ESMO 2023 – Roche heralds "unprecedented" Alecensa data

Roche said in September that data from the adjuvant Alina trial were "unprecedented", and detailed results have not disappointed, an ESMO late-breaking abstract reveals. Adjuvant Alecensa reduced risk of disease recurrence or death by an impressive 76% versus platinum-based chemotherapy in operable ALK-positive NSCLC – representing a first-in-class success in this setting. In the ITT population, which included stage IB-IIIA patients, the median DFS for Alecensa was not yet reached versus 41.3 months for chemotherapy (HR=0.24; p<0.0001). The same DFS hazard ratio was achieved among patients with Stage II-IIIA disease. Additionally, Alecensa delivered a clinically meaningful improvement of CNS-DFS in the ITT population (HR=0.22). Overall survival data were immature in this analysis. Full data will be featured at an ESMO presidential symposium on Saturday, and Roche has said it plans to file Alecensa in this setting on the back of these results.