Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting its primary endpoint and showcasing the drug’s potential in this patient population.
Trial Results and Implications
The median DFS had not been reached for the experimental arm receiving Alecensa, while it was estimated at 41.3 months for the control group receiving chemotherapy. This substantial improvement in DFS highlights the potential of Alecensa to become a new standard of care for patients with early-stage resected ALK-positive NSCLC.
Safety and Secondary Endpoints
Although data for the secondary endpoint of overall survival (OS) are still immature, the safety and tolerability readings from the trial were consistent with previous findings. This consistency underscores the drug’s favorable profile in terms of patient safety and supports its continued investigation in the treatment of NSCLC.
Future Outlook
The positive results from this Phase III trial are a significant step forward in the development of Alecensa for early-stage NSCLC and contribute to Roche’s ongoing commitment to advancing cancer care. With these findings, Roche is poised to potentially change the treatment landscape for patients with this form of lung cancer.-Fineline Info & Tech