A combination of two drugs keeps patients with chronic lymphocytic leukemia (CLL) disease-free and alive longer than the current standard of care, according to a phase 3 clinical trial of more than 500 participants conducted at Stanford Medicine and multiple other institutions.
Currently, CLL patients who are fit enough to tolerate aggressive treatment are treated intravenously with a combination of three drugs: rituximab, which specifically targets the B cells that run amok in CLL, and fludarabine and cyclophosphamide, which kill both healthy and diseased cells and can cause significant side effects including severe blood complications and life-threatening infections that are difficult for many patients to tolerate.
The new drug combination pairs rituximab with another drug, ibrutinib, which also specifically targets B cells.
The researchers found that 89.4% of participants who received the experimental drug combination had still not had leukemia progression about three years later compared with 72.9% of those who received the traditional chemotherapy combination. Overall survival between the two groups also improved; 98.8% of the participants randomly assigned to receive the new drug combination were alive after three years compared with 91.5% of those who had received the traditional treatment.
Although the incidence of serious treatment-related adverse events was similar between the two groups, infectious complications occurred more frequently in the group receiving the traditional treatment.
“This is one of those situations we don’t often have in oncology,” said Tait Shanafelt, MD, professor of medicine at Stanford. “The new treatment is both more effective and better tolerated. This represents a paradigm shift in how these patients should be treated. We can now relegate chemotherapy to a fallback plan rather than a first-line course of action.”
Source: EurekAlert!, July 31, 2019