Lilly's Retevmo Achieves Breakthrough in Lung Cancer Trial

Lilly and Company has announced that its Phase 3 LIBRETTO-432 trial of Retevmo (selpercatinib) in early-stage lung cancer has successfully met its primary endpoint.

The trial, which evaluated selpercatinib as adjuvant therapy in RET fusion-positive non-small cell lung cancer (NSCLC), demonstrated a “highly statistically significant” improvement in event-free survival (EFS) for patients with stage II–IIIA disease. This marks a major step forward in treating early-stage lung cancer.

The study showed promising results, with EFS showing meaningful improvement for RET fusion-positive NSCLC patients. Though overall survival data is still early, the trends are favorable for selpercatinib.

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The drug’s safety profile remained consistent with previous studies, with no unexpected concerns. Detailed findings will be presented at an upcoming medical congress and submitted for peer review.

“We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey,” said Jacob Van Naarden, executive vice president of Lilly Oncology.

The LIBRETTO-432 trial is the first of its kind to evaluate a selective RET kinase inhibitor in early-stage lung cancer. NSCLC accounts for 85% of lung cancer cases in the U.S., with RET fusions present in 1–2% of these cases. The trial enrolled 151 patients who were randomized to receive either selpercatinib or a placebo post-surgery or radiotherapy.