Selpercatinib prolongs PFS in RET fusion-positive NSCLC
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Selpercatinib extended PFS compared with a PD-1 inhibitor-chemotherapy combination for certain adults with advanced non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Selpercatinib (Retevmo, Eli Lilly & Co.) — a kinase inhibitor — received FDA approval last year for treatment of adults with locally advanced or metastatic RET fusion-positive NSCLC as detected by an FDA-approved test.
RET fusions typically occur in 1% to 2% of NSCLC cases.
The randomized phase 3 LIBRETTO-431 study compared selpercatinib with platinum-based chemotherapy plus pemetrexed with or without pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — as initial treatment for patients with RET fusion-positive advanced or metastatic NSCLC.
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS with selpercatinib, according to an Eli Lilly & Co. press release.
Adverse events appeared consistent with those reported in prior studies.
"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, MD, chief medical officer for Loxo@Lilly, said in the release. “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 results of this study provide further confirmation that RET status — like EGFR, ALK, and others in the family of lung cancer oncogenic drivers — should be known prior to initiating therapy.”
Complete results from LIBRETTO-431 will be presented at a medical meeting, according to the release.
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