Results of Phase III Murano trial of Venclexta + Rituxan in chronic lymphocytic leukaemia published in NEJM.- AbbVie/Roche/Genentech.
Results from the Phase III Murano trial of Venclexta (venetoclax) from AbbVie, and Rituxan (rituximab), from Roche/Genentech, significantly improved progression-free survival (PFS) in patients with chronic lymphocytic leukaemia (CLL), according to data published in the New England Journal of Medicine. The results show that after a median follow-up period of 23.8 months, progression-free survival (PFS) was significantly higher in patients taking venetoclax/rituximab (with 32 events of progression or death in 194 patients) than in the bendamustine�rituximab group (114 events in 195 patients).
The two-year rates of progression-free survival were 84.9 percent and 36.3 percent, respectively. The rate of grade 3 or 4 neutropenia was higher in the venetoclax�rituximab group than in the bendamustine�rituximab group, but the rates of grade 3 or 4 febrile neutropenia and infections or infestations were lower with venetoclax than with bendamustine.
See: "Venetoclax�Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia" John F. Seymour et al. N Engl J Med 2018; 378:1107-1120 DOI: 10.1056/NEJMoa1713976
Comment: Data from the MURANO study will be submitted to global health authorities, including the FDA, 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.
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