Dr. Wierda on the Results of the CAPTIVATE Trial in CLL and SLL

William G. Wierda, MD, PhD, professor, D. B. Lane Cancer Research Distinguished Professor, section chief of Chronic Lymphocytic Leukemia, center medical director, Department of Leukemia, Division of Cancer Medicine, and executive medical director, The University of Texas MD Anderson Cancer Center, discusses results from the CAPTIVATE trial in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The multicenter, double-blind, phase 2 CAPTIVATE study ​randomized patients with CLL or SLL who had confirmed rates of undetectable minimal residual disease (uMRD) to receive ibrutinib (Imbruvica) or placebo after 12 cycles of ibrutinib plus venetoclax (Venclexta). Patients who did not meet the definition of ​uMRD were randomized to ibrutinib ​or continued ibrutinib and venetoclax. The primary end point ​of the study was disease-free survival (DFS), Wierda says.

Results ​of the study, which were presented virtually during the 2020 ASH Annual Meeting, showed that the 1-year DFS ​rate in patients who ​had uMRD and received ibrutinib (100%; 95% CI, 100%-100%) was not significantly different from the 1-year DFS rate in patients who received placebo (95.3%; 95% CI​, 82.7​%-98.8​%; P = .1475). These findings support the role of fixed-duration targeted ​combination strategies in patients who achieve uMRD status, Wierda concludes.