Scottish Medicines Consortium Accepts VENCLYXTO®▼(venetoclax) Combination in Patients with the Aggressive Blood Cancer Acute Myeloid Leukaemia

Scottish Medicines Consortium Accepts VENCLYXTO®▼(venetoclax) Combination in Patients with the Aggressive Blood Cancer Acute Myeloid Leukaemia

• For the first time in Scotland, venetoclax in combination with azacitidine will be available to untreated adult patients with Acute Myeloid Leukaemia (AML) unable to receive intensive chemotherapy (IC)1
• The venetoclax combination has demonstrated the ability to offer these patients significantly improved overall survival, increased rates of rapid and durable remission and blood transfusion independence, compared with treatment with azacitidine alone2
• AML is an acute leukaemia that can cause symptoms very quickly, requiring treatment as soon as possible after diagnosis3

MAIDENHEAD, UK, 11 April 2022 – AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has accepted venetoclax in combination with azacitidine for use within NHS Scotland as an option for untreated AML in adults when intensive chemotherapy (IC) is unsuitable.1 The decision means that eligible patients in Scotland will now benefit from an oral treatment which can largely be administered at home and offers significantly improved overall survival, increased rates of rapid and durable remission and blood transfusion independence, compared with treatment using azacitidine alone.1,2

AML is an aggressive and difficult-to-treat blood cancer which if not treated, would cause death within a few weeks or months.3,4 Approximately 200 people are diagnosed with AML in Scotland every year.5 The disease predominately affects older people, with more than 4 in 10 of all new AML cases in the UK being diagnosed in people aged 75 and over.4 The past three decades have seen few advances in the treatment of AML.6 With limited treatment options, the prognosis for these patients has remained poor. Median survival is just 6–10 months, during which patients typically require hospitalisation and frequent blood transfusions impacting their quality of life.7,8

Commenting on the decision, Dominic Culligan, Consultant Haematologist and honorary senior lecturer at Aberdeen Royal Infirmary and the University of Aberdeen said: “The new treatment option of venetoclax plus azacitidine is very welcome news for patients in Scotland. It is a significant advancement in the treatment of AML for patients not suitable for intensive chemotherapy and represents a step change in therapy for this aggressive, difficult-to-treat blood cancer.”

Venetoclax is an oral, once-daily treatment that works by blocking the action of the B-cell lymphoma-2 (BCL-2) protein, the presence of which helps cancer cells survive.9 As it can be taken at home and reduces dependency on blood transfusions, treatment with venetoclax was considered by patient and clinical experts to likely mean fewer hospital visits for these clinically vulnerable patients, who are more susceptible to coronavirus and other infections.10

Zack Pemberton-Whiteley, Chief Executive of Leukaemia Care, said: ‘Advances in treatment development for this group of AML patients has been limited in the past. However, thanks to the SMC’s recommendation, there is a new, effective treatment now available to patients in Scotland. This is particularly important when considering AML is a rapidly progressing, life-threatening disease, which has a significant emotional and practical burden on patients and their loved ones’.

Belinda Byrne, Medical Director, AbbVie UK, said: ‘We are delighted that the SMC has recommended venetoclax in combination with azacitidine as there has been an urgent need for effective new treatments for AML for many years. Routine availability of this combination for patients with this aggressive blood cancer could provide them with that all important, and precious, time back with their families.’

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

+44 (0)7977 055 997

sophia.e.james@abbvie.com

Rebecca Goldberg

+44 (0)20 3900 6100

Rebecca.Goldberg@virgohealth.com

NOTES TO EDITORS:

About venetoclax

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma 2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis.9

Venetoclax in combination with a hypomethylating agent is indicated for the treatment of adult patients newly diagnosed with acute myeloid leukaemia who are ineligible for intensive chemotherapy.9 In December 2021 the National Institute for Health and Care Excellence (NICE) published a positive Final Appraisal Document recommending routine NHS use of venetoclax with azacitidine for the treatment of AML.11

VIALE-A Phase 3 trial2

The recommendation by the SMC is based on results from the Phase 3 double-blind, placebo-controlled VIALE-A trial. VIALE-A evaluated the efficacy and safety of venetoclax in combination with azacitidine in patients with newly diagnosed acute myeloid leukaemia who were ineligible for intensive chemotherapy. The study met its primary endpoint of statistically significant improvement of overall survival (OS). OS was 14.7 months for the venetoclax plus azacitidine arm (n=286) versus 9.6 months in the placebo plus azacitidine arm (n=144) (p<0.001). The study also met secondary endpoints, including but not limited to; a composite complete remission rate of 66.4% in the venetoclax plus azacitidine arm vs. 28.3% in the placebo plus azacitidine arm (p<0.001) and greater platelet and red cell transfusion independence with venetoclax plus azacitidine vs. placebo plus azacitidine (59.8% vs. 35.2% and 68.5% and 49.7%, respectively; p<0.001).

Adverse events (AEs)

In the VIALE-A trial the safety profile of venetoclax plus azacitidine was consistent with the known side effect profiles of both agents, and AEs were consistent with expectations for an older AML population. The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in combination with azacitidine were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia and decreased appetite.9 The most frequently reported serious AEs, reported in at least 5% of patients in either treatment arm were febrile neutropenia, pneumonia, sepsis and haemorrhage.9

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 people’s 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.

References

1. Scottish Medicines Consortium. Venetoclax in combination with azacitidine for treatment of untreated adult patients with Acute Myeloid Leukaemia unable to receive intensive chemotherapy. Available from: https://www.scottishmedicines.org.uk/medicines-advice/venetoclax-venclyxto-full-smc2412/ [Accessed: April 2022].
2. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. New Engl J Med 2020;383:617–629.
3. MacMillan Cancer Support. Acute Myeloid Leukaemia (AML). Available from: https://www.macmillan.org.uk/cancer-information-and-support/leukaemia/acute-myeloid-leukaemia-aml [Accessed: March 2022].
4. Cancer Research UK. About Acute Myeloid Leukaemia (AML). Available from: https://www.cancerresearchuk.org/about-cancer/acute-myeloid-leukaemia-aml/about-acute-myeloid-leukaemia [Accessed: March 2022].
5. Cancer Research UK. Acute myeloid leukaemia (AML) incidence. Available from:

https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-aml#heading-Zero [Accessed: March 2022].

1. Fiorentini A, Capelli D, Saraceni F, et al. The Time Has Come for Targeted Therapies for AML: Lights and Shadows. Oncol Ther 2020;8:13–32.
2. Oran B and Weisdorf DJ. Survival for older patients with acute myeloid leukemia: a population-based study. Haematologica 2012;97:1916–1924.
3. LeBlanc T, Seetasith A, Choi M, et al. Transfusion burden on older patients with Acute Myeloid Leukaemia receiving low intensity treatments. European Hematology Association. E-Poster (EP1739). Available from: https://library.ehaweb.org/eha/2020/eha25th/294219/thomas.william.leblanc.transfusion.burden.on.older.patients.with.acute.myeloid.html [Accessed: March 2022].
4. Venetoclax Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/32650#gref [Accessed: March 2022].
5. NHS. Complications. Acute Myeloid Leukaemia. Available from: https://www.nhs.uk/conditions/acute-myeloid-leukaemia/complications/ [Accessed: March 2022].
6. NICE Final Appraisal Document. Venetoclax with a hypomethylating agent for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable. Available from: https://www.nice.org.uk/ [Accessed: March 2022].