Lilly’s Retevmo highlights substantial event free survival benefit as an adjuvant therapy in early stage RET fusion-positive lung cancer

Eli Lilly has recently announced their new positive topline results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo 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 in patients with early-stage rearranged during transfection fusion-positive non-small cell lung cancer.

Note that the 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.

“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.”

In addition, 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.

Please note that 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.

---

---

Related Topics and Keywords

Lilly's Retevmo, lung cancer, retevmo