Genentech announced 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 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 as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil.
Genentech is a member of the Roche Group.
The results showed that no new safety signals or increase in known toxicities of Venclexta or Gazyva were observed with the treatment combination, the company said.
Data from the CLL14 study will be submitted to global health authorities. Venclexta in combination with Rituxan (rituximab) has been approved by the 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 is currently under review by 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 who are ineligible for intensive chemotherapy, with a decision expected by end of year.
A clinical development program for Venclexta is ongoing in several types of blood cancer, including AML and multiple myeloma. Gazyva continues to be investigated in combination with approved and investigational molecules in CLL and follicular lymphoma.
Venclexta is being developed by AbbVie and Genentech. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the U.S.
CLL14 (NCT02242942) is a randomized phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia with coexisting medical conditions.
432 patients with previously untreated CLL were randomly assigned to receive either Venclexta plus Gazyva (Arm A) or Gazyva plus chlorambucil (Arm B). The primary endpoint of the study is investigator-assessed progression free survival.
Secondary endpoints include PFS assessed by independent review committee, best overall response, complete response, duration of response, overall survival, event-free survival, time to next CLL treatment, minimal residual disease status and safety.
