Dr Ghia on OS Outcomes With Ibrutinib/Venetoclax in CLL Relative to a Matched Healthy Population

“What we wanted to explore was how the use of this combination is affecting the life expectancy of patients with CLL compared with the normal, healthy population in the European community.”

Paolo Ghia, MD, PhD, a full professor in medical oncology at the Università Vita-Salute San Raffaele; as well as the head of the Laboratory of B-Cell Neoplasia and the director of the Strategic Research Program on CLL at the IRCCS Ospedale San Raffaele, discussed the rationale for conducting an analysis comparing overall survival (OS) with first-line fixed-duration ibrutinib (Imbruvica) plus venetoclax (Venclexta) in patients with CLL with that of an age-matched healthy European population.

The first-line combination of ibrutinib and venetoclax has been evaluated in 2 distinct clinical trials involving patients with CLL, Ghia began. The phase 3 GLOW study (NCT03462719) assessed this combination in an older patient population by comparing fixed-duration ibrutinib plus venetoclax vs chlorambucil plus obinutuzumab (Gazyva). The phase 2 CAPTIVATE study (NCT02910583) investigated the same regimen in younger patients under the age of 70 years. In both trials, treatment began with a lead-in phase of ibrutinib monotherapy for 3 cycles, followed by 12 cycles of combination therapy with both agents. The objective of the pooled analysis of these 2 trials, which werepresented at the 2024 ASH Annual Meeting, was to determine the effect of ibrutinib plus venetoclax on life expectancy in patients with CLL relative to the expected survival of a demographically matched, healthy European population.

Among the 265 patients with CLL included in this analysis, the median age at randomization was 65 (range, 57-70). The OS estimates were comparable between the patients with CLL and the age-matched general European population (HR, 0.999; 95% CI, 0.567-1.761; P = .998). The estimated 36-, 48-, and 60-month OS rates among the pooled CLL population were 95%, 93%, and 91%, respectively.