AbbVie, a global research and development-based biopharmaceutical company, announced that the phase 3 MURANO study of Venclexta/Venclyxto (Venetoclax) tablets in combination with Rituxan (rituximab) met its primary endpoint. Results showed that Venclexta/Venclyxto in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) compared with bendamustine combined with Rituxan. An independent data monitoring committee reviewed this study and made the recommendation to unblind the trial based on the positive results. Doctors will continue to monitor patients who remain active in the MURANO trial in efforts to obtain additional, longer-term safety and efficacy information. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US. and by AbbVie outside of the US.

"AbbVie is committed to researching the full potential of Venclexta/Venclyxto both as monotherapy and combination therapy in patients with CLL and other hematologic malignancies. The analysis of the MURANO trial showed that Venclexta/Venclyxto in combination with Rituxan may offer another option for patients with R/R CLL, potentially providing them with a chemotherapy-free therapy," said Michael Severino, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "We are looking forward to working with regulatory authorities around the world to bring this additional treatment regimen to R/R CLL patients."

The most common type of leukemia in the Western world is CLL, which accounts for approximately one-quarter of new cases of leukemia in the U.S. CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (type of white blood cells) are found predominantly in the blood and bone marrow. CLL usually affects older patients, with more men than women affected. The median age at diagnosis is approximately 70 years.

Full data from this study will support regulatory submissions for Venclexta/Venclyxto in combination with Rituxan therapy in R/R CLL, and will be presented at an upcoming medical conference. Safety data, including serious and most common adverse events and discontinuation rates, are currently being analyzed.

The multicenter, open-label, randomized Phase 3 MURANO study was designed to evaluate the efficacy and safety of Venclexta/Venclyxto in combination with Rituxan compared with bendamustine in combination with Rituxan in patients with R/R CLL.4 The primary endpoint was investigator-assessed progression-free survival (PFS), which was determined using standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Secondary endpoints included Independent Review Committee (IRC)-assessed PFS, as well as PFS in patients with 17p deletion, best overall response (defined as complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or PR), overall survival, event-free survival, duration of response, time to next anti-CLL treatment, and percentage of patients achieving minimal residual disease negativity.