Efficacy and tolerability of venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia - real-world analysis of Polish adult leukemia study group.

Abstract

We collected clinical data on 363 patients with relapsed/refractory chronic lymphocytic leukemia (RR-CLL) treated with venetoclax-rituximab (VR) in a real-world setting. The median age was 69.5 years (range, 32.5-91.6 years), and the median number of prior lines of therapy was 2 (range, 1-10). Fifty-three recipients (53/362, 13.8%) had previously received BTKi. The median follow-up was 22.8 months. The overall response rate was 97.1%. The median PFS and OS were not reached. The estimated 3 y-PFS rate was 62.1% (95% CI 54.9-70.2), and the 3 y-OS rate was 69.0% (95% CI 62.3-76.4). Eighty-five (23.5%) patients had completed their therapy, while 106 (29.4%) discontinued prematurely. Reasons for therapy discontinuation included mainly patients' death (n = 36, 34%) and cytopenias (n = 17,16.0%). Treatment outcomes with the VR regimen in a real-life setting were slightly worse than those reported in the MURANO trial, likely due to the inclusion of patients with advanced ECOG and prior BTKi treatment.