NHS Scotland has accepted the use of combination-free treatment VENCLYXTO® (venetoclax) plus rituximab for people with previously treated Chronic Lymphocytic Leukemia.
AbbVie announced that NHS patients in Scotland with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy will now have access to venetoclax plus rituximab; a new chemotherapy-free option with a fixed duration of 24 months. The Scottish Medicines Consortium (SMC) acceptance follows the National Institute for Health Care Excellence (NICE) recommendation for the combination therapy to be made available on the NHS in England and Wales on 18th January 2019.
Approval Based on MURANO Trial
The Phase III MURANO clinical trial included the testing of venetoclax plus rituximab (VenR) which reduced the risk of disease progression or death by 83% compared to the standard of a care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).
The Scottish Medicines Consortium (SMC) positive Final Advice is based on results from the pivotal phase 3 MURANO clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared to a standard of a care chemoimmunotherapy regimen of bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature).
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-), was a secondary endpoint. The undetectable minimal residual disease is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. At the nine-month time point, sixty-two percent (n=121/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus thirteen percent (n=26/195) who received bendamustine plus rituximab.
CLL is the most common form of adult leukemia with over 3,500 people diagnosed each year in the UK.
It is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside the U.S.