- For the first time, people in Scotland with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a new chemotherapy-free option with a fixed treatment duration of 24 months.1
- SMC acceptance is based on the MURANO phase 3 clinical trial, in which venetoclax plus rituximab (VenR) reduced the risk of disease progression or death by eighty-three percent compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).1
- CLL is the most common form of adult leukaemia with over 3,500 people diagnosed every year in the UK.2,3
MAIDENHEAD, UK, 12th August 2019 – AbbVie (NYSE: ABBV) announced today that NHS patients in Scotland with relapsed/refractory chronic lymphocytic leukaemia (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 treatment duration of 24 months. The Scottish Medicines Consortium’s (SMC’s) acceptance follows The National Institute for Health and Care Excellence (NICE) recommendation for the combination therapy to be made available on the NHS in England and Wales on 18th January 2019.4
CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,5 Over 3,500 people are diagnosed with CLL in the UK each year.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur.6
Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care said: “We’re delighted the SMC has decided to make the venetoclax plus rituximab combination treatment available in Scotland on the NHS to people living with relapsed or refractory CLL. This decision has the potential to change outcomes in an area where we have seen few clinical advances until recently. Hearing your disease has relapsed or become refractory can be overwhelming for patients and their families, so the SMC’s decision to make available an effective chemotherapy-free option with a fixed treatment duration is very much welcomed by the patient community.”
The SMC’s 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 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).1
Dr Mike Leach, Consultant Haematologist at the Beatson West of Scotland Cancer Centre in Glasgow, said: “The SMC’s approval of venetoclax plus rituximab for the second line treatment of CLL is a significant step forward for patients in Scotland. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. It is capable of achieving deep levels of response with a fixed duration of therapy and allows treatment free periods for our CLL patients.”
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-), was a secondary endpoint. 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.7 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.1
Recent post treatment follow-up data has provided evidence on long-term outcomes for venetoclax in combination with rituximab. Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively.8
Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to developing and delivering breakthrough therapeutic options in CLL, an area where there is high unmet need and where there are few treatments available. We have worked closely with the SMC to bring venetoclax plus rituximab to patients in Scotland as quickly as possible. This is a very positive outcome for Scottish patients and today’s decision will motivate us further in our ongoing drive to improve patient outcomes in blood cancer.”
Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
- Ends -
The final SMC guidance can be accessed via the SMC website.
For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.
▼Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact firstname.lastname@example.org
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Notes to editors
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.9 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.9
In the MURANO phase 3 clinical trial, the most common adverse event of any grade in both the treatment and control groups was neutropenia (60.8% of the patients in the venetoclax–rituximab group and 44.1% of the patients in the bendamustine–rituximab group). The incidence of serious adverse events was similar in the two groups.1
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types.
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1 Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.
2 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: July 2019
3 Cancer Research UK. Chronic lymphocytic leukaemia (CLL): Risks and causes. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/risks-causes Accessed: July 2019
4 NICE. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/Guidance/TA561. Accessed: July 2019
5 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: July 2019
6 National Cancer Institute. Living as a Chronic Lymphocytic Leukemia Survivor. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/after-treatment/follow-up.html. Accessed: July 2019.
7 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018; 131(25):2745-2760
8 Seymour J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.
9 Venclyxto Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/32650. Accessed: July 2019