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TOWER - A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)
Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02013167?term=blinatumomab&rank=5

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Blincyto (Blinatumomab)Oncology HematologicAcute Lymphocytic Leukemia (ALL)Anti-CD19/anti-CD3 bispecific mAbCD19/CD3 antigen

Mechanism of action: Blincyto (Blinatumomab) is a recombinant, single-chain, anti-CD19/anti-CD3 bispecific monoclonal antibody with potential immunostimulating and antineoplastic activities. Blinatumomab posesses two antigen-recognition sites, one for the CD3 complex, a group of T cell surface glycoproteins that complex with the T cell receptor (TCR), and one for CD19, a tumor-associated antigen (TAA) overexpressed on the surface of B cells. This bispecific monoclonal antibody brings CD19-expressing tumor B-cells and cytotoxic T lymphocytes (CTLs) and helper T lymphocytes (HTLs) together, which may result in the CTL- and HTL-mediated cell death of CD19-expressing B-lymphocytes.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-05-01 - 2016-06-30

Results:

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Phase 3 Study of BLINCYTO® (Blinatumomab) Met Primary Endpoint Of Overall Survival In Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
Study Stopped Early for Efficacy
THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO® (blinatumomab) versus standard of care (SOC) in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy.

The BLINCYTO adverse events observed in the TOWER study were consistent with the known safety profile of BLINCYTO. Secondary endpoints are currently being evaluated. These interim data will be submitted to a future medical conference and for publication.

"The FDA's breakthrough therapy designation and accelerated approval of BLINCYTO underscore the dire prognosis for these patients. This is the first study to demonstrate an overall survival benefit for these patients with an immunotherapy, and this is a tremendously rare achievement in relapsed and refractory ALL," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We will work with regulatory authorities towards a full approval for BLINCYTO in this population."
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Source: press release, 2/04/16. http://wwwext.amgen.com/media/news-releases/2016/02/phase-3-study-of-bli...

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