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Alectinib shows promise in early-stage ALK-positive non-small cell lung cancer

8th September 2023

The use of adjunctive alectinib reduced disease recurrence in the early setting for people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) compared to platinum-based chemotherapy, its manufacturer Roche has announced.

Alectinib (brand name Alecensa) is the first and only ALK inhibitor to show a reduction in the risk of disease recurrence or death for people with early-stage ALK-positive NSCLC in a Phase 3 trial.

A statistically significant and clinically meaningful improvement in disease-free survival (DFS) – the study’s primary endpoint – was found when alectinib was used as adjuvant therapy in patients with completely resected stage IB to IIIA, ALK-positive NSCLC.

Around 80-85% of lung cancers are due to NSCLC, and 4-5% of patients with NSCLC are ALK-positive. Despite adjuvant chemotherapy, roughly half of all patients with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery.

Alectinib and the ALINA trial

The ALINA study is a Phase 3, randomised, active-controlled, multi-centre, open-label study evaluating the efficacy and safety of adjuvant alectinib compared to platinum-based chemotherapy in 257 patients.

The primary endpoint is DFS and secondary outcome measures include overall survival (OS) and the percentage of patients with adverse events. The OS data were immature at the time of the interim analysis. However, there have been no unexpected safety findings observed.

The findings from ALINA will be presented at an upcoming medical meeting and submitted to health authorities globally, including the US Food and Drug Administration and the European Medicines Agency.

Commenting on the interim analysis of alectinib, Levi Garraway, Roche’s chief medical officer and head of global product development, said: ‘Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need.

‘If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Roche. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.‘