Fixed-duration ibrutinib plus venetoclax studied in first-line CLL

Updated results from a pooled analysis of the fixed-duration cohorts of the phase 3 GLOW trial (NCT03462719) and the phase 2 CAPTIVATE study (NCT02910583), which evaluated first-line fixed-duration ibrutinib/Ibrutinib (Ibrutinib) is the combination of venetoclax (venetoclax) in the treatment of patients with newly diagnosed chronic lymphocytic leukemia (CLL). Additional information, as well as information gained from [earlier] studies, shows long-term efficacy and durability in progression-free survival, which is very long, [including] in patients with high-risk characteristics.

Study results published in 2024 showed that fixed-duration ibrutinib plus venetoclax was associated with overall survival (OS) outcomes that were close to those in the age-matched general European population. The pooled analysis included 265 patients who received combination therapy (GLOW, n=106; CAPTIVATE, n=159) and assessed OS rates at 36, 48, and 60 months.

In the overall population, the estimated OS rates were 95% at 36 months, 93% at 48 months, and 91% at 60 months. These values u200bu200bare consistent with those observed in the general European population, with no significant difference in OS (HR, 0.999; 95% CI, 0.567-1.761; P=0.998). The analysis further stratified the results by age group. Among patients 65 years and older (n=135), the estimated OS rates at 36, 48, and 60 months were 92%, 90%, and 88%, respectively (HR, 0.828; 95% CI, 0.422-1.623; P=0.582). For patients younger than 65 years old (n=130), the corresponding OS rates were 97%, 96%, and 93%, respectively (HR, 1.636; 95% CI, 0.549-4.875; P=0.377).

The survival benefit of ibrutinib plus venetoclax was observed regardless of IGHV mutation status. Both IGHV-mutated and unmutated subgroups experienced similar OS trajectories, supporting the broad applicability of this fixed-duration regimen across risk groups.

Reference materials:https://www.onclive.com/view/dr-ghia-on-fixed-duration-ibrutinib-plus-venetoclax-in-first-line-cll