Amgen announces positive results from two Phase 3 BLINCYTO® (blinatumomab) studies In pediatric patients with relapsed acute lymphoblastic leukemia

AmgenAmgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met. The study evaluated the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia (ALL) at first relapse. Enrollment was terminated early due to encouraging efficacy in the BLINCYTO arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC). Follow up will continue as prescribed per protocol.

In addition, a randomized, Phase 3 trial (AALL1331) conducted by the Children's Oncology Group (COG) using BLINCYTO in pediatric B-cell ALL patients at first relapse has closed to accrual for the high-risk and intermediate risk-arm based on the recommendation of the COG DMC. The DMC closure decision was based on a strong trend towards improved disease-free survival and improved overall survival, markedly lower toxicity, and better minimal residual disease (MRD) clearance for BLINCYTO compared to chemotherapy. The COG DMC recommended that the AALL1331 low-risk group continue to enroll and randomize patients until enrollment goals are reached. AALL1331 is sponsored by the Cancer Therapy Evaulation Program of the National Cancer Institute (NCI), part of the National Institutes of Health, and is conducted by the NCI-funded COG. Amgen provided BLINCYTO for AALL1331 under a Collaborative Research and Development Agreement between the NCI and Amgen.

"Considered together, the results of these studies are remarkable. Children and adolescents who relapse with acute lymphoblastic leukemia face a poor prognosis and there remains a need for additional treatment options, particularly for those that are identified as high-risk. These data have the potential to be practice-changing and may provide a treatment approach to prevent further relapse that is superior to chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing these data with regulatory authorities."

The BLINCYTO adverse events observed in the Phase 3 20120215 and the COG AALL1331 studies were consistent with the known safety profile of BLINCYTO. These interim data will be submitted to a future medical conference and for publication.

About the 20120215 Study

Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial to evaluate event-free survival after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first relapsed B-cell ALL. Key secondary endpoints included incidence of overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA. The study is being conducted in Australia and various countries in EU and Latin America. Click here to read about the trial on ClinicalTrials.gov.

About the COG AALL1331 Study

The COG AALL1331 study is a risk-stratified, randomized, Phase 3 trial of blinatumomab in first relapse of pediatric B-ALL to evaluate disease-free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapsed B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab. It also compares the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab. Key secondary endpoints include overall survival of HR, IR, and LR relapsed B-ALL patients. This is a global study that is being conducted in Australia, Canada, New Zealand and United States. Click here to read about the trial on ClinicalTrials.gov.

About BLINCYTO® (blinatumomab)

BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:

  • relapsed or refractory B-cell precursor ALL in adults and children.
  • B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
  • This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In the EU, BLINCYTO is indicated as monotherapy for the treatment of:

  • adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
  • adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
  • paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation

About BiTE® Technology

Bispecific T cell engager (BiTE®) technology is a targeted immuno-oncology platform designed to engage patients' own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.

Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.

About Amgen Oncology

Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life - not just their cancer journey - so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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