Eli Lilly (NYSE:LLY) announced Monday that its drug Retevmo reached the primary goal of a late-stage study, significantly improving event-free survival for patients with a specific genetic form of early-stage lung cancer.
The Phase 3 trial, known as LIBRETTO-432, focused on patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors harbor a "RET" gene fusion.
Retevmo, known chemically as selpercatinib, was administered as an adjuvant therapy—meaning it was given after definitive treatments like surgery or radiation to prevent the cancer from returning.
Lilly stated the results were "highly statistically significant" and clinically meaningful, though the company did not disclose the specific numerical data.
While the trend for overall survival—a secondary goal—was favorable, the data remain "immature" as not enough deaths have occurred in the study to draw a definitive conclusion.
Retevmo is already approved for advanced and metastatic RET-positive lung and thyroid cancers.
This successful trial represents a strategic push by Lilly to move the therapy into "earlier-stage" settings, where the potential for a permanent cure is higher.
Meanwhile, the safety profile was consistent with previous Retevmo studies, which have noted side effects such as high blood pressure and liver enzyme elevations.
Lilly plans to present the full dataset at an upcoming medical congress and will begin discussions with global health regulators for expanded approval.