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Drugmaker announces ‘unprecedented’ results for ALK inhibitor in early-stage lung cancer trial
The randomized, active-controlled, multicenter, open-label ALINA trial, which includes 257 participants with completely resected stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. According to the data, the ALK inhibitor alectinib (Alecensa) demonstrated a statistically significant and clinically meaningful improvement in DFS compared with platinum-based chemotherapy. “Alecensa is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death for people with early-stage ALK-positive NSCLC in a Phase III trial,” according to the press release.
The trial's secondary outcome measures include overall survival (OS) and proportion of patients who experience adverse events. The company said that OS data were immature at the time of the interim analysis and no unexpected safety findings were observed. ALINA results will be presented at an upcoming medical meeting and submitted to FDA and European Medicines Agency (EMA).
Source:
(2023, September 1). F. Hoffman-La Roche Ltd. Roche's Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer. https://www.globenewswire.com/news-release/2023/09/01/2735774/0/en/Roche-s-Alecensa-delivers-unprecedented-Phase-III-results-for-people-with-ALK-positive-early-stage-lung-cancer.html