Retevmo adjuvant therapy has demonstrated a substantial event-free survival benefit in early-stage RET fusion-positive non-small cell lung cancer (NSCLC). Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 trial evaluating Retevmo (selpercatinib) versus placebo in patients with stage II–IIIA RET fusion-positive NSCLC.
The study met its primary endpoint, showing a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS). These findings position Retevmo adjuvant therapy as a potential new standard for this genetically defined patient population.
LIBRETTO-432 Phase 3 Trial Results
LIBRETTO-432 is the first and only randomized Phase 3 trial assessing a selective RET kinase inhibitor as adjuvant therapy in early-stage RET fusion-positive lung cancer. Patients enrolled had stage II–IIIA disease following definitive treatment.
In the trial, selpercatinib significantly improved event-free survival compared with placebo. Although overall survival data trended in favor of selpercatinib, the results remain immature due to a low number of events at the time of analysis.
Importantly, the safety profile observed in LIBRETTO-432 was consistent with previous studies in the selpercatinib development program. No unexpected safety signals were reported.
Importance of Early Targeted Treatment
According to Jacob Van Naarden, Executive Vice President and President of Lilly Oncology, cancer medicines often have the greatest impact when used earlier in treatment. Therefore, the strong effect size seen with Retevmo adjuvant therapy reinforces the value of targeted treatment in early-stage lung cancer.
Targeted therapies are already established in early-stage EGFR- and ALK-driven NSCLC. As a result, these new data may further encourage comprehensive genomic testing at diagnosis. Broader biomarker testing could help identify patients with RET fusions who may benefit from early intervention.
RET Fusion-Positive NSCLC Landscape
Non-small cell lung cancer accounts for approximately 85% of lung cancer diagnoses in the United States. Around 30% of patients present with stage IB–IIIA disease. Moreover, about half of NSCLC cases harbor actionable biomarkers.
RET fusions are identified in approximately 1–2% of all NSCLC cases. Although this represents a small subset, precision therapies like selpercatinib offer meaningful clinical benefit for these patients.
Next Steps for Retevmo
Detailed results from LIBRETTO-432 will be presented at an upcoming medical congress and submitted to a peer-reviewed journal. In addition, discussions with global health authorities are planned.
Overall, Retevmo adjuvant therapy marks a significant advancement for patients with early-stage RET fusion-positive NSCLC. By improving event-free survival in this setting, selpercatinib may reshape treatment strategies and reinforce the importance of molecular testing in lung cancer care.
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