Insights From the CAPTIVATE Trial Final Analysis in CLL/SLL

The landscape of chronic lymphocytic leukemia (CLL) treatment continues to evolve, with targeted therapies offering unprecedented improvements in patient outcomes. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the final analysis of the CAPTIVATE trial (NCT02910583) was reported. Results from the study showed that fixed-dose ibrutinib (Imbruvica) plus venetoclax (Venclexta) continued to have durable progression-free survival rates and overall survival rates with long-term follow-up in patients with CLL/small lymphocytic lymphoma (SLL), including patients with high-risk genomic features.

In an interview with Targeted Oncology^TM, Paolo Ghia, MD, PhD, deputy director of the Division of Experimental Oncology at San Raffaele Scientific Institute in Milan, Italy; full professor of medical oncology; a group leader in the B-cell Neoplasia Unit; and the head of the Strategic Research Program on CLL at the Università Vita Salute San Raffaele, discusses the final analysis of the CAPTIVATE study (NCT02910583).

CAPTIVATE is a pivotal phase 2 trial that has reshaped our understanding and approach to frontline CLL management, particularly in younger patients. His insights delved into the innovative design and foundational principles that underpin this significant research.

“The CAPTIVATE study is a phase 2 study that enrolled young patients with chronic lymphocytic leukemia in the frontline setting. They were treated with 3 months of ibrutinib, a [Bruton's tyrosine kinase (BTK)] inhibitor, to debulk the patient, and then with 12 months of the combination of ibrutinib plus the BCL2 inhibitor venetoclax,” Ghia explains in the interview.

The study included two cohorts: a fixed-duration cohort and a minimal residual disease (MRD)-guided cohort, where treatment duration was adapted based on MRD status.

“This is indeed the treatment scheme that has been approved in Europe and in many other countries in the world, and now can be used in patients with chronic lymphocytic leukemia in the frontline,” says Ghia.

REFERENCE:

Ghia P, Barr PM, Allan JN, et al. Final analysis of fixed-duration ibrutinib + venetoclax for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in the phase 2 CAPTIVATE study. J Clin Oncol. 2025;43(suppl 16):7036-7036. doi: 10.1200/JCO.2025.43.16_suppl.7036