Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer

ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecensa ® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). 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.Overall survival (OS) data were immature at the time of this analysis. No unexpected safety findings were observed. Results from the ALINA study will be presented at an upcoming medical meeting and submitted to health authorities globally, including...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news