Three-drug combination therapy effective in patients with high-risk CLL, trial shows

Researchers have found in a phase 2 clinical trial led by Dana-Farber Cancer Institute that three-drug combination that sent chronic lymphocytic leukemia (CLL) into deep remissions in a broad group of patients in a clinical trial is highly effective in patients with high-risk forms of the disease.

The initial cohort of the trial, which included patients with any subtype of CLL, found that a regimen of acalabrutinib, venetoclax, and obinutuzumab produced deep remissions in 89% of participants. The new cohort, which exclusively included patients with high-risk CLL, found a similar deep-remission rate of 83%.

The study's lead author, Christine Ryan, MD, of Dana-Farber, will present the findings at the American Society of Hematology (ASH) Annual Meeting.

The trial, conducted at Dana-Farber, Beth Israel Deaconess Medical Center, Stamford (Conn.) Hospital, and Lifespan Health System, in Rhode Island, involves 68 patients with previously untreated CLL, 41 of whom have a mutation and/or deletion in the TP53 gene in their tumor cells – an abnormality associated with an aggressive form of the disease. Patients are treated with acalabrutinib (a targeted drug), obinutuzumab (an antibody therapy), and venetoclax (a targeted agent) on a specified schedule that can continue for up to 16 cycles.