NEW YORK – Eli Lilly on Tuesday said it will discuss with health authorities data from a Phase III trial showing Retevmo's (selpercatinib) potential as a first-line treatment for RET-mutant medullary thyroid cancer.
In the Phase III LIBRETTO-531 study, Lilly compared Retevmo's activity against two kinase inhibitors, Exelixis' Cabometyx (cabozantinib) or Sanofi's Caprelsa (vandetanib), in patients with advanced RET-mutant medullary thyroid cancer. Cabometyx and Caprelsa are standard first-line options for advanced medullary thyroid cancer patients, regardless of their biomarker status. According to Lilly, LIBRETTO-531 met its primary endpoint, with Retevmo demonstrating a clinically meaningful improvement in progression-free survival.
The US Food and Drug Administration granted Retevmo accelerated approval in 2020 as a treatment for patients with RET-mutant advanced medullary thyroid cancer who require systemic therapy. That accelerated approval was based on data from the Phase I/II LIBRETTO-001 trial, which showed high response rates to Retevmo both in patients who had previously received Cabometyx and Caprelsa and those who hadn't.
The latest data from the randomized LIBRETTO-531 trial comparing Retevmo's benefit against standard-of-care drugs may provide the confirmatory evidence needed to convert the drug's accelerated approval into full approval as a first-line treatment for RET-mutated advanced medullary thyroid cancer patients.
"These data from the LIBRETTO-531 trial confirm the importance of selectivity in targeting RET-driven cancers and suggest Retevmo should be considered the preferred first-line treatment for people with advanced RET-mutant medullary thyroid cancer," David Hyman, chief medical officer at Lilly subsidiary Loxo@Lilly, said in a statement.
Hyman also highlighted recent Phase III data showing Retevmo improved progression-free survival for patients with RET-positive non-small cell lung cancer. "These results underscore the importance of timely and broad-based genomic testing to ensure patients who could potentially benefit receive targeted therapies," Hyman continued.
Lilly said it will present full findings from LIBRETTO-531 at an upcoming medical meeting and submit the data for publication in a peer-reviewed journal.