Biotechnology company Amgen has announced that their immunotherapy drug Blincyto® (blinatumomab) appears promising in the treatment of adults with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The company announced findings from a Phase 2 trial in a recent press release.
Acute lymphoblastic leukemia is a fast-growing cancer of the white blood cells. Relapsed/refractory ALL in adults has a dismal prognosis, with only 35–40 percent of patients reaching a remission and a median overall survival of 4–6 months. Relapsed ALL is currently managed with stem cell transplantation and chemotherapy. Up to 40% of adults with ALL have a chromosomal abnormality known as Philadelphia chromosome positive.
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct. BLINCYTO binds specifically to CD19, a protein expressed on the surface of B-cell lymphomas and leukemias, as well as CD3 on the surface of T cells. By bringing the two molecules together, the BiTE technology redirects the T cells to lyse, or kill, the cancer cells.
A Phase II trial has been evaluating Blincyto for effectiveness and safety in the treatment of patients with relapsed or refractory Ph+ ALL. The study included several cycles of Blincyto and a safety follow-up visit 30 days after patients completed treatment. The researchers continued to follow up with the patients every three months for up to 18 months to measure how long response to treatment lasted.
The results have been promising for Blincyto, as a significant number of patients’ disease has gone into remission. In addition, patients haven’t experienced any unexpected side effects.
“These top-line results are encouraging and support [Blincyto] as a potential treatment option for patients with relapsed or refractory Philadelphia chromosome-positive B-cell precursor ALL,” said According to Sean E. Harper, MD, executive vice president of Research and Development at Amgen. He added that they were hopeful that Blincyto would continue to produce good outcomes in patients with ALL.
Reference: Amgen Announces Positive BLINCYTO® (blinatumomab) Phase 2 Study Results In Patients With Relapsed/Refractory Philadelphia Chromosome-Positive B-Cell Precursor Acute Lymphoblastic Leukemia [press release]. Amgen website. Available at: https://www.amgen.com/media/media_pr_detail.jsp?year=2015&releaseID=2068505. Accessed July 20, 2015.