety Profile and Future Prospects

The safety profile for BLINCYTO was consistent with its historical safety data during the Phase 3 E1910 trial. Additionally, the BiTE® technology presents a promising immuno-oncology platform that activates the patient's T-cells to target any tumor-specific antigen, potentially benefitting various cancer types.

Amgen continues to lead the charge in developing treatments that harness innovative biotechnological advancements, aiming to offer substantial improvements in the lives of those battling severe diseases. With accolades recognizing it as one of the most innovative companies in the world, Amgen remains committed to furthering cancer treatment as it seeks to bring new therapies into mainstream use, significantly impacting the future of oncology treatment.