Paolo Ghia, MD, PhD, Professor at the Università Vita-Salute San Raffaele, Milan, Italy, discusses the updated, long-term data from the phase 2 CAPTIVATE study. This study evaluated ibrutinib plus venetoclax as a first-line treatment for chronic lymphocytic leukemia (CLL); data from this trial was recently presented at the American Society of Hematology Meeting & Exposition (ASH 2021).
Paolo Ghia, MD, PhD, Professor at the Università Vita-Salute San Raffaele, Milan, Italy, discusses the updated, long-term data from the phase 2 CAPTIVATE study. This study evaluated ibrutinib plus venetoclax as a first-line treatment for chronic lymphocytic leukemia (CLL); data from this trial was recently presented at the American Society of Hematology Meeting & Exposition (ASH 2021).
CLL is a rare blood cancer resulting in a build-up of lymphocytes in bone marrow, lymph nodes, and blood. The disease is treatable, but relapse is very common.
As Dr. Ghia explains, the CAPTIVATE study is a multicenter, double-blind, phase 2 study with previously untreated CLL patients under the age of 70 years. Patients were given 3 cycles of ibrutinib and an additional 12 cycles of ibrutinib plus venetoclax. Patients who had confirmed rates of undetectable minimal residual disease (uMRD) were then randomized to receive ibrutinib or placebo. Patients who did not meet the definition of undetectable MRD were randomized to receive ibrutinib alone or continued combination therapy. The endpoints presented at ASH 2021 included: 2-year disease-free survival rate (defined as survival without progression or MRD relapse post-randomization) in patients with confirmed uMRD randomized to placebo vs ibrutinib, rates of uMRD (by 8-color flow cytometry), investigator-assessed best response per iwCLL, investigator-assessed PFS, and adverse events (AEs).
Dr. Ghia goes on to discuss the long-term data. No new MRD relapses, progressions, or deaths in patients with confirmed uMRD occured since data from the CAPTIVATE trial were presented last year. The 2-year disease free survival (DFS) rate in the MRD-guided placebo arm remained high at 95% while 3-year progressive free survival (PFS) rates were greater than 95% across all randomized treatment arms. The results in patients with confirmed uMRD support the potential for treatment-free remission with fixed-duration treatment, including in patients with high-risk features. High rates of uMRD were achieved; the safety profile of ibrutinib plus venetoclax was consistent with the known safety profiles of each agent. The most frequent grade 3/4 AEs were neutropenia, hypertension, thrombocytopenia, and diarrhea.
For more information about CLL and other rare cancers, visit checkrare.com/diseases/cancers/