Genentech says Venclexta, Rituxan reduces risk of disease progression or death in Leukemia patients
Genentech, a member of the Roche Group (RHHBY), announced the first results from the pivotal Phase III MURANO study evaluating Venclexta plus Rituxan compared to bendamustine plus Rituxan for the treatment of people with relapsed or refractory chronic lymphocytic leukemia.
The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 83% compared with BR.
No new safety signals were observed. Venclexta is being developed by AbbVie (ABBV) and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
Data from the MURANO study will be submitted to global health authorities, including the U.S. Food and Drug Administration, which has granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL based on promising results from the Phase Ib M13-365 study.
Venclexta was granted accelerated approval by the FDA in April 2016 for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
The MURANO study is part of the company’s commitment in the United States to convert the current accelerated approval of Venclexta to a full approval.
MURANO is a Phase III open-label, international, multicenter, randomized study evaluating the efficacy and safety of Venclexta in combination with Rituxan compared to bendamustine in combination with Rituxan.
All treatments were of fixed duration. The study included 389 patients with relapsed or refractory chronic lymphocytic leukemia who had been previously treated with at least one, but not more than three, lines of therapy.
Patients were randomly assigned in a 1:1 ratio to receive either Venclexta plus Rituxan or BR.
The primary endpoint of the study is investigator-assessed progression-free survival. Secondary endpoints include PFS assessed by independent review committee, overall response rate, complete response rate, overall survival, minimal residual disease status, duration of response, event-free survival and time to next CLL treatment.
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