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FDA has approved lenvatinib (Lenvima, Eisai Inc.) in combination with everolimus for the treatment of advanced renal cell carcinoma.
With its newest FDA approval, Lenvima is now indicated, in combination with everolimus, for the treatment of patients with advanced RCC who were previously treated with an anti-angiogenic therapy. Everolimus works by inhibiting the mammalian target of rapamycin (mTOR), which is associated with a pathway shown to be dysregulated in several cancers resulting in tumor cell growth and proliferation.
Lenvima is a receptor tyrosine kinase (RTK) inhibitor that blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors as well as other RTKs that have been associated with pathogenic angiogenesis, tumor growth, and cancer progression.
"Lenvatinib plus everolimus is the first and only FDA-approved regimen that successfully combines treatments that employ tyrosine kinase and mTOR inhibition, the primary targets of advanced RCC treatment for the past decade," said Robert Motzer, MD, principal investigator of Study 205 with Memorial Sloan Kettering Cancer Center in New York.
FDA originally approved Lenvima in February, 2015, for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
The availability of a new treatment is important, since it is estimated that approximately 62,700 new cases of kidney cancer will be diagnosed, and about 14,240 people with die from the disease in 2016.
Study 205 is a phase 2, multicenter trial in which patients with unresectable advanced or metastatic RCC who were previously treated with an anti-angiogenic therapy. Patients were randomized to receive a once-daily combination of 18 mg of Lenvima plus 5 mg of everolimus, 24 mg once-daily Lenvima only or 10 mg once-daily everolimus only.
Notably, in patients who had received prior anti-angiogenic treatment, the combination therapy resulted in a median progression-free survival (PFS), or the length of time from randomization until disease progression or death, of 14.6 months compared to 5.5 months with everolimus alone.
Lenvima plus everolimus also demonstrated a 63% reduction in the risk of disease progression or death compared to monotherapy.
The safety of the combination regimen was also evaluated in Study 205 and the most common adverse reactions observed included diarrhea, fatigue, myalgia, decreased appetite, vomiting and nausea. Some of the potential serious risks associated with the use of Lenvima plus everolimus include hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, and renal dysfunction.