During the upcoming 21st Congress of the European Hematology Association (EHA), the premier hematology congress in Europe being held June 9-12, 2016, in Copenhagen, Denmark, Amgen will highlights data from the TOWER Study [1] which demonstrates that blinatumomab (Blincyto®; previously known as AMG 103) demonstrates improved overall survival versus standard of care (SOC) chemotherapy in patients with B-Cell precursor acute lymphoblastic leukemia (ALL).

At the same time, the results of the TOWER study will be presented on June 10 at the Presidential Symposium as a “Best EHA-Copenhagen_2016Abstract.” [2]

The phase III randomized TOWER study was designed to evaluate blinatumomab vs. investigator choice of chemotherapy in adult subjects with relapsed/refractory (R/R) B-precursor ALL.  Patients were randomized in a 2:1 ratio to receive blinatumomab or treatment with an investigator choice of 1 of 4 protocol defined SOC chemotherapy regimens.* The primary endpoint was Overall Survival (OS).

MabPlex
Lonza
ADC Bio
 

The key blinatumomab data to be presented during the EHA congress is expected to reinforces Amgen’s commitment to serve patients with hematologic malignancies through the development of innovative and novel products.

“We are excited that the data from the TOWER study, which is the first randomized study of an immunotherapy to demonstrate overall survival benefit in adult patients with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, will be featured at the Presidential Symposium this year at EHA,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

“This recognition along with other key data being presented validates our ongoing commitment to developing innovative therapies that have the potential to tackle unmet needs in complex-to-treat patient populations,” he continued.

CD-19
Blinatumomab is the first drug in a new class of agents targeting CD19, a protein expressed on the surface of B-cell-derived acute lymphoblastic leukemia’s (ALLs) and non-Hodgkin’s lymphomas.

As a bispecific CD19-directed CD3 T cell engager (BiTE®), the novel antibody construct blinatumomab binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. In doing so, BiTE, antibodies are designed to function as a bridge between cancer cells and cytotoxic T lymphocytes (CTLs), aiming to engage two different targets simultaneously: the endogenous cytotoxic potential or CTLs to target the lysis of malignant cells. [3]

Approval
The drug was granted conditional marketing authorization by the European Commission (EC) in November 2015.  It became the first bispecific T cell engager antibody construct approved in the European Union for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.

Blinatumomab was also granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration (FDA), and is now approved in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.


Note: *Standard of Care (SOC) Chemotherapy:

  • FLAG ± anthracycline based regimen (including Idarubicin 10 mg/m2 days 1, 3; fludarabine 30 mg/m2 days 1-5; cytarabine 2g/m2 days 1-5)
  • HiDAC based regimen that utilize doses of cytarabine arabinoside at least 1 g/m2 or greater per day ± anthracycline and/or in combination with other drugs such as native E.coli asparaginase, PEG-asparaginase, vinca alkaloids, steroids, etoposide or alkylating agents
  • High-dose methotrexate based regimen (such as 500 mg/m2 – 3 g/m2 HDMTX (infusion time up to 24 hours) in combination with other drugs such as native E.coli asparaginase, PEG-asparaginase, vinca alkaloids, steroids, etoposide or alkylating agents
  • Clofarabine or clofarabine based regimens