Paolo Ghia, MD, discusses the implications of the long-term follow-up of the CAPTIVATE trial investigating ibrutinib and venetoclax in CLL.
The phase 2 CAPTIVATE study (NCT02910583) investigated a first-line, all-oral regimen of ibrutinib (Imbruvica) and venetoclax (Venclexta) with a fixed duration for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This analysis, with up to 5.5 years of follow-up, explored the impact of baseline lymph node (LN) size on treatment outcomes.
In an interview with Targeted OncologyTM, Paolo Ghia, MD, 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, discusses the research.
The study found that patients with larger baseline LNs (≥5 cm) achieved similarly high rates of undetectable minimal residual disease (uMRD4) in both peripheral blood and bone marrow at the end of treatment compared to those with smaller LNs (<5 cm). While complete response rates were lower in the larger LN group, long-term progression-free survival (PFS) and overall survival rates were comparable between the 2 groups.
Interestingly, the depth of LN reduction at the end of treatment (≤1.5 cm vs. ≤2 cm) did not significantly impact long-term PFS. Instead, achieving uMRD4 at the end of treatment was the strongest predictor of sustained PFS, regardless of the extent of LN response. The study also noted that the safety profile of the combination was similar in patients with and without bulky lymph nodes at baseline.
In conclusion, fixed-duration ibrutnib/venetoclax demonstrates durable efficacy in first-line CLL/SLL, with long-term outcomes strongly linked to achieving uMRD, irrespective of initial lymph node size. The regimen was well-tolerated in both patient subgroups.