Phase III MURANO study of Venclexta (venetoclax) plus Rituxan (rituximab) in relapsed or refractory chronic lymphocytic leukaemia meets primary endpoint.- Genentech/Roche.

Genentech/Roche Group announced that the Phase III MURANO study, which evaluated Venclexta (venetoclax) in combination with Rituxan (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing (progression-free survival [PFS] as assessed by investigator) when treated with Venclexta plus Rituxan compared to bendamustine plus Rituxan. No new safety signals or increase in known toxicities of Venclexta were observed with the treatment combination of Venclexta plus Rituxan.

Comment: 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 plan in the United States to convert the current accelerated approval of Venclexta to a full approval. Data from the MURANO study will be presented at an upcoming medical meeting and submitted to global health authorities.