Home > Haematology > ASH 2022 > Ibrutinib plus venetoclax displays long-term benefits in CLL

Ibrutinib plus venetoclax displays long-term benefits in CLL

Presented By
Dr John Allan, Weill Cornell Medicine, NY, USA
ASH 2022

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 ASH 2022, Dr John Allan (Weill Cornell Medicine, NY, USA) presented long-term follow-up data of the phase 2 CAPTIVATE study (NCT02910583), 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-randomised combination therapy, patients were randomised 1:1 to continued ibrutinib or placebo. The current analysis focused on the comparison between these arms in a cohort of patients that displayed confirmed undetectable minimal residual disease (uMRD; n=86) after completion of the pre-randomised 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 randomisation, MRD negativity was observed in 63% of the patients on ibrutinib and in 58% of the patients on placebo. The 4-year progression-free survival rates were 95% and 88% in the ibrutinib arm and placebo arm, respectively. Finally, Dr Allan mentioned that the incidence of adverse events post-randomisation was low and that no new grade ≥3 haemorrhagic events were reported.

  1. Allan JN, et al. Treatment outcomes after undetectable MRD with first-line ibrutinib plus venetoclax: fixed-duration treatment (placebo) versus continued ibrutinib with up to 5 years follow-up in the CAPTIVATE study. Abstract 92, ASH 64th Annual Meeting, 10–13 December 2022, New Orleans, USA.
  2. Wierda WG, et al. J Clin Oncol. 2021;39(34):3853–3865.


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