Eli Lilly Announces Positive Phase 3 Results for Retevmo in NSCLC

Eli Lilly Announces Positive Phase 3 Results for Retevmo in NSCLC

Eli Lilly and Company reported positive topline results from the phase 3 LIBRETTO-432 trial evaluating Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive non-small cell lung cancer (NSCLC). The study achieved its primary endpoint, showing a highly significant improvement in event-free survival (EFS) assessed by investigators.

Overall survival results showed a favorable trend for Retevmo, although the data remain immature due to limited events observed. The drug's safety profile in LIBRETTO-432 was consistent with prior trials in its development program.

Jacob Van Naarden, executive vice president and president of Lilly Oncology, said, "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."

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This trial is the first randomized phase 3 study assessing a selective RET kinase inhibitor as adjuvant therapy for this population. NSCLC represents about 85% of lung cancer cases in the U.S., with 30% presenting at stage IB-IIIA. RET fusions occur in 1-2% of all NSCLC cases, highlighting the need for targeted therapies.

Retevmo is a potent, selective RET kinase inhibitor with central nervous system activity, taken orally twice daily based on weight. It is FDA-approved for adult patients with locally advanced or metastatic NSCLC harboring RET gene fusions. Detailed results from LIBRETTO-432 will be presented at a medical congress, submitted for peer review, and shared with global health authorities.

Lilly continues its mission to transform science into medicines that improve lives, building on nearly 150 years of pioneering discoveries that impact millions worldwide.