Genentech: Alecensa Reduces Risk Of Disease Recurrence/ Death In ALK-Positive Early-Stage NSCLC

Genentech, Inc., affiliated to Swiss drug major Roche Holding AG (RHHBY), announced Wednesday results from the primary analysis of the Phase III ALINA study of Alecensa (alectinib) in people with anaplastic lymphoma kinase or ALK-positive non-small cell lung cancer or NSCLC.

The trial demonstrated a statistically significant and clinically meaningful improvement in disease-free survival or DFS, which was the primary endpoint.

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer that has spread to other parts of the body and is caused by an abnormal ALK gene.

The study results showed that Alecensa reduces the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected Stage IB to IIIA ALK-positive NSCLC.

In the study, a clinically meaningful improvement of central nervous system or CNS-DFS was also observed. The safety and tolerability of Alecensa in this trial were consistent with previous trials in the metastatic setting and no unexpected safety findings were observed, the company noted.

Meanwhile, overall survival data were immature at the time of this analysis and follow-up is ongoing to report a more mature estimate.

The company is presenting the full results of ALINA as a late-breaking oral at the European Society of Medical Oncology (ESMO) Congress 2023 Presidential Symposium on Saturday, October 21.

These data will be submitted to global health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency.

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