- LIBRETTO-432 trial shows selpercatinib improves event-free survival in early-stage RET fusion-positive NSCLC.
- Overall survival results are immature with few events observed.
- Safety profile of selpercatinib is consistent with previous trials.
- Detailed results to be presented at a future medical congress.
Study Overview
The Phase 3 LIBRETTO-432 trial evaluated Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in event-free survival (EFS).
Survival and Safety
While overall survival results favored selpercatinib, they were immature with few events observed at the time of analysis. The safety profile of selpercatinib was consistent with previous trials in its development program.
Future Presentations
Detailed results from the LIBRETTO-432 trial will be presented at an upcoming medical congress and submitted to a peer-reviewed journal for further discussion with global health authorities.
Context and Implications
NSCLC accounts for about 85% of all lung cancer diagnoses in the U.S., with around 30% of patients presenting with stage IB-IIIA disease. Approximately 50% of NSCLC patients have actionable biomarkers, with RET fusions identified in 1-2% of cases. The trial underscores the importance of genomic testing at diagnosis and across all disease stages.
