Eli Lilly’s oral targeted cancer therapy, Retevmo, has shown benefit as an adjunctive therapy in a Phase III trial in patients with early-stage (II-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
In the LIBRETTO-432 trial (NCT04819100), Retevmo (selpercatinib) demonstrated a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS), meeting the trial’s primary endpoint, compared to placebo. Patients enrolled in the trial were dosed with Retevmo or placebo after receiving surgery or radiation.
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Overall survival (OS) also trended in favour of Retevmo, but data were immature at the time of analysis, with few events observed. The overall safety profile of Retevmo in LIBRETTO-432 was generally consistent with previously reported trials.
Lilly said that more detailed results will be presented at an upcoming medical congress, submitted to a peer-reviewed journal, and discussed with health authorities globally.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, said: “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.”
Lilly said that LIBRETTO-432 is the first randomised Phase III trial to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population.
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By GlobalDataNSCLC accounts for about 85% of all lung cancer diagnoses in the US, and around 30% of those present with stage IB-IIIA disease.
Lilly’s Retevmo is already US Food and Drug Administration (FDA) approved in locally advanced or metastatic NSCLC, advanced or metastatic medullary thyroid cancer (MTC), advanced or metastatic thyroid cancer and locally advanced or metastatic solid tumour. All patients must also have a rearranged during transfection (RET) gene fusion or mutation.
According to GlobalData, the drug has a global sales forecast of $624m in 2031. GlobalData is the parent company of Clinical Trials Arena.
