The FDA has approved the combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) for the frontline treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The approval is based on findings from the phase III CLL14 trial, in which the venetoclax combination reduced the risk of disease progression or death by 67% versus obinutuzumab plus chlorambucil in patients with treatment-naïve CLL and co-existing medical conditions (HR, 0.33; 95% CI, 0.22-0.51; P<.0001).
The overall response rate (ORR) was 85% (95% CI, 79%-89%) with venetoclax/obinutuzumab versus 71% (95% CI, 65%-77%) in the control arm (P = .0007). The complete response or complete response with incomplete hematologic recovery rates were 50% versus 23% respectively (P <.0001).
The rate of minimal residual disease (MRD)-negativity in the bone marrow was 57% in the venetoclax arm compared with 17% in the obinutuzumab/chlorambucil arm. The MRD-negativity rates in the peripheral blood were 76% versus 35%, respectively.
“Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard of care,” Sandra Horning, MD, chief medical officer and head of Global Product Development, at Roche (Genentech), which manufactures venetoclax and obinutuzumab, said in a press release.
In the phase III CLL14 trial (NCT02242942), the combination of fixed-duration venetoclax and obinutuzumab was compared with obinutuzumab and chlorambucil in 432 treatment-naïve patients with CLL and coexisting medical conditions. Patients were randomized to receive 12 months of venetoclax alongside 6 months of obinutuzumab (arm A) or 6 months of obinutuzumab followed by 6 months of chlorambucil (arm B).
Complete results of the study are scheduled to be presented early next month at the 2019 ASCO Annual Meeting.
This article was originally published on OncLive as, "FDA Approves Venetoclax/Obinutuzumab Combo for Frontline CLL."