Phase III CLL14 study of Venclexta + Gazyva shows high response rate in chronic lymphocytic leukemia.- Genentech/Roche

Genentech/Roche announced updated data from a pivotal Phase III CLL14 study that highlights Venclexta (venetoclax) plus Gazyva (obinutuzumab) combination treatment as chemotherapy-free, fixed-duration options that achieve minimal residual disease (MRD)-negativity, in people with chronic lymphocytic leukemia (CLL). The pivotal Phase III CLL14 study evaluated the combination of Venclexta plus Gazyva in people with previously untreated CLL, who had co-existing medical conditions.

At a median follow-up of more than three years (39.6 months), when all patients had been off therapy for a minimum of two years, Venclexta plus Gazyva showed high response rates, including MRD-negativity. Specifically higher rates of MRD-negativity in peripheral blood (76 percent vs. 35 percent; p<0.001) and bone marrow (57 percent vs. 17 percent; p><0.001) were observed at the end of treatment in people treated with venclexta plus gazyva versus gazyva plus chlorambucil, respectively. mrd-negativity indicates that no cancer can be detected using a specific, highly sensitive test, and was defined as less than one cll cell in 10,000 white blood cells. mrd-negativity was observed in 42 percent of people treated with venclexta plus gazyva who achieved a complete response (cr) in the peripheral blood, and 14 percent of people treated with gazyva plus chlorambucil (p><0.001). in bone marrow, mrd-negativity was observed in 34 percent of people who achieved a complete response with venclexta plus gazyva and 11 percent of people treated with gazyva plus chlorambucil (p><0.001).>

At this updated analysis, the fixed-duration, chemotherapy-free combination of Venclexta plus Gazyva reduced the risk of disease worsening or death by 69 percent compared to Gazyva plus chlorambucil (PFS, as assessed by investigator; HR=0.31; 95 percent CI: 0.22-0.44; p<0.0001). the most common grade 3-4 adverse events (aes) in people treated with venclexta plus gazyva were blood and lymphatic system disorders, and infections. these data and others from the venclexta clinical development program will be featured in more than 50 abstracts at the 61st american society of hematology (ash) annual meeting.>

Comment: Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to restore the process of apoptosis.