Anthony R. Mato, MD, MSCE, hematologic oncologist, director, CLL Program, Memorial Sloan Kettering Cancer Center, discusses the phase III CLL14 trial in patients with previously untreated chronic lymphocytic leukemia (CLL).

The CLL14 trial explores the combination of venetoclax (Venclexta) plus obinutuzumab (Gazyva) versus obinutuzumab plus chlorambucil in patients with previously untreated CLL. The patient population consisted of mostly older, unfit patients. The primary endpoint of the study was progression-free survival (PFS), which was met.

The trial demonstrated venetoclax/obinutuzumab was superior to obinutuzumab/chlorambucil in terms of PFS; however, there was no clear benefit in overall survival. The CLL14 trial indicated, for the first time in the frontline setting, that a fixed duration of venetoclax-based combination therapy can be given to achieve deep and durable remissions. The venetoclax/obinutuzumab combination was FDA approved in May 2019 and has become a standard of care in the frontline setting for patients with CLL or small lymphocytic lymphoma.