On December 11, 2020 Takeda reported that Alunbrig (brigatinib) has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) (Press release, Takeda, DEC 11, 2020, View Source [SID1234572651]).

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Although ALK-positive NSCLC is rare, it is a particularly resistant disease which mainly affects younger people and non-smokers.

Although a number of ALK inhibitors have recently been introduced to this therapy area in recent years, some patients still progress within two to three years of starting treatment. In addition, up to 75% of patients develop brain metastases during the course of their disease.

Alunbrig has demonstrated efficacy against cancer both in the lungs and secondary cancer in the brain, and is administered as a single tablet taken once daily.

The NICE recommendation is based on results from the phase III ATLA-1L trial, which evaluated Alunbrig to Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) in ALK-positive locally advanced or metastatic NSCLC patients who had not previously been treated with an ALK inhibitor.

Results from this trial found that Alunbrig halved the risk of disease progression or death versus Xalkori, with a 24-month median progression-free survival rate.

Takeda’s therapy also showed a two thirds reduction in the risk of intracranial disease progression or death in patients with any brain metastases at baseline.

The most common side effects associated with Alunbrig in the ATLA-1L trial included diarrhoea, increased blood creatine phosphokinase (CPK), cough, hypertension, nausea and increased aspartate aminotransferase (AST).

"We are delighted that NICE has recommended Alunbrig as a first-line ALK inhibitor for ALK-positive advanced NSCLC. The clinical evidence supporting the value of Alunbrig 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," said Emma Roffe, oncology country head, UK & Ireland, Takeda UK.

"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," she added.