SMC APPROVES ORAL TREATMENT CALQUENCE (ACALABRUTINIB) FOR PATIENTS WITH THE MOST COMMON TYPE OF LEUKAEMIA IN SCOTLAND - CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)

smc APPROVES ORAL TREATMENT CALQUENCE    (ACALABRUTINIB) FOR PATIENTS WITH THE MOST COMMON TYPE OF LEUKAEMIA IN SCOTLAND - chronic lymphocytic leukaemia (CLL)

·         This is the first time that the Scottish Medicines Consortium (SMC) has approved access to a targeted oral monotherapy for patients with untreated, non-high risk CLL.[i]

·         Around 260 people in Scotland are diagnosed with CLL every year and significant unmet treatment needs remain.[ii]

·         In clinical trials, acalabrutinib significantly prolonged the time that both untreated and previously treated patients spent in remission (time to disease progression or death) compared with existing treatment options, whilst being generally well-tolerated.[iii]^,[iv]

Luton, UK, 07 June 2021 – AstraZeneca has today announced that its oral targeted cancer therapy Calquence (acalabrutinib) is now available for use within NHS Scotland as a treatment for chronic lymphocytic leukaemia (CLL).^1,[v]^,[vi]

Today, the Scottish Medicines Consortium (SMC) has accepted acalabrutinib for restricted use within NHS Scotland as monotherapy for the treatment of adult patients with previously untreated CLL without a del(17p) or TP53 mutation and who are ineligible for fludarabine, cyclophosphamide and rituximab (FCR) therapy.¹

This is the first time that the SMC has approved access to targeted oral monotherapy with a BTK inhibitor for this group of patients. Previously, standard therapy for those receiving treatment for CLL for the first time consisted of combination therapy involving intravenous administration in hospital. Other patients with CLL in Scotland have had access to BTK inhibitor therapy since 2016.[vii]^,[viii]

This decision builds on SMC guidance published in April 2021, which accepted acalabrutinib, a second generation BTK inhibitor, for restricted use as monotherapy for the treatment of adult patients with:

• previously untreated CLL who have particular genetic characteristics -  a 17p deletion or TP53 mutation - and in whom chemo-immunotherapy is unsuitable;⁶ and
• relapsed/refractory CLL who have had at least one previous therapy, in whom chemo-immunotherapy is unsuitable.⁷

Commenting on today’s announcement, Dr Mark Rafferty, Consultant Haematologist at the Beatson West of Scotland Cancer Centre, said: “The availability of acalabrutinib through NHS Scotland has the potential to improve disease outcomes for many patients with CLL. The need for effective, targeted treatments that can be taken at home is quite significant, particularly for those who are receiving therapy for the first time. Acalabrutinib is generally well-tolerated and today’s announcement is exciting and hopeful news for the CLL community.”

The SMC advice for acalabrutinib is based on positive results from two Phase III clinical trials: ELEVATE-TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that acalabrutinib significantly reduced the relative risk of disease progression versus the comparator arms in both first-line (treatment naïve) and previously treated CLL. Across both trials, acalabrutinib was generally well-tolerated.3^,4

CLL is the most common type of leukaemia in adults in Scotland, and the UK, and men are nearly twice as likely to develop CLL as women.[ix]^,[x]^,[xi]  It is estimated that around 1,000 people are currently living with CLL in Scotland, 41% of whom are aged 75 and over.11

Commenting on what today’s decision means for the patient community, John Greensmyth, Trustee, CLL Support, said: “CLL is an incurable blood cancer affecting hundreds of people across Scotland – patients who until a few years ago could only be treated with standard chemotherapy, which can be hard to tolerate. The availability of targeted oral drugs has expanded treatments options to CLL patients and with today’s announcement, many people will be able to access to a BTK inhibitor for the first time. This is a very welcome advance in disease management and I hope to see progress continue in the field of CLL and other blood cancers.”

Tom Keith-Roach, President, AstraZeneca UK, said: “Today’s SMC decision is welcome news for people living with CLL who, like many others who have been shielding during the pandemic, have had a very tough year. Effective, well-tolerated, oral treatments like acalabrutinib have an important role to play in getting our health service and patient outcomes back on track and we are delighted that this particular group of patients in Scotland now have this option.”

Arun Krishna, Head of Oncology at AstraZeneca UK, said: “Today’s positive advice from the SMC means, for the first time, that all patients across the UK with previously untreated non-high risk CLL now have access to acalabrutinib. Until recently, standard treatment for many CLL patients was chemo-immunotherapy that is administered in hospital. This decision gives patients access to an effective treatment they can take at home.”

He added: “Our aim at AstraZeneca is to ensure that those working in cancer care have what they need to catalyse changes in the practice of medicine to improve patient experiences, and achieving NHS access to our medicines is critical for delivering this in the UK.”

Acalabrutinib was licensed for use in Europe and the UK in November 2020 as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL; and as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.[xii]

Further information about the clinical trial data evaluating the efficacy and safety profile of acalabrutinib is provided below, and a full summary of product characteristics can be found here: https://www.medicines.org.uk/emc/product/11917/smpc.

[i] Scottish Medicines Consortium. 2021. Acalabrutinib (Calquence). Available at: https://www.scottishmedicines.org.uk/medicines-advice/acalabrutinib-calquence-abb-smc2347 [Accessed June 2021].

[ii] Public Health Scotland. Cancer statistics: Leukaemias: chronic lymphocytic leukaemia: Annual incidence. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Publications/2019-04-30/i_cancer_leukaemias.xls [Accessed June 2021].

[iii] Ghia P, et al. (2020). ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia [published online ahead of print, 2020 May 27]. J Clin Oncol. 1;38(25), pp.2849-2861.

[iv] Sharman JP, et al. (2019). ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 134(Supplement_1): 31.

[v] Scottish Medicines Consortium. 2021. acalabrutinib (Calquence). Available at: https://www.scottishmedicines.org.uk/medicines-advice/acalabrutinib-calquence-abb-smc2346/ [Accessed June 2021].

[vi] Scottish Medicines Consortium. 2021. acalabrutinib (Calquence). Available at: https://www.scottishmedicines.org.uk/medicines-advice/acalabrutinib-calquence-abb-smc2348/ [Accessed June 2021].

[vii] Scottish Medicines Consortium. 2021. ibutinib (Imbruvica). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ibrutinib-imbruvica-cll-fullsubmission-115116/ [Accessed June 2021].

[viii] Scottish Medicines Consortium. 2021. ibutinib (Imbruvica). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ibrutinib-imbruvica-resubmission-115116/ [Accessed June 2021].

[ix] Cancer Research UK. About Chronic Lymphocytic Leukaemia. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/about#:~:text=Around%203%2C800%20people%20are%20diagnosed,to%20develop%20CLL%20than%20women [Accessed June 2021]

[x] Lymphoma-Action.org. Chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). Available at: https://lymphoma-action.org.uk/types-lymphoma/chronic-lymphocytic-leukaemia-cll-and-small-lymphocytic-lymphoma-sll#:~:text=Around%203%2C500%20to%204%2C000%20people,is%20rare%20in%20young%20people [Accessed June 2021].

[xi] Public Health Scotland. Cancer statistics: Leukaemias: chronic lymphocytic leukaemia: Five year summary of incidence. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Publications/2019-04-30/si_cancer_leukaemias.xls [Accessed June 2021].

[xii] Calquence 100 mg hard capsules [prescribing information]. Available at: https://www.medicines.org.uk/emc/product/11917/smpc [Accessed June 2021]