The 5-year follow-up data of the CAPTIVATE study demonstrated that first-line ibrutinib plus venetoclax delivers deep and durable responses in patients with chronic lymphocytic leukaemia (CLL).
The combination of ibrutinib and venetoclax, an oral, once daily, chemotherapy-free regimen, has recently been approved in the EU as treatment for patients with previously untreated CLL. At the 2022 annual meeting of the American Society of Hematology, Dr. John Allan (Weill Cornell Medicine) presented long-term follow-up data of the phase 2 CAPTIVATE study, a trial that evaluated the efficacy and safety of this combination, for which the primary results were presented previously.1,2 After completion of the pre-randomized combination therapy, patients were randomized 1:1 to continued ibrutinib or placebo. The current analysis focused on the comparison between these arms in a cohort of patients who displayed confirmed undetectable minimal residual disease (uMRD; N=86) after completion of the pre-randomized combination treatment.
Dr. Allan showed that the 3-year disease-free survival rates were high and not significantly different in the 2 arms of the study, with a rate of 85% in the placebo arm and a rate of 93% in the ibrutinib arm (HR, 0.44; 95% CI, 0.13-1.45; log-rank P=0.16). Furthermore, 36 months after randomization, MRD negativity was observed in 63% of patients on ibrutinib and in 58% on placebo. The 4-year progression-free survival rates were 95% and 88% in the ibrutinib arm and placebo arm, respectively. Finally, Dr. Allan noted that the incidence of adverse events post-randomization was low and that no new grade 3 or higher hemorrhagic events were reported.
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