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CAPTIVATE: Ibrutinib plus venetoclax shows ongoing efficacy in CLL

Presented by
Dr Paolo Ghia, Università Vita-Salute San Raffaele, Italy
ASH 2021
The first-line, chemotherapy-free regimen of ibrutinib plus venetoclax showed ongoing efficacy after 2 years of follow-up in patients with chronic lymphocytic leukaemia (CLL). Patients with confirmed undetected measurable residual disease (uMRD) did not display MRD relapses, death, or progressive disease during the follow-up phase of the phase 2 CAPTIVATE trial. These results suggest that treatment-free remission may be achieved with a first-line, fixed-duration ibrutinib plus venetoclax regimen in patients with CLL [1].

The international, multicentre, phase 2 CAPTIVATE trial (NCT02910583) investigated an ibrutinib plus venetoclax regimen in patients with CLL (n=323), divided into a fixed-duration cohort and an MRD cohort. Patients received 3 cycles of oral ibrutinib (420 mg, daily), followed by 12 cycles of ibrutinib plus oral venetoclax (ramp-up to 400 mg daily). Dr Paolo Ghia (Università Vita-Salute San Raffaele, Italy) presented the 2-year follow-up results of the MRD cohort.

During cycle 16, patients with confirmed uMRD were randomised 1:1 to placebo (n=43) or ibrutinib monotherapy (n=43). Patients who did not achieve uMRD were randomised 1:1 to ibrutinib monotherapy (n=31) or ibrutinib plus venetoclax therapy (n=32). Notably, a high proportion of patients had high-risk features, such as unmutated immunoglobulin heavy-chain variable region gene (IGHV) (60%). The median post-randomisation follow-up was 24 months. Median treatment duration was 37 months in all patients.

No new disease-free survival (DFS) events had occurred since the primary analysis in patients with confirmed uMRD. The DFS rates remained at 95% and 100% for placebo and ibrutinib receivers, respectively. In addition, the overall study period displayed modest improvements in complete response (CR) rates for patients with confirmed uMRD compared with the pre-randomisation period (placebo 9%; ibrutinib 5%). Patients without confirmed uMRD showed larger improvements in CR rates, with ibrutinib receivers displaying a 22% improvement and ibrutinib plus venetoclax receivers demonstrating a 28% improvement. Furthermore, preliminary data suggested that patients who experience a progressive event may be re-treated with ibrutinib monotherapy. No new safety issues of the ibrutinib plus venetoclax regimen were observed.

  1. Ghia P, et al. First-Line Treatment with Ibrutinib (Ibr) Plus Venetoclax (Ven) for Chronic Lymphocytic Leukemia (CLL): 2-Year Post-Randomization Disease-Free Survival (DFS) Results from the Minimal Residual Disease (MRD) Cohort of the Phase 2 Captivate Study. Abstract 68, ASH 2021 Annual Meeting, 11‚Äď14 December.


Want to read more? Medicom has a featured interview with Dr Paolo Ghia (Università Vita-Salute San Raffaele, Italy) about the CAPTIVATE trial: Ibrutinib plus venetoclax show stunning efficacy in CLL.


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