Phase III CLL14 study of Venclexta + Gazyva meets primary endpoint in chronic lymphocytic leukemia.- Genentech/Roche.

Genentech/Roche announced that the randomized Phase III CLL14 study, which evaluated fixed-duration Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival [PFS] as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil. The results showed that no new safety signals or increase in known toxicities of Venclexta or Gazyva were observed with the treatment combination. Data from the CLL14 study will be submitted to global health authorities.

Venclexta in combination with Rituxan (rituximab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. A supplemental New Drug Application (sNDA) is currently under review by the FDA for Venclexta in combination with a hypomethylating agent or in combination with low dose cytarabine for the treatment of people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, with a decision expected by end of year.