Most patients with chronic lymphocytic leukemia (CLL) are elderly (70% are older than age 65 years ) and unfit, often with 1 or more comorbidities, thus making them ineligible for intensive chemoimmunotherapy regimens such as rituximab plus fludarabine and cyclophosphamide. The pivotal CLL11 trial (NCT01010061) established obinutuzumab (GA101 [G]; a type II, glycoengineered, anti-CD20 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity and improved direct B-cell killing ) plus chlorambucil (Clb) as a new standard of care for previously untreated CLL patients with comorbidities.
In CLL11, G-Clb demonstrated a greater effect on progression-free survival (PFS) and overall survival (OS) vs rituximab plus chlorambucil (R-Clb) and vs Clb alone.