Patients with early-stage ALK-positive non-small cell lung cancer (NSCLC) could have another treatment option available soon after Alecensa met the primary endpoint of disease-free survival (DFS) in a Phase III trial.

Genentech, a member of the Roche Group, announced that the primary endpoint was met in the Phase III ALINA study (NCT03456076) at a prespecified interim analysis.

The randomised, active-controlled, multicentre, open-label study involving 257 patients evaluated the efficacy and safety of adjuvant Alecensa compared with platinum-based chemotherapy in people with resected stage Ib to IIIa ALK-positive NSCLC.

Secondary outcome measures include overall survival (OS) and the percentage of patients with adverse events. Genentech added that OS data is not yet available.

Roche’s chief medical officer and head of global product development Dr Levi Garraway 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 Genentech. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.”

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Results of the Phase III study

Also known as alectinib, Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage Ib to IIIa ALK-positive NSCLC. There were no unexpected safety findings observed in the study.

Results from the ALINA study will be presented at an upcoming medical meeting and submitted to health authorities globally, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The drug was approved for use in December 2015 by the FDA for patients with late-stage ALK-positive NSCLC. In June 2022, Roche terminated a Phase II trial of the drug in solid tumours, with stating that the primary endpoint was negative in a preliminary analysis.

Side effects may cause dose-lowering or stop treatment

A number of side effects can be seen during treatment with Alecensa which may lead a doctor to lower the dose or stop treatment.

These side effects include liver problems such as hepatotoxicity, lung problems, kidney problems, slow heartbeat, known as bradycardia, muscle pain, tenderness, and weakness and breakdown of healthy red blood cells earlier than normal, known as haemolytic anaemia.

It is not yet known whether the drug is safe for children.