Roche's Alecensa approved in EU for early-stage ALK-positive lung cancer

Roche's Alecensa (alectinib) has recently gained approval in the European Union (EU) as an adjuvant treatment for adults with ALK-positive non-small-cell lung cancer (NSCLC) who are at high risk of recurrence following tumor resection. This approval follows a similar clearance in the United States, both based on results from the Phase III ALINA study. Levi Garraway, Roche's chief medical officer, highlighted the significance of this "landmark" approval, noting it is the first time that individuals in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor.

The ALINA study, which was central to both the EU and US approvals, was discussed at the European Society of Medical Oncology (ESMO) congress last year. Oncologists surveyed by FirstWord following the presentation of the ALINA study data expressed strong anticipation for Alecensa's use in this setting. According to the survey, 93% of physicians indicated their willingness to prescribe Alecensa as an adjuvant treatment for ALK-positive NSCLC upon its approval.

The ALINA trial's results were compelling. Alecensa showed a 76% reduction in the risk of disease recurrence or death in patients with completely resected Stage IB to IIIA ALK-positive NSCLC, compared to those receiving platinum-based chemotherapy. Additionally, further analysis revealed an improvement in central nervous system (CNS) disease-free survival. Patients with ALK-positive NSCLC are at a heightened risk of developing brain metastases compared to those with other lung cancer types.

Alecensa was originally developed by Chugai and has already been approved in over 100 countries as both a first- and second-line treatment for ALK-positive metastatic NSCLC. The drug's expansion into the adjuvant treatment space for early-stage ALK-positive NSCLC marks a significant advancement in lung cancer therapy, providing new hope for patients undergoing surgical resection and aiming to avoid cancer recurrence.