In patients with advanced, radioiodine-refractory, differentiated thyroid cancer (RR-DTC) with and without prior exposure to vascular endothelial growth factor (VEGF) therapy, the encouraging response rates, median time to response, and progression-free survival for lenvatinib have prompted further investigation in a phase 3 trial, a recent study published in the journal Cancer has shown.
For the phase 2 study, researchers enrolled 58 patients with RR-DTC who had disease progression during the previous 12 months.
All participants received lenvatinib 24mg once daily in 28-day cycles until disease progression, unacceptable toxicity, withdrawal, or death.
Results showed that after 14 or more months of follow-up, patients had an objective response rate of 50% (95% CI: 37-63). All responses were partial responses.
For patients who had received previous VEGF therapy, the objective response rate was 59% (95% CI: 33-82).
The study also showed a median time to response of 3.6 months, a median duration of response of 12.7 months, and a median progression-free survival of 12.6 months (95% CI: 9.99-16.1).
Researchers found that lower baseline levels of angiopoietin-2 were indicative of tumor response and longer progression-free survival.
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In regard to safety, the most common grade 3 or 4 treatment-related adverse events were weight loss, hypertension, proteinuria, and diarrhea.
Lenvatinib was approved by the U.S. Food and Drug Administration (FDA) earlier this year for the treatment of patients with locally recurrent or metastatic, progressive, RR-DTC.