NICE recommends Roche's Alecensa for ALK-positive lung cancer

Roche’s Alecensa (alectinib) has been endorsed by the National Institute of Health and Care Excellence (NICE) as the first targeted therapy aimed at reducing the risk of recurrence for anaplastic lymphoma kinase (ALK)-positive lung cancer following complete tumor resection. This recommendation specifically applies to adult patients with stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC).

Lung cancer ranks as the third most prevalent cancer in the UK, with non-small cell lung cancer (NSCLC) constituting about 90% of these cases. ALK-positive NSCLC is particularly aggressive and often affects younger individuals with little to no history of smoking. In England, just under 100 individuals will qualify for Alecensa treatment, which is administered orally twice daily and targets the ALK gene.

NICE’s recommendation is based on promising outcomes from the ALINA study, a late-stage clinical trial. Results from this study demonstrated that Alecensa reduced the risk of disease recurrence or death by 76% compared to standard platinum-based chemotherapy in patients with completely resected stage 1B to 3A ALK-positive NSCLC. Furthermore, Alecensa showed a significant delay in central nervous system recurrence or death when compared with chemotherapy, and it was generally well-tolerated with manageable side effects.

Ouali Omani, the UK lead for lung cancer at Roche Products, emphasized the aggressive nature of ALK-positive NSCLC and the high risk of disease recurrence despite current treatments. He highlighted a significant unmet need for effective treatments for these patients.

This recommendation follows Alecensa's approval by the European Commission as an adjuvant treatment for ALK-positive NSCLC patients, granted four months ago. Levi Garraway, Roche’s chief medical officer and head of global product development, referred to the European approval as a “landmark” for individuals who have historically faced a high risk of cancer recurrence after surgery.

Additionally, the US Food and Drug Administration (FDA) has recently approved Alecensa as an adjuvant treatment for patients with ALK-positive NSCLC following tumor resection, contingent upon detection using an FDA-approved test.