Blinatumomab brings hope to acute lymphoblastic leukemia patients7 Dec 2015
New data has emerged from three Phase 2 trials support the efficacy and safety of blinatumomab in adults with acute lymphoblastic leukemia (ALL), a rare and rapidly progressing cancer of the blood and bone marrow.
Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL beyond chemotherapy.
Clinically meaningful results
In a Phase 2 confirmatory multicenter single-arm trial (BLAST), adult patients with B-cell precursor acute lymphoblastic leukemia with minimal residual disease who received blinatumomab monotherapy demonstrated clinically meaningful relapse-free survival, as measured in the key secondary endpoint.
Median relapse-free survival was 18.9 months following initiation of blinatumomab. Minimal residual disease refers to the presence of leukemia blast cells below the limits of detection available with standard assessment.
Blinatumomab’s potential to other ALL patient subpopulations
Blinatumomab's potential has also been demonstrated in a high risk subpopulation of patients with relapsed or refractory Philadelphia chromosome-positive (Ph) B-precursor ALL and confirm blinatumomab's efficacy in a subset of patients with relapsed or refractory Philadelphia chromosome-negative (Ph-) ALL after an allogeneic hematopoietic stem cell transplantation (alloHSCT), who typically have poor outcomes with current therapies.
Around 15-30% of adult ALL patients are Ph and these patients typically have a poor response to standard therapy, short remission duration and low survival rates.
"A key goal in the treatment of blood cancers is to prevent relapse from occurring," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The data presented are highly encouraging because they support the potential of blinatumomab in a broader spectrum of ALL patients, including those at an earlier stage of disease."Source: eCancer News