Insights From the CAPTIVATE Trial on Frontline CLL Treatment Strategies

Paolo Ghia, MD, PhD, deputy director of the Division of Experimental Oncology in 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, provides an overview of the CAPTIVATE trial (NCT02910583), uncovering what investigators sought to evaluate.

In the CAPTIVATE trial, ibrutinib (Imbruvica) plus venetoclax (Venclexta) was evaluated for the treatment of patients with chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL). Patients with previously untreated CLL aged 71 years or younger were included in the study. This included patients with high-risk disease. Two cohorts made up the study.

According to Ghia, the regimen continued to demonstrate a clinically meaningful progression-free survival at 5.5-years of follow-up in both the overall population and in those with high-risk genomic features

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0:09 | The CAPTIVATE trial is a phase 2 international trial where we investigated the combination of ibrutinib, the BTK inhibitor, and venetoclax, a BCL2 inhibitor, in frontline patients with CLL. And in particular, this combination was given with 3 months of debulking with the ibrutinib only, and then 12 months of the combination between ibrutinib and venetoclax. The study involved only young patients below 70 years of age.

0:41 | There were 2 different cohorts, not arms. They were not randomized to each other. One cohort was MRD driven, so at the end of the 15 months of treatment, patients were randomized based on the level of undetectable MRD. But more importantly, we had the so-called fixed-duration cohort, where patients after 15 months of treatment all stopped the treatment regardless of the level of undetected MRD. And that is actually the regimen that has been approved in Europe, and it can be used now as a standard regimen.