Randomized phase 3 study, as first-line chemoimmunotherapy in CLL patients with comorbidities.
Obinutuzumab (GA101) Plus Chlorambucil (Clb) Versus Rituximab Plus Clb.
GCib vs RCib ORR: 78% vs 65%, CR-21% vs 7%, median PFS- 26.7 vs 15.2 months: grade 3 adverse events: 66 vs 47%,infusion related reaction -20 vs 4%, neutropenia 33 vs 27%.
PFS benefit of GClb over RClb seen in all cytogenetic subgroups 17p-, 11q-, 12+, 13q-.
MRD negative blood samples at end-of-treatment, 10-fold higher with GClb group.