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Amgen’s Blinatumomab nearly doubles survival time in B-Cell ALL

PBR Staff Writer Published 02 March 2017

A phase 3 study assessing Amgen’s Blincyto (blinatumomab) significantly improved overall survival (OS) in patients with B-Cell precursor acute lymphoblastic leukemia compared To chemotherapy.

The study evaluated the efficacy of Blincyto versus standard of care (SOC) chemotherapy in high-risk adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL),

The median overall survival was 7.7 months for patients receiving blinatumomab vs 4.0 months for those in the chemotherapy group.

In addition, the assessment of key secondary endpoints demonstrated that remission rates were higher for Blincyto against SOC.

Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct. It is claimed to be the first bispecific antibody construct from Amgen's BiTE platform that enables the body's immune system target cancer cells.

Currently, BiTE antibody constructs are being studied for their potential to treat a wide variety of cancers.

The phase 3 Tower study is a randomized and open-label study designed to assess the efficacy of Blincyto against SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL.

Patients have been randomized in a 2:1 ratio to receive Blincyto (n=271) or treatment with investigator choice of one of four protocol-defined SOC chemotherapy regimens (n=134).

Amgen research and development executive vice president Dr Sean Harper said: "As the first study of an immunotherapy to demonstrate overall survival benefit in adult patients with Ph- relapsed or refractory B-cell precursor ALL, Tower represents an important advance in the understanding of this aggressive, ultra-orphan disease.”

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.