ALUNBRIG▼(brigatinib) now available on the NHS in England, Wales and Northern Ireland for adults with ALK-positive advanced non-small cell lung cancer who have not been previously treated with an ALK inhibitor

• Takeda UK Ltd. is pleased to announce that NICE has recommended ALUNBRIG▼(brigatinib) as a treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor, within a final appraisal document (FAD) published today¹
• ALK-positive NSCLC is a rare type of lung cancer that mainly affects younger people and non-smokers; it is caused by a defective gene that produces an abnormal ALK protein which stimulates cells to grow and spread uncontrollably²
• Some ALK-positive advanced NSCLC patients still progress within two to three years of commencing treatment, with up to 75% developing secondary cancer in the brain during their disease; this highlights a need for further treatment options like brigatinib^3,4,5
• Long-term results from the Phase III ALTA-1L trial showed brigatinib provided superior efficacy compared to crizotinib; and delivered a sustained and significantly longer duration of improvement in quality of life with a generally manageable tolerability profile⁶

LONDON, UK, 10th December 2020 – Takeda UK Ltd. is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended ALUNBRIG (brigatinib) as a treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor, within a final appraisal document (FAD) published today.¹  This positive recommendation has resulted from close collaborative working between Takeda, NICE, NHS England, the clinical and patient community, and means that eligible patients in England, Wales and Northern Ireland will now have access to brigatinib. 

ALK-positive NSCLC 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 over recent years has significantly improved outcomes in ALK-positive advanced NSCLC, some patients still progress within two to three years of starting treatment and up to 75% develop brain metastases over the course of their disease.^3,4,5 This emphasises the importance of early and effective disease control to help delay disease progression, protect brain function and reduce disease symptoms to maintain or improve a patient’s quality of life.⁷

Debra Montague, Chair of ALK Positive UK commented on the NICE recommendation for brigatinib: “This is fantastic news for patients; not only does it increase our treatment options, but it also provides reassurance to patients that their brains are being protected. As an ALK-positive patient myself, I know the fear of treatment failure and progression in the brain every time I visit the hospital for a scan. It is hard enough for people in the prime of their lives to deal with an ALK-positive lung cancer diagnosis; but imagine being told that there is potential for disease to progress to your brain that could impact your prognosis and ability to live a normal life. Treatments like brigatinib are vital to keeping patients alive for as long as possible, with a good quality of life, so it is so important that it is now available on the NHS.”

Brigatinib is a next-generation ALK inhibitor that will provide eligible patients with a targeted therapy that has demonstrated efficacy against cancer in the lungs and secondary cancer in the brain and has a generally manageable side effect profile.⁶ It also offers patients a convenient dosing schedule, as it consists of a single tablet taken once daily either with or without food.^8,9,10,11  

Professor Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust commented: “The advancements in ALK-positive NSCLC over the last few years have made a significant impact to patient quality of life and duration of survival. However, due to the aggressive nature of advanced disease, there remains a clear need for additional, effective treatment options, from diagnosis, that extend survival and protect the brain. As brigatinib has shown superiority compared to crizotinib in this setting, this positive news from NICE is an important advancement for patients and gives physicians another option in our front-line arsenal to fight this disease.”

The NICE recommendation is based on results from the Phase III 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 brigatinib demonstrated superiority over crizotinib, with significant anti-tumour activity observed, especially in patients with baseline brain metastases. In this trial brigatinib:⁶

• 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
• Showed 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))
• Delivered a sustained and significantly longer duration of improvement in quality of life versus crizotinib (median duration of improvement in GHS/QOL* not reached with brigatinib versus 12 months for crizotinib (HR=0.27; P<0.0001))

The safety profile of brigatinib in the ALTA-1L trial was generally consistent with the existing European summary of product characteristics (SmPC). The most common adverse events of any grade included diarrhoea, increased blood creatine phosphokinase (CPK), cough, hypertension, nausea and increased aspartate aminotransferase (AST).⁶

Emma Roffe, Oncology Country Head – UK & Ireland, Takeda UK Ltd. said: “We are delighted that NICE has recommended brigatinib as a first-line ALK inhibitor for ALK-positive advanced NSCLC. The clinical evidence supporting the value of brigatinib is compelling; and having it available at the initial stage of treatment for advanced disease gives physicians broader options to ensure optimum quality of life and survival for patients. At Takeda, we are proud of our ongoing commitment to ensuring patients have access to innovative therapies, through our effective partnerships with NICE, NHS England and clinical and patient communities.”