Selpercatinib prolongs PFS in RET-mutant medullary thyroid cancer
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Selpercatinib extended PFS compared with two approved multikinase inhibitors for treatment of RET-mutant medullary thyroid cancer, according to 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 non-small cell lung cancer as detected by an FDA-approved test.
RET mutations occur in approximately 60% of sporadic medullary thyroid cancers and more than 90% of hereditary medullary thyroid cancers.
The randomized phase 3 LIBRETTO-531 study included 291 patients with advanced or metastatic RET-mutant medullary thyroid cancer.
Researchers assigned patients 2:1 to selpercatinib or physician’s choice of cabozantinib (Cabometyx, Exelixis) or vandetanib (Caprelsa, Sanofi) as initial treatment. Cabozantinib and vandetanib are approved first-line options for this patient population.
The study achieved its primary endpoint, as a prespecified interim efficacy analysis performed by an independent data monitoring committee showed a statistically significant and clinically meaningful PFS improvement among selpercatinib-treated 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, MD, chief medical officer for Loxo@Lilly, said in an Eli Lilly & Co. press release. “Taken together with the recent positive Retevmo phase 3 LIBRETTO-431 announcement in lung cancer, these results underscore the importance of timely and broad-based genomic testing to ensure patients who could potentially benefit receive targeted therapies.”
Complete results from LIBRETTO-531 will be presented at a medical meeting and shared with health authorities, according to the release.
Adverse events observed in the selpercatinib group appeared generally consistent with those reported in prior studies.
Selpercatinib labeling includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, tumor lysis syndrome, hypothyroidism, embryo-fetal toxicity and risk for impaired wound healing.
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