SMC accepts Takeda’s ALUNBRIG▼(brigatinib) and ADCETRIS▼(brentuximab vedotin) for use in NHS Scotland for two rare cancers

SMC accepts Takeda’s ALUNBRIG▼(brigatinib) and ADCETRIS▼(brentuximab vedotin)

for use in NHS Scotland for two rare cancers

• The Scottish Medicines Consortium (SMC) has accepted ALUNBRIG▼(brigatinib), within its marketing authorisation, as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor¹

• ALK-positive aNSCLC is a rare type of lung cancer that mainly affects younger non-smokers; it is caused by a defective gene that produces an abnormal ALK protein which stimulates cells to grow and spread uncontrollably²

• The SMC has also accepted ADCETRIS▼ (brentuximab vedotin) in combination with cyclophosphamide, doxorubicin and prednisone (CHP), for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL)³

• sALCL is part of a group of rare and clinically aggressive non-Hodgkin lymphomas (NHL) known as peripheral T-cell lymphomas (PTCL) ^4,5,6

LONDON, UK, 18^th January 2021 – Takeda UK Ltd. is pleased to announce that the Scottish Medicines Consortium (SMC) has accepted two Takeda cancer medicines for use in NHS Scotland:

• ALUNBRIG (brigatinib) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor.¹
• ADCETRIS (brentuximab vedotin) in combination with cyclophosphamide, doxorubicin and prednisone (CHP), for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).³

These decisions mean eligible patients in Scotland will now have access to these treatments in line with eligible patients in England, Wales and Northern Ireland.

Brigatinib

ALK-positive aNSCLC is a rare and resistant disease which mainly affects younger people and non-smokers (median age 52 years vs. 70 years in the total lung cancer population).² Whilst the availability of ALK inhibitors has improved outcomes for these patients in recent years, some patients still progress within two to three years of starting treatment and in up to 75% the cancer will spread to the brain over the course of their disease.^7,8,9  This decision means that eligible NHS patients in Scotland will now have access to brigatinib, a next-generation ALK inhibitor that has demonstrated efficacy against the cancer in the lungs as well as against secondary cancer in the brain, as their first ALK inhibitor treatment. Brigatinib has also demonstrated a generally manageable side effect profile.¹⁰

Debra Montague, Chair of ALK Positive UK commented: “This is a wonderful outcome for ALK-positive lung cancer patients in Scotland as it brings access to brigatinib in line with the rest of the UK. Having an additional treatment option that can offer protection from disease progression in the lungs and the brain is a step forward in maintaining a good quality of life for patients, that are often in the prime of their lives.”

Professor Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust commented: “We have seen good progress in improving the quality of life for patients with ALK-positive NSCLC in recent years and today’s announcement from the SMC represents another key milestone for Scottish patients. Advanced ALK-positive lung cancer is aggressive; brigatinib has shown superiority over crizotinib in this setting, so I am thrilled we can now extend its use as a frontline ALK inhibitor.”

Brentuximab vedotin

Adult patients in Scotland with systemic anaplastic large cell lymphoma (sALCL), a rare and clinically aggressive type of blood cancer,^4,5,6 will also have access to an additional treatment option following the positive news from the SMC.³

The current standard of care in Scotland for newly diagnosed sALCL, multi-agent chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)),^4,11,12  is generally associated with poor outcomes, with many patients failing to achieve long-term survival.⁶  The availability of brentuximab vedotin, in combination with CHP, in NHS Scotland will offer eligible patients an innovative, targeted therapy that has demonstrated significantly improved progression free survival compared to standard multi-agent chemotherapy alone; with safety consistent with the established safety profile for brentuximab vedotin.^13,14

Stephen Scowcroft, Director of Operations and External Affairs, Lymphoma Action said: “Being diagnosed with sALCL can have a significant impact on the quality of life of patients and their family or friends. The disease and the current treatment options can have a physical as well as a psychological impact. We are really pleased that newly diagnosed patients can now have access to an effective treatment, that can improve their quality of life and outcomes.”

Tim Illidge, Professor of Targeted Therapy and Oncology at The Christie NHS Foundation Trust said: “The outcomes for patients diagnosed with sALCL have historically been very poor, with patients at significant risk of rapid relapse. The data for brentuximab vedotin plus CHP in untreated sALCL is practice changing and provides new hope for patients fighting this aggressive disease.”

Both positive decisions from the SMC were based on the Phase 3 trial results for brigatinib and bretuximab vedotin in the relevant indications being assessed:

Brigatinib:

• Phase 3 ALTA-1L trial, evaluating the safety and efficacy of brigatinib compared to crizotinib in adult patients with ALK-positive locally advanced or metastatic NSCLC, who have not received prior treatment with an ALK inhibitor. After more than two years of follow-up, results from the ALTA-1L trial showed that brigatinib:¹⁰

• Halved the risk of disease progression or death versus crizotinib (hazard ratio [HR] = 0.49; P<0.0001), with a 24-month median progression-free survival (mPFS) as assessed by a blinded independent review committee (BIRC) versus 11 months for crizotinib
• Achieved a two thirds reduction in the risk of intracranial disease progression or death in patients with any brain metastases at baseline (BIRC-assessed intracranial mPFS of 24.0 months with brigatinib versus 5.6 months with crizotinib (HR= 0.31; P<0.0001))
• Has a safety profile generally consistent with the existing summary of product characteristics (SmPC)

Brentuximab vedotin:

• Phase 3 ECHELON-2 trial, evaluating the safety and efficacy of brentuximab vedotin in combination with CHP compared to the current standard CHOP chemotherapy, in patients with CD30+ PTCL. sALCL is a type of PTCL and 70% of patients included in the ECHELON-2 study had sALCL.13 In patients with sALCL, brentuximab vedotin plus CHP demonstrated:

• A 41% reduction in the risk of progression event and a 46% reduction in the risk of death versus CHOP (HR=0.59; p-value=0.0031 and HR=0.54; p=0.0096, respectively, as assessed by BIRC)¹⁴
• A comparable safety profile to CHOP, with a similar incidence of peripheral neuropathy (52% vs. 55%) and febrile neutropenia (18% vs. 15%) (whole patient population)

Emma Roffe, Oncology Country Head – UK & Ireland, Takeda UK Ltd. said “We are delighted the SMC has accepted the use of brigatinib and brentuximab vedotin in their respective frontline settings. Both therapies are supported by strong efficacy and safety data and offer real benefits to patients fighting these rare and aggressive cancers. This is another example of Takeda’s continued commitment to working with health technology bodies, the NHS and patient and clinical communities in broadening access to our innovative therapies.”

CONTACT

Media in UK

Danielle Smith

T: +44 7796 714 210

danielle.smith@takeda.com