Dr Ghia on a Pooled Analysis of OS Outcomes With Ibrutinib Plus Venetoclax in CLL

“The OS estimates in this population were similar to [that of] the age-matched general European population, and that was true for both young and elderly patients.”

Paolo Ghia, MD, PhD, full professor, medical oncology, Università Vita-Salute San Raffaele; head, Laboratory of B-Cell Neoplasia, director, Strategic Research Program on CLL, ORCCS Ospedale San Raffaele, discusses the overall survival (OS) outcomes from a pooled analysis evaluating the efficacy of first-line, fixed-duration ibrutinib (Imbruvica) plus venetoclax (Venclexta) in patients with treatment-naive chronic lymphocytic leukemia (CLL).

The analysis compared the outcomes of patients treated with the combination in the phase 3 GLOW trial (NCT03462719) and the fixed-duration cohort of the phase 2 CAPTIVATE study (CAPTIVATE-FD; NCT02910583) with that of an age-matched general European population. Findings were presented at the 2024 ASH Annual Meeting.

The 46-month follow-up of GLOW showed that patients with CLL who received fixed-duration frontline ibrutinib plus venetoclax had improved OS outcomes vs those who received chlorambucil plus obinutuzumab (Gazyva; HR, 0.487; P = .021). Previously reported findings from CAPTIVATE-FD demonstrated that, at a median follow-up of 61.2 months, the OS rate was 96% with ibrutinib plus venetoclax.

The pooled analysis included 265 patients (GLOW, n = 106; CAPTIVATE-FD, n = 159) and showed that the OS estimates among patients from these trials who received fixed-duration ibrutinib plus venetoclax were similar to an age-matched general European population across age groups and irrespective of immunoglobulin gene mutation status, Ghia begins. In the overall study population, the estimated 36-, 48-, and 60-month OS rates were 95%, 93%, and 91%, respectively, and were comparable with those seen in the general population (HR, 0.999; 95% CI, 0.567-1.761; P = .998). Among patients treated with the combination who were at least 65 years of age (n = 135), the estimated 36-, 48-, and 60-month OS rates were 92%, 90%, and 88%, respectively, and were comparable with those for the age-matched general population (HR, 0.828; 95% CI, 0.422-1.623; P = .582). Among patients treated with the combination who were younger than 65 years of age (n = 130), the estimated 36-, 48-, and 60-month OS rates were 97%, 96%, and 93%, respectively, and were also comparable with those for the age-matched general population (HR, 1.636; 95% CI, 0.549-4.875; P = .377).