Patients receiving BR experienced higher grade 3/4 rates of anemia (14% vs 11%), thrombocytopenia (10% vs 6%), febrile neutropenia (10% vs 4%), pneumonia (8% vs 5%), infusion-related reaction (5% vs 2%), and hypotension (3% vs 0).
The FDA previously granted the venetoclax/rituximab combination a breakthrough therapy designation in January 2016. Additionally, the MURANO results are intended to support the conversion of the accelerated approval of single-agent venetoclax into a full approval for the treatment of patients with CLL who harbor a del(17p) and have received at least 1 prior therapy.
The breakthrough designation for venetoclax plus rituximab was based on data from the phase Ib M13-365 study. In the trial, the combination had an overall response rate of 86%, with deep and durable responses in patients with relapsed/refractory CLL.
Genentech (Roche) and AbbVie, the developers of venetoclax, reported in a press release that they plan to submit the MURANO findings to the FDA.
Seymour JF, Kipps TJ, MD2, Eichhorst BF, et al. Venetoclax plus rituximab is superior to bendamustine plus rituximab in patients with relapsed/ refractory chronic lymphocytic leukemia - results from pre-planned interim analysis of the randomized phase 3 Murano Study. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta, Georgia. Abstract LBA-2.