Eli Lilly and Company has announced positive topline results from its Phase 3 LIBRETTO-432 trial evaluating Retevmo(selpercatinib) as an adjuvant therapy in patients with early-stage RET fusion-positive non-small cell lung cancer (NSCLC).
The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) compared with placebo in patients with stage II to IIIA disease. Event-free survival measures the length of time after treatment during which a patient remains free from cancer recurrence or death.
Overall survival data showed a trend in favor of selpercatinib; however, the data remain immature due to a limited number of events at the time of analysis. The safety profile observed in the trial was generally consistent with previous studies in the selpercatinib clinical development program.
The LIBRETTO-432 trial is the first randomized Phase 3 study to assess a selective RET kinase inhibitor as adjuvant therapy in this patient population. Adjuvant therapy refers to treatment given after surgery to reduce the risk of cancer recurrence.
The findings build on earlier clinical data supporting selpercatinib in advanced RET-altered NSCLC and reinforce the importance of genomic testing at diagnosis and across all stages of lung cancer. Targeted therapies directed at specific genetic drivers have increasingly reshaped the treatment landscape in early-stage disease, particularly in patients with EGFR- and ALK-driven tumors.
NSCLC accounts for approximately 85 percent of all lung cancer diagnoses in the United States. Around 30 percent of patients are diagnosed at stage IB to IIIA, where curative-intent treatment is possible but the risk of recurrence remains significant. Roughly half of NSCLC cases harbor actionable biomarkers, while RET fusions are identified in an estimated one to two percent of cases.
Detailed results from LIBRETTO-432 are expected to be presented at an upcoming medical congress, submitted for publication in a peer-reviewed journal, and discussed with regulatory authorities worldwide.
