CAPTIVATE 5.5-year update: Fixed-duration ibrutinib + venetoclax in patients with CLL/SLL and high-risk genomic features or progressive disease

The phase II CAPTIVATE trial (NCT02910583) evaluated ibrutinib + venetoclax in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in two cohorts: measurable residual disease-guided cohort and fixed duration (FD) cohort. During the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, 5.5-year follow-up outcomes of patients with high-risk genomic features from the FD cohort and retreatment outcomes in patients with progressive disease (PD) were presented by Wierda.¹

After 5.5 years of follow-up, median progression-free survival (PFS) was not reached with FD ibrutinib + venetoclax.

While the 5-year PFS and overall survival rates for patients with high-risk genomic features were lower than those without, these patients had a clinically meaningful survival benefit with FD ibrutinib + venetoclax.

Among patients with PD following FD ibrutinib + venetoclax, retreatment with single-agent ibrutinib or ibrutinib + venetoclax led to durable responses with no new safety signals.

These findings support the use of ibrutinib + venetoclax, an all-oral, once-daily, chemotherapy-free FD regimen, as a first-line treatment for patients with CLL/SLL and highlight the positive benefit–risk profile of ibrutinib-based retreatment in patients who relapse.