Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer – Eli Lilly
Eli Lilly and Company announced positive topline results from the Phase III 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) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). LIBRETTO-432 is the first and only randomized Phase III study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population.
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. Detailed results will be presented at an upcoming medical congress, submitted to a peer-reviewed journal, and discussed with health authorities globally.
“We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient’s treatment journey. The LIBRETTO-432 results support this observation, demonstrating an effect size in line with the most striking data for targeted adjuvant therapy in lung cancer,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “Building on the adoption of targeted therapies for early-stage patients with EGFR- and ALK-driven lung cancer, we hope these results further accelerate the use of genomic testing for all people diagnosed with early-stage disease.”
NSCLC accounts for about 85 percent of all lung cancer diagnoses in the U.S., and around 30 percent of patients with NSCLC present with stage IB-IIIA disease. Approximately 50 percent of people with NSCLC have actionable biomarkers, and RET fusions have been identified in one to two percent of all NSCLC cases.
About LIBRETTO-432
LIBRETTO-432 is a Phase III, global, multicenter, randomized, double-blind, controlled clinical trial of selpercatinib versus placebo in patients with 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 NSCLC. The primary endpoint is EFS as assessed by investigator in the primary analysis population, which was comprised of patients with stage II-IIIA RET fusion-positive NSCLC. Secondary endpoints include EFS as assessed by investigator in the overall population, overall survival (OS), EFS as assessed by blinded independent central review (BICR), time to distant disease recurrence in the central nervous system (CNS) as assessed by investigator and BICR, progression-free survival on the next line of treatment (PFS2), positive predictive value (PPV) of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test, safety and tolerability.
