Obinutuzumab (GA101) plus chlorambucil (Clb) versus rituximab plus Clb in patients with chronic lymphocytic leukaemia (CLL) and comorbidities: Recently published results of the CLL11 trial.

Abstract

CLL11 is a phase 3 trial investigating first-line chemoimmunotherapy in CLL patients with comorbidities. Here, we present published results of the head-to-head comparison between GA101 plus Clb (G-Clb) and rituximab plus Clb (R-Clb), and of the G-Clb versus Clb and R-Clb versus Clb comparisons. Treatment-naive CLL patients with a CIRS score >6 and/or a CrCl <70 ml/min were eligible. Patients received Clb alone (0.5 mg/kg po d1, d15 q28 days, 6 cycles), G-Clb (100 mg iv d1, 900 mg d2, 1000 mg d8, d15 of cycle 1, 1000 mg d1 cycles 2-6), or R-Clb (375 mg/m2 iv d1 cycle 1, 500 mg/m2 d1 cycles 2-6). The G-Clb and R-Clb treatment arms were well balanced for baseline characteristics. Median age, CIRS score, and CrCl at baseline were 73 years, 8, and 62 ml/min respectively. Key results of the G-Clb versus R-Clb comparison are shown in the table. The number of patients with MRD negative blood samples at end-of-treatment was significantly higher with G-Clb compared with R-Clb. OS analysis demonstrated a benefit of G-Clb over Clb alone. In conclusion, GA101, a novel, glycoengineered, type II CD20 antibody, in combination with Clb improved outcomes compared with R-Clb in previously untreated CLL patients with comorbidities. (Table presented) .