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Renal Cancer Drug Lenvatinib Meets Primary Endpoint in Mid-Stage Trial

Treatment prolongs progression-free survival

The phase II part of a phase I/II clinical trial (Study 205) of the anticancer agent lenvatinib mesylate (Eisai Co., Ltd.) in unresectable advanced or metastatic renal cell carcinoma (RCC) has met its primary endpoint.

The second part of Study 205 was an open-label, multicenter study of lenvatinib alone and in combination with the anticancer agent everolimus in patients with unresectable advanced or metastatic RCC after one prior vascular endothelia growth factor (VEGF)-targeted treatment. A total of 153 patients were randomly assigned to one of three treatment groups: lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib (24 mg) alone, or everolimus (10 mg) alone.

From the preliminary results of the study, both lenvatinib plus everolimus and lenvatinib alone prolonged progression-free survival (PFS), the study’s primary endpoint, compared with everolimus alone. The lenvatinib/everolimus group, in particular, showed a statistically significant improvement.

The most common treatment-related adverse events reported in the lenvatinib/everolimus arm included diarrhea, decreased appetite, fatigue, nausea, and hypertension, and in the lenvatinib-alone group were diarrhea, nausea, decreased appetite, hypertension, fatigue, and vomiting.

Molecular-targeted drug therapy is the standard treatment for metastatic or advanced RCC that is difficult to treat with surgery. In the new study, lenvatinib plus everolimus achieved superior PFS compared with everolimus alone, which is recommended by the National Comprehensive Cancer Network guidelines as a second-line therapy for unresectable advanced or metastatic RCC. No combination therapy has been approved for this indication in any major country worldwide.

Lenvatinib is an oral molecular-targeted agent that selectively inhibits the activities of several different molecules involved in angiogenesis and tumor proliferation, including VEGFR, fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).

An application has been submitted to the FDA seeking approval of lenvatinib for the treatment of thyroid cancer. In addition, a global phase III trial of lenvatinib in hepatocellular carcinoma is under way, along with phase II studies in several other tumor types.

Source: Eiasai Co., Ltd.; January 30, 2015.

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