By VETTAPHARMA reporter, 19th February 2026: Eli Lilly and Company announced that Retevmo (selpercatinib) demonstrated a highly statistically significant and clinically meaningful improvement in reducing the risk of disease recurrence or death in patients with early-stage RET fusion-positive non-small cell lung cancer (NSCLC). The results come from the global Phase 3 LIBRETTO-432 trial, reinforcing the critical role of genomic testing at diagnosis and across all stages of disease. The findings also build on previous positive outcomes for selpercatinib in advanced NSCLC, further validating its benefit across the treatment continuum.
The LIBRETTO-432 trial was a randomized, double-blind, placebo-controlled Phase 3 study evaluating selpercatinib as adjuvant therapy in patients with stage IB–IIIA RET fusion-positive NSCLC following definitive surgery, with or without prior chemotherapy or radiotherapy. A total of approximately 150 patients were randomized in a 1:1 ratio to receive either selpercatinib or placebo.
The study met its primary endpoint of event-free survival (EFS), showing a statistically significant and clinically meaningful improvement compared with placebo. Event-free survival measures the time from randomization to disease recurrence, progression, or death. While detailed hazard ratios and median EFS data have not yet been publicly disclosed, the company reported that the magnitude of benefit was substantial and clinically important.
Secondary endpoints include overall survival (OS), EFS assessed by blinded independent central review (BICR), and time to distant recurrence, including central nervous system (CNS) metastases. Overall survival data remain immature at this interim analysis.
Selpercatinib is an oral, highly selective RET kinase inhibitor currently approved in multiple countries for the treatment of advanced or metastatic RET fusion-positive NSCLC and certain thyroid cancers. Earlier Phase 3 trials in advanced NSCLC demonstrated significant improvements in progression-free survival compared with standard therapies. The LIBRETTO-432 findings extend these benefits into the earlier, potentially curative setting.
RET fusions occur in approximately 1–2% of NSCLC cases, underscoring the importance of comprehensive genomic testing at diagnosis. Experts emphasize that early identification of actionable mutations such as RET fusions allows patients to receive targeted therapies that may significantly reduce recurrence risk and improve long-term outcomes.
Detailed data from LIBRETTO-432 are expected to be presented at an upcoming medical congress and submitted for regulatory review.
Source credit:
- Eli Lilly and Company. (2026, February 16). Lilly’s Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer [Press release]. Click here
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