Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) in patients with early-stage (II-IIIA) revised during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Overall survival results trended in favor of selpercatinib, but were immature at the time of this analysis with few events observed.
The overall safety profile of selpercatinIB in LIBRETTO-432 was generally consistent with previously reported trials in the selpercatinib development program. Det Detailed results will be presented at an upcoming medical congress, submitted to a peer-reviewed journal, and discussed with health authorities globally. LIBRETTO-432 is the first and only randomized Phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population.
NSCLC accounts for about 85% of all lung cancer diagnoses in the U.S., and around 30% of patients with NSCLC present with stage IB-IIIA disease. Approximately 50% of people with NSCLC have actionable biomarkers, and RET fusions have been identified in one to two% of all NSCLC cases. About LIBRETTO-432 is a Phase 3, global, multicenter, randomized, double-blind, controlled clinical trial of RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy, if indicated.
The trial enrolled 151 patients who were randomized 1:1 to receive either selpercatinib or placebo as adjuvant therapy for RET fusion-positive NSCL C. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (IMPORTANT SAFETY information for RET fusion-positive lung cancer). Hepatotoxicity: Serious hepatic adverse reactions occurred in 3% of patients treated with Retevmo.
Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling. No dosage modification is recommended for patients with mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] 15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation).
A recommended dosage has not been established for patients with end-stage renal disease. With each step toward a healthier world, the company're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of world and working to ensure its medicines are accessible and affordable.
