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Eli Lilly to Discuss Positive Head-to-Head Retevmo Data in RET-Positive NSCLC With Regulators

NEW YORK – Eli Lilly on Friday said it would discuss with health authorities Phase III trial results showing that patients with RET fusion-positive non-small cell lung cancer had longer median progression-free survival on Retevmo (selpercatinib) than with chemotherapy with or without immunotherapy.

Researchers evaluated the RET inhibitor Retevmo against chemo with or without Merck's checkpoint inhibitor Keytruda (pembrolizumab) in newly diagnosed RET-positive NSCLC patients in the LIBRETTO-431 study. Lilly said the study met its primary endpoint of progression-free survival.

"The LIBRETTO-431 trial aims to answer an important question about the selection of initial treatment for people with advanced RET fusion-positive NSCLC, and these results suggest Retevmo should be considered a first-line standard of care," David Hyman, chief medical officer at Lilly subsidiary Loxo@Lilly, said in a statement "Additionally, this clinically meaningful achievement of improved outcomes underscores the importance of timely and comprehensive genomic testing to inform initial treatment decisions for all patients with NSCLC."

The US Food and Drug Administration granted accelerated approval to Retevmo as a line-agnostic treatment for RET-positive locally advanced or metastatic NSCLC in 2020. The accelerated approval was based on overall response rates seen in the Phase I/II LIBRETTO-001 study, which included both previously treated and untreated patients. The latest Phase III findings may provide the confirmatory efficacy data needed to convert Retevmo's accelerated approval into a full approval in this setting.

Retevmo also has accelerated approval in the US to treat adult and pediatric RET-mutant thyroid cancer and as a tumor-agnostic treatment for locally advanced or metastatic solid tumors harboring RET gene fusions.

In Europe, the drug, marketed as Retsevmo, was granted conditional authorization for both previously treated and untreated RET-positive NSCLC patients. In the UK, Retsevmo is available through the Cancer Drugs Fund for previously treated NSCLC patients only, while more data is being collected.

Lilly will present the full LIBRETTO-431 study results at an upcoming medical meeting and submit the data for publication to a peer-reviewed journal.