Ibrutinib plus venetoclax displays long-term benefits in CLL 

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), showing no difference in disease-free survival after 41 months between patients that continued on placebo or ibrutinib.

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, Prof. 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.

Prof. 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 participants on ibrutinib and in 58% of those on placebo. The 4-year progression-free survival rates were 95% and 88% in the ibrutinib arm and placebo arm, respectively. Finally, Prof. Allan mentioned that the incidence of adverse events post-randomisation was low and that no new grade ≥3 haemorrhagic events were reported.

In conclusion, the combination regimen of ibrutinib and venetoclax resulted in deep and durable response in newly diagnosed patients with CLL.

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 64^th Annual Meeting, 10–13 December 2022, New Orleans, LA, USA.
2. Wierda WG, et al. J Clin Oncol. 2021;39(34):3853–3865.

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Posted on 20 February 2023