Global pharma powerhouse Lilly and Company has announced that its trial of Retevmo met its primary endpoint, showing breakthrough results in early-stage lung cancer trial.

 

The phase 3 LIBRETTO-432 trial of Retevmo (selpercatinib) as adjuvant therapy delivered a “highly statistically significant and clinically meaningful” improvement in event-free survival (EFS) for patients with early-stage (II–IIIA) RET fusion-positive non-small cell lung cancer (NSCLC), as per the company.

 

While overall survival results are still immature, they trended in favor of selpercatinib. The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns. Detailed data will be unveiled at an upcoming medical congress, submitted to a peer-reviewed journal, and discussed with regulators worldwide.

 

“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.”

 

LIBRETTO-432 is the first and only randomized Phase 3 study evaluating a selective RET kinase inhibitor as adjuvant therapy in this patient population. NSCLC represents roughly 85% of all U.S. lung cancer cases, with 30% of patients diagnosed at stage IB–IIIA. RET fusions are found in 1–2% of NSCLC cases, and about half of all patients have actionable biomarkers.

 

The trial enrolled 151 patients, randomized 1:1 to receive either selpercatinib or placebo following surgery or radiotherapy. The primary endpoint was investigator-assessed EFS in stage II–IIIA RET fusion-positive patients. Secondary endpoints included overall survival, blinded independent central review of EFS, time to distant CNS recurrence, progression-free survival on next-line therapy, RET test predictive value, and safety and tolerability.