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Ibrutinib, a Bruton's tyrosine kinase inhibitor (BTKi), and venetoclax, a B-cell lymphoma 2 inhibitor, have various and complementary mechanisms of action that target cell compartments and subpopulations of chronic lymphocytic leukemia (CLL) to eliminate both dividing and resting CLL cells. Ibrutinib in combination with venetoclax has been seen to provide clinically relevant benefits to patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Three-year follow-up data from the CAPTIVATE (NCT02910583) trial were previously summarized by the Lymphoma Hub. Here, we report 4-year follow-up results presented at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting.
CAPTIVATE is an ongoing, international, multicenter phase II study investigating ibrutinib plus venetoclax as first-line treatment for patients with CLL or SLL.1 Full details of the study design are previously summarized on the Lymphoma Hub. Eligible patients were
The study endpoints included 4-year rate of complete response (CR) including investigator-assessed CR, overall response rate, duration of response, undetectable minimal residual disease rates (10−4 by flow cytometry), progression-free survival (PFS), overall survival (OS), and safety.
Figure 1. Efficacy outcomes*
CR, complete response; CI, confidence interval; dMRD, detectable MRD, FD, fixed-duration; MRD, minimal residual disease; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; uIgHV, unmutated immunoglobulin heavy chain variable; uMRD, undetectable MRD.
*Adapted from Barr.1
In total, 19 patients with progressive disease initiated retreatment with ibrutinib, with a median retreatment duration of 11 months; 17 of these patients responded to treatment with one achieving CR, 13 with partial response, one partial response with lymphocytosis, one stable disease, and one progressed disease. No adverse events leading to dose reduction/discontinuation were reported.
In addition to the adverse events reported in previous years, one serious adverse event, prostate cancer, occurred in this additional year of follow-up.
With 4 years of follow-up, fixed-duration ibrutinib plus venetoclax continued to provide clinically meaningful, deep, and durable response with manageable safety profile in patients with previously untreated CLL/SLL, including patients with high-risk disease features. Overall, the results support the use of fixed-duration ibrutinib plus venetoclax in in patients with previously untreated CLL/SLL.
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CAPTIVATE 3-year update: fixed-duration ibrutinib + venetoclax in CLL/SLL
The 3-year follow-up of the FD cohort showed that I + V continues to demonstrate deep and durable responses, with a clinically meaningful PFS rate of 88% which included...
William Wierda | ASCO 2018 | Ibrutinib and venetoclax combination for first-line CLL: CAPTIVATE phase II trial
William Wierda | Ibrutinib and venetoclax combination for first-line CLL: CAPTIVATE phase II trial
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