Patients with hard-to-treat chronic lymphocytic leukemia (CLL) lived longer without disease progression when treated with a combination of venetoclax (Venclexta, AbbVie/Genentech) and rituximab (Rituxan, Biogen/Genentech) than when treated with a combination of bendamustine and rituximab, a new study shows.
The phase 3 MURANO study, which evaluated venetoclax in combination with rituximab in people with relapsed or refractory CLL, met its primary endpoint and showed a statistically significant improvement in progression-free survival (PFS) as assessed by investigators when patients were treated with venetoclax and rituximab compared with bendamustine and rituximab. No new safety signals or increase in known toxicities of venetoclax were observed with the combination.
The FDA has granted a breakthrough therapy designation for the venetoclax/ rituximab combination for the treatment of relapsed or refractory CLL based on results from the phase 1b M13-365 study. Venetoclax 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.
Data from the MURANO study will be presented at an upcoming medical meeting and submitted to global health authorities. MURANO (NCT02005471) is a phase 3, open-label, international, multicenter, randomized study that included 389 patients with relapsed or refractory CLL who had been treated previously with at least one but not more than three lines of therapy. Patients were randomly assigned in a 1:1 ratio to receive either venetoclax and rituximab (Arm A) or bendamustine plus rituximab (Arm B). The primary endpoint of the study is investigator-assessed PFS. 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, and minimal residual disease status.
Source: Genentech; September 18, 2017.