Global pharma powerhouse Eli Lilly and Company has announced groundbreaking results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo (selpercatinib) delivers a significant event-free survival (EFS) benefit as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer (NSCLC).

 

The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease. Overall survival trends also favored Retevmo, though data remain immature. The drug’s safety profile was consistent with previous studies.

 

Jacob Van Naarden, Lilly Oncology’s executive vice president and president, emphasized the importance of early intervention: "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. 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."

 

LIBRETTO-432 is the first and only randomized Phase 3 trial evaluating a selective RET kinase inhibitor as adjuvant therapy in this population. The study enrolled 151 patients, with participants randomized 1:1 to receive either Retevmo or placebo after surgery or definitive radiotherapy.

 

Retevmo, a highly selective RET kinase inhibitor with CNS activity, is FDA-approved for adults with RET fusion-positive NSCLC. The drug is taken orally, twice daily, until disease progression or unacceptable toxicity.