INDIANAPOLIS (dpa-AFX) - Drug major Eli Lilly and Co. (LLY) announced Monday positive topline results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo.
The trail met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) in patients with early-stage (II-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer or NSCLC.
Retevmo is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. It may affect both tumor cells and healthy cells, which can result in side effects.
Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight, taken twice daily until disease progression or unacceptable toxicity.
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.
The company noted that 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.
The company plans to present detailed results of the trial at an upcoming medical congress, submit to a peer-reviewed journal, and to discuss with worldwide health authorities.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, said, '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.'
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