A three-drug regimen that produced remarkable remissions in chronic lymphocytic leukaemia (CLL) patients in a clinical research is extremely helpful in patients with high-risk variations of the illness, according to a new phase 2 clinical trial run by clinicians at the Dana-Farber Cancer Institute.
Acalabrutinib, venetoclax, and obinutuzumab were reported to elicit profound remissions in 89% of participants in the initial cohort of the trial, which included patients with any subtype of CLL. The second cohort discovered a same 83% deep-remission rate, although it only included individuals with high-risk CLL. Dr. Christine Ryan, the study’s principal investigator from Dana-Farber, will present the research’s findings at the ASH Annual Meeting.
68 patients with previously untreated CLL are enrolled in the trial, which is being conducted at Dana-Farber, Beth Israel Deaconess Medical Center, Stamford (Conn.) Hospital, and Lifespan Health System in Rhode Island. Of these, 41 have a mutation and/or deletion in the TP53 gene in their tumour cells, an abnormality linked to an aggressive form of the disease.
Acalabrutinib, an antibody treatment, obinutuzumab, and venetoclax are administered to patients according to a predetermined regimen that may last up to 16 cycles.
83% of the high-risk patients had undetected minimum residual disease (MRD), or no detectable CLL cells per 100,000 white blood cells, in their bone marrow after a median follow-up of 35 months.
Moreover, 45% of patients experienced the most profoundly discernible response to the therapy: total remission and undetectable MRD in the bone marrow.
Researchers discovered that the therapy was generally well-tolerated, with minimal incidence of infections and cardiovascular issues.
Ninety-three percent of the study participants were still alive and their diseases had not progressed after almost three years of follow-up. The study has helped to establish a major phase III trial of the regimen for CLL patients without a high-risk condition, which may result in FDA approval of the regimen.
“Our data provide foundational support for using this triplet therapy in patients with high-risk CLL patients,” says study senior author and principal investigator Matthew Davids, MD, MMSC, of Dana-Farber.