The most common form of leukemia in Western countries is chronic lymphocytic leukemia (CLL). The disease accounts for almost thirty percent of known leukemia cases. Approximately 30,000 Europeans were diagnosed as having CLL in 2020.
According to a recent article in Healio, CLL starts in cells in the bone marrow that become lymphocytes (white blood cells) prior to entering the bloodstream. As leukemia proliferates in the bone marrow, the body loses its infection-fighting ability. Leukemia may then spread to other areas in the body such as the liver, spleen, and lymph nodes.
About the BTK Pathway
The BTK pathway sends signals to malignant B cells. It is associated with the onset of CLL. BTK inhibitors (BTKi) block the B-cell receptor cascade by its binding to the BTK enzyme, thus preventing the survival of normal and malignant B cells.
Small lymphocytic lymphoma is similar to CLL, but its cancer cells are found primarily in lymph nodes.
Marginal zone lymphoma (MZL) begins in the peripheral areas of lymph tissues. MZL represents about five to fifteen percent of the Western world’s cases.
About BRUKINSA® (Zanubrutinib)
According to the results of the Phase III ALPINE study, zanubrutinib was shown to be superior when compared to ibrutinib, which has been the standard of care for CLL patients.
Zanubrutinib blocks one hundred percent of BTK in blood cells and over ninety-four percent of BTK in lymph nodes when taken at 320 mg daily.
Zanubrutinib is being developed to be used as monotherapy or combined with other therapy to treat B-cell malignancies. The U.S. FDA has approved the drug to treat mantle cell lymphoma patients who have received one or more previous therapies.
ALPINE trial results showed zanubrutinib to have a significant overall response rate (ORR) in patients who had either refractory (not responding to treatment) or relapsed CLL when the drug was compared with ibrutinib. Zanubrutinib showed a superior twelve-month progression-free survival and overall survival rate when compared to ibrutinib. The rate of atrial fibrillation (flutters) was lower with zanubrutinib versus ibrutinib.
The primary endpoint of 78.3% ORR with zanubrutinib was met compared to 62.5% with ibrutinib. The zanubrutinib group reported grade 3 or higher adverse events but serious events were less common than in the ibrutinib group.
There were eight treatment-related deaths in the zanubrutinib group and twelve deaths in the ibrutinib group.
Scientists at BeiGene discovered zanubrutinib, a small molecule inhibitor of BTK, that is currently undergoing analysis as a monotherapy to treat several B-cell malignancies. Zanubrutinib is also being combined with other therapies in the same major clinical program to treat B-cell malignancies.
Zanubrutinib is part of a clinical program that includes over 3,900 subjects in thirty-five trials in twenty-eight markets.
In addition, zanubrutinib has over twenty approvals across forty countries plus forty regulatory submissions worldwide.
BeiGene Oncology
The company has a growing research and development team of almost 2,900 associates conducting one hundred clinical trials in over forty-five regions and countries.
