Lilly's Retevmo hits PFS goal in medullary thyroid cancer study
22 Aug 2023
Phase 3Clinical ResultAccelerated ApprovalADC
Eli Lilly's oral RET blocker Retevmo (selpercatinib) outperformed multikinase inhibitors in a Phase III study by significantly extending progression-free survival (PFS) in patients with medullary thyroid cancer (MTC), according to top-line results unveiled Tuesday. "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 MTC," said David Hyman, chief medical officer at Loxo@Lilly.
LIBRETTO-531 included 291 patients with progressive, advanced kinase inhibitor-naïve RET-mutant MTC who were randomly assigned to receive Retevmo or physician's choice of Exelixis and Ipsen's Cabometyx (cabozantinib) or Sanofi's Caprelsa (vandetanib) as an initial treatment. Eli Lilly said the trial achieved its primary endpoint with a "statistically significant and clinically meaningful improvement" in PFS based on a pre-specified interim efficacy analysis.
Secondary goals include treatment failure-free survival, overall response rate (ORR), duration of response and overall survival. Full results from LIBRETTO-531 will be presented at an upcoming medical meeting, submitted to a peer-reviewed journal and discussed with health authorities.
Retevmo received an accelerated approval from the FDA in 2020 for RET-positive non-small-cell lung cancer (NSCLC) and thyroid cancers that was subsequently converted to a full authorisation last year. At the same time as last year's switch to full approval, it received an accelerated US nod for locally advanced or metastatic solid tumours with a RET gene fusion. That decision was based on data from the Phase I/II LIBRETTO-001 study where Retevmo showed an ORR of 44%.
Meanwhile, the company recently reported that Retevmo showed superior PFS compared to a combination of Merck & Co.'s anti-PD-1 antibody Keytruda (pembrolizumab) plus chemotherapy in LIBRETTO-431, another Phase III trial involving NSCLC patients. For a closer look at that study, see KOL Views Q&A: LIBRETTO-431 data go beyond cementing Retevmo’s place in NSCLC landscape.
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