Valentin Goede, MD, from the University Hospital Cologne and the German CLL Study Group, discusses the efficacy findings from the stage 2 CLL11 study that examined obinutuzumab (Gazyva; formally GA101) plus chlorambucil in patients with chronic lymphocytic leukemia (CLL) with comorbidities.
In stage 2 of the phase III CLL11 trial, patients were randomized to receive either obinutuzumab plus chlorambucil (n = 333) or rituximab plus chlorambucil (n = 330). The primary endpoint of the study was progression-free survival (PFS).
In the study, the median PFS for the obinutuzumab combination was 26.7 months compared with 15.2 months with rituximab (HR = 0.39; P
< .0001). This dramatic difference in PFS indicates that obinutuzumab is superior to rituximab in this setting, Goede notes.
In addition to PFS, impressive efficacy findings were demonstrated for the combination of chlorambucil and obinutuzumab for other endpoints, Goede indicates. Overall, 21% of patients compared to 7% experienced a complete response, for obinutuzumab and rituximab, respectively. Also, Goede suggests, the number of patients testing MRD-negative in the obinutuzumab arm was 10-fold greater than in the rituximab arm, indicating a huge difference between the two treatments.
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