Eli Lilly and Company (LLY) announced that its drug Retevmo delivered substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer in a phase 3 trial, dubbed LIBRETTO-432.
Also, the company noted that overall survival results trended in favor of Retevmo (selpercatinib) but were immature at the time of the analysis with few events observed.
LIBRETTO-432 is a phase 3, global, multicenter, randomised, double-blind, controlled clinical trial of Retevmo versus placebo as adjuvant therapy in patients with early-stage (II-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
The trial enrolled 151 patients who were randomised 1:1 to receive either Retevmo or placebo as adjuvant therapy for RET fusion-positive NSCLC.
The primary endpoint is event-free survival (EFS), and the secondary endpoints include EFS in the overall population, overall survival (OS), EFS assessed by blinded independent central review (BICR), time to distant disease recurrence in the central nervous system (CNS) as assessed by investigator and BICR, progression-free survival on the next line of treatment (PFS2), positive predictive value (PPV) of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test, safety and tolerability.
The overall safety profile of Retevmo in LIBRETTO-432 was generally consistent with previously reported trials in the Retevmo development program as reported.
Eli Lilly will present the detailed results at an upcoming medical congress, submit them to a peer-reviewed journal, and discuss them with health authorities globally.
Non-small cell lung cancer or 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.
Retevmo (selpercatinib, formerly known as LOXO-292) is a selective RET kinase inhibitor with central nervous system (CNS) activity and is approved for the treatment of certain cancers caused by abnormal RET genes.
It is the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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."
In parallel, Eli Lilly also announced that it will participate in TD Cowen's 46th Annual Health Care Conference on March 2, 2026.
LLY closed Friday's trade at $1040, up 0.33%. In the overnight market, LLY is up 0.29%, at $1042.98.
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