Lilly's Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer

Core Insights - Eli Lilly's Retevmo (selpercatinib) shows significant event-free survival benefits as an adjuvant therapy for early-stage RET fusion-positive lung cancer, meeting its primary endpoint in the Phase 3 LIBRETTO-432 trial [1] - The trial demonstrated a statistically significant improvement in event-free survival (EFS) compared to placebo, although overall survival results were still immature at the time of analysis [1] - The study reinforces the importance of genomic testing for patients diagnosed with early-stage lung cancer [1] Group 1: Clinical Trial Results - LIBRETTO-432 is the first randomized Phase 3 study evaluating a selective RET kinase inhibitor as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer (NSCLC) [1] - The trial enrolled 151 patients, randomized 1:1 to receive either selpercatinib or placebo, with the primary endpoint being EFS assessed by investigators [1] - Secondary endpoints included overall survival, EFS assessed by blinded independent central review, and time to distant disease recurrence [1] Group 2: Patient Demographics and Disease Context - NSCLC accounts for approximately 85% of all lung cancer diagnoses in the U.S., with around 30% of patients presenting with stage IB-IIIA disease [1] - About 50% of NSCLC patients have actionable biomarkers, with RET fusions identified in 1-2% of all NSCLC cases [1] Group 3: Safety Profile - The overall safety profile of selpercatinib in LIBRETTO-432 was consistent with previous trials, with serious hepatic adverse reactions occurring in 3% of patients [2] - Increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were observed in 59% and 55% of patients, respectively [2] - Hypertension occurred in 41% of patients, with Grade 3 hypertension in 20% [2] Group 4: Future Directions - Detailed results from the LIBRETTO-432 trial will be presented at an upcoming medical congress and submitted for peer review [1] - The company aims to accelerate the use of genomic testing for all patients diagnosed with early-stage lung cancer based on these findings [1]