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Obinutuzumab-venetoclax combination extends PFS in treatment-naive chronic lymphocytic leukemia
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A randomized phase 3 trial designed to compare venetoclax plus obinutuzumab with the standard regimen of obinutuzumab plus chlorambucil for patients with untreated chronic lymphocytic leukemia met its primary endpoint of investigator-assessed PFS, according to the agent’s manufacturer.
The CLL114 study included 445 patients with treatment-naive chronic lymphocytic leukemia and coexisting medical conditions.
Patients assigned to the experimental regimen received venetoclax (Venclexta; AbbVie, Genentech) — a selective inhibitor of BCL-2 protein — for a fixed duration of 12 months and six cycles of obinutuzumab (Gazyva, Genentech), an anti-CD20 monoclonal antibody.
The trial met its primary endpoint of PFS using the International Workshop on Chronic Lymphocytic Leukemia criteria.
The combination of venetoclax and obinutuzumab exhibited a safety profile consistent with the known profiles of each agent alone.
Full results will be presented at a future medical meeting.
Venetoclax already is approved in the United States for treatment of patients with CLL or small lymphocytic lymphoma who have received at least one prior treatment.
“Patients with chronic lymphocytic leukemia generally face a lifetime of continuous treatment to keep their disease from recurring or relapsing. The positive results from the CLL14 trial further demonstrate the potential of venetoclax as a treatment with a fixed duration for patients with chronic lymphocytic leukemia, and may serve as the basis to expand into first-line treatment,” Michael Severino, MD, executive vice president for research and development and chief scientific officer of AbbVie, said in a company-issued press release. “We look forward to sharing full results from the CLL14 trial, and to advancing other clinical development programs in our pipeline that have the potential to continue transforming the standards of care for patients with blood cancers.”