Eli Lilly and Company (NYSE:LLY) announced positive topline results from its Phase 3 LIBRETTO‑432 trial, evaluating Retevmo (selpercatinib) as adjuvant therapy in patients with early‑stage 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 compared to placebo.
Trial highlights
Overall survival results trended in favor of Retevmo, though data remain immature with few events observed. The safety profile was consistent with earlier studies in the selpercatinib program. Detailed findings will be presented at an upcoming medical congress and submitted to a peer‑reviewed journal.
Clinical significance
Jacob Van Naarden, president of Lilly Oncology, noted that targeted therapies often deliver their greatest impact when administered early. The LIBRETTO‑432 results align with data seen in EGFR‑ and ALK‑driven lung cancers, reinforcing the importance of genomic testing at diagnosis and across all stages of disease.
About the trial
LIBRETTO‑432 is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this setting. The trial enrolled 151 patients with stage II‑IIIA RET fusion‑positive NSCLC, randomized to receive either selpercatinib or placebo following surgery or radiotherapy. The primary endpoint was investigator‑assessed event‑free survival, with secondary endpoints including overall survival, CNS recurrence, and safety.
About Retevmo
Retevmo (selpercatinib) is a selective RET kinase inhibitor with central nervous system activity. It is FDA‑approved for adult patients with locally advanced or metastatic NSCLC harboring RET gene fusions, as detected by an FDA‑approved test. The medicine is taken orally twice daily, with dosing based on patient weight. Safety information includes risks of hepatotoxicity, interstitial lung disease, hypertension, QT prolongation, hemorrhage, hypersensitivity, and other adverse events, requiring careful monitoring during treatment.
About Lilly
Founded nearly 150 years ago, Lilly is a global medicine company focused on turning science into healing. Its portfolio spans diabetes, obesity, Alzheimer’s disease, immune disorders, and oncology. Lilly continues to advance biotechnology and genetic medicine, aiming to make life better for millions worldwide.
