Scottish Medicines Consortium Accepts Chemotherapy-free Combination Treatment VENCLYXTO®▼(Venetoclax) Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukaemia

PRESS RELEASE

 

Scottish Medicines Consortium Accepts Chemotherapy-free Combination Treatment VENCLYXTO^®▼(Venetoclax) Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukaemia

 

• Patients in Scotland with previously untreated chronic lymphocytic leukaemia (CLL) now have access to a chemotherapy-free, 12-month, fixed-duration treatment option.[1]
• Scottish Medicines Consortium (SMC) acceptance is based on data from the Phase III CLL14 trial, which showed patients receiving 1 year of treatment with venetoclax plus obinutuzumab had superior progression-free survival compared with those receiving a commonly used chemo-immunotherapy regimen of obinutuzumab and chlorambucil, with patients sustaining that benefit after stopping treatment.[2]^,[3]
• CLL is the most common form of adult leukaemia (blood cancer), with an estimated 211 people per 100,000 diagnosed in Scotland every year.[4]^,[5]

 

 

The SMC recommendation means that all patients with previously untreated CLL will now have access to a chemotherapy-free, 12-month, fixed-duration treatment that has been demonstrated to improve outcomes, giving patients the potential to live significantly longer without their disease progressing.²

 

CLL is the most common type of chronic blood cancer, with an estimated 211 people per 100,000 diagnosed in Scotland every year. Unlike some cancers, CLL has a highly variable clinical course, meaning patients are usually placed on ‘watch and wait’, after which some patients will be offered appropriate treatment.^4-[6] This decision means that eligible patients will have access to an additional initial chemotherapy-free treatment option that offers a fixed-duration treatment period.³

 

In response to the decision, Dr Mike Leach, consultant haematologist, The Beatson West of Scotland Cancer Centre, said “Following the SMC’s decision to provide more CLL patients in Scotland with access to the venetoclax plus obinutuzumab combination therapy, this will mean a greater number of patients could benefit from a treatment option that can offer a deeper clinical response and extended remission as well as fewer chemotherapy-related side effects”.

 

Marc Auckland, chairperson, CLL Support, said “The SMC’s announcement to make venetoclax plus obinutuzumab combination therapy available to all eligible patients with CLL within NHS Scotland is welcome news.”

 

Belinda Byrne, medical director at AbbVie, commented “This development is an important milestone for patients living with CLL. As a company that is passionate about improving patient outcomes in blood cancer, we are delighted with the SMC decision to make venetoclax plus obinutuzumab available for eligible patients with CLL in Scotland. CLL is an area where there is high unmet need and few treatment options available, so we are proud to do our part to improve the treatment landscape for this patient community”.

 

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 –

 

For the venetoclax Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

 

▼ Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AbbVie UK Ltd. Please contact GBPV@abbvie.com.

 

AbbVie UK media:

Sophia James                             Rebecca Goldberg

+44 (0)7977 055 997                    +44 (0)203 900 6100

sophia.e.james@abbvie.com             Rebecca.Goldberg@virgohealth.com

 

 

NOTES TO EDITORS

 

About venetoclax
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.[7]^,[8] 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.^7,8

 

About CLL

CLL is the most common type of chronic blood cancer and it affects the white blood cells. In CLL, the material found inside some bones (bone marrow) produces too many white blood cells called lymphocytes that are not fully developed and do not work properly.^4,[9] Over time this can cause a range of problems, such as an increased risk of picking up infections, persistent tiredness, swollen glands, and unusual bleeding or bruising.⁹

 

CLL is associated with a highly heterogeneous disease; this is partly due to genetic abnormalities identified in CLL cells such as mutations of TP53 and/or deletions in chromosome 17p [del (17p)]. The presence of these abnormalities is associated with decreased survival and predict impaired response to chemo-immunotherapy.[10]

 

About the Phase 3 CLL14 trial²

The prospective, multicentre, open-label, randomised Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax plus obinutuzumab (n = 216) versus obinutuzumab plus chlorambucil (n = 216) in previously untreated patients with CLL and coexisting medical conditions. The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The primary endpoint was progression-free survival (PFS) based on investigator assessment. Key secondary endpoints were PFS as assessed by an independent review committee, minimal residual disease (MRD)-negativity in peripheral blood and bone marrow, overall and complete response rates (ORR and CR rates, respectively), MRD-negativity in CR in peripheral blood and bone marrow, and overall survival.

 

The trial confirmed sustained PFS of the venetoclax combination versus obinutuzumab plus chlorambucil as shown at the 28.1 month follow-up.² At 4 years, in an updated efficacy analysis, the estimated PFS rate for the venetoclax combination was 74.0%, compared with the PFS of 35.4% for patients taking commonly used chemoimmunotherapy chlorambucil-obinutuzumab (ClbG). Median PFS with venetoclax combination (n = 216) was not reached and was 36.4 months with ClbG (n = 216).³ The most common adverse reactions in the venetoclax combination studies were neutropenia, diarrhoea and upper respiratory tract infection. The most frequently reported serious reactions were pneumonia, sepsis, febrile neutropenia and tumour lysis syndrome.^7,8

 

About AbbVie in Oncology

At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit https://www.abbvie.co.uk/our-science/therapeutic-focus-areas/Oncology.html.

 

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples’ lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter or YouTube.

 

 

 

[1].    Scottish Medicines Consortium. venetoclax (Venclyxto®) is accepted for restricted use within NHSScotland. Available from: https://www.scottishmedicines.org.uk/medicines-advice/venetoclax-venclyxto-full-smc2427/ [Accessed: May 2022].

[2].    Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019;380:2225–2236.

[3].    Al-Sawaf O, Zhang C, Robrecht S. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 4-year follow-up analysis of the randomized CLL14 study. Hematological Oncology. 2021;39.

[4].    Blood Cancer UK. Chronic lymphocytic leukaemia (CLL). Available from: https://bloodcancer.org.uk/understanding-blood-cancer/leukaemia/chronic-lymphocytic-leukaemia/ [Accessed: May 2022].

[5].    Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence#heading-Zero [Accessed: May 2022].

[6].    Leukaemia Care. Left to #WatchWaitWorry. Available from: https://www.leukaemiacare.org.uk/our-campaigns/watch-wait-worry/ [Accessed: May 2022].

[7].    AbbVie Inc. Venclyxto (venetoclax): Summary of Product Characteristics (EU). Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto [Last accessed: May2022].

[8].    AbbVie Inc. Venclyxto (venetoclax): Summary of Product Characteristics (Great Britain). Available from: https://www.medicines.org.uk/emc/medicine/32650#gref [Accessed: May 2022].

[9].    Leukaemia Care. Chronic Lymphocytic Leukaemia (CLL). Available from: https://www.leukaemiacare.org.uk/support-and-information/information-about-blood-cancer/blood-cancer-information/leukaemia/chronic-lymphocytic-leukaemia/ [Accessed: May 2022].

[10].   Eichhorst B, Robak T, Montserrat E, et al. on behalf of the European Society for Medical Oncology (ESMO) Guidelines Committee. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26 Suppl 5:v78–v84.