Clinical Trials

Eli Lilly has announced topline results from the LIBRETTO-531 study assessing Retevmo (selpercatinib) as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).

LIBRETTO-531 was the first randomised trial to compare the safety and effectiveness of a highly selective RET-kinase inhibitor versus multikinase inhibitors (MKIs) for this indication; the trial compared Retevmo with MKIs cabozantinib or vendetanib for this indication. It met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

David Hyman MD, chief medical officer of Loxo@Lilly, commented: "These data from the LIBRETTO-531 trial confirm the importance of selectivity in targeting RET-driven cancers and suggest Retevmo should be considered the preferred first-line treatment for people with advanced RET-mutant medullary thyroid cancer. Taken together with the recent positive Retevmo phase 3 LIBRETTO-431 announcement in lung cancer, these results underscore the importance of timely and broad-based genomic testing to ensure patients who could potentially benefit receive targeted therapies. We look forward to sharing detailed data with the oncology community."

Full results of this trial will be presented at an upcoming medical meeting, submitted to a peer-reviewed journal and ultimately discussed with the relevant health authorities.