Roche Announces Positive Phase III ALINA Trial of Alecensa in Early-Stage ALK-Positive NSCLC, Submitting Regulatory Filings

On September 1, Roche announced that the Phase III ALINA study of alectinib in treating ALK-positive early-stage non-small cell lung cancer (NSCLC) met its primary endpoint of disease-free survival (DFS) in a pre-planned interim analysis. Alectinib is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death in patients with ALK-positive early-stage NSCLC in a Phase III trial.

Results showed that, compared with platinum-based chemotherapy, adjuvant treatment with Alectinib in patients with completely resected IB (tumor ≥4cm) to IIIA stage ALK-positive NSCLC can reduce the risk of disease recurrence and death.

At the time of this analysis, the overall survival (OS) data were not yet mature. No unexpected safety findings were observed. The results of the ALINA study will be presented at an upcoming medical conference and submitted to global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"Alectinib has transformed treatment outcomes for patients with advanced ALK-positive NSCLC, and now, for the first time, these compelling results demonstrate that this drug can also play a critical role in earlier-stage disease, where significant unmet needs remain," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. "If approved for this use, alectinib has the potential to treat cancer before it spreads, thereby increasing the chances of a cure, which is our ultimate goal at Roche. We look forward to sharing these data with regulatory authorities in the hope of bringing this benefit to patients as soon as possible."

Currently, about half of the patients with early-stage lung cancer (45%-76%, depending on the stage of the disease) will experience cancer recurrence after surgery despite receiving adjuvant chemotherapy. Recent innovative therapies (including immunotherapy) have improved the prognostic outlook for some patients with early-stage NSCLC; however, there are currently no ALK inhibitors approved for early-stage ALK-positive disease. Approximately 5% of NSCLC patients are ALK-positive.

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