Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai” ) announced today that the German Federal Joint Committee (G-BA) has confirmed the additional benefit of in-house developed anticancer agent Kisplyx® (lenvatinib mesylate) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC) compared to everolimus alone in its assessment for insurance reimbursement. Based on this additional benefit assessment, price negotiations with the Head Association of German Sick Funds (GKV-SV) will be conducted, and a reimbursement price has to be agreed.

The G-BA’s assessment was based on a Phase II clinical study (Study 205) that evaluated the safety and efficacy of Kisplyx in combination with everolimus in patients with unresectable advanced or metastatic RCC following one prior vascular endothelial growth factor (VEGF) targeted therapy. From the results of the study, the Kisplyx plus everolimus group demonstrated a significant extension in the study’s primary endpoint of progression free survival (PFS) compared to the everolimus alone group. Furthermore, the Kisplyx plus everolimus group demonstrated an extension in median overall survival (OS) compared to the everolimus alone group.
The most common treatment-emergent adverse events (TEAEs) reported in the Kisplyx plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) were diarrhea, hypertension and fatigue

The number of patients with renal cancer is estimated to be approximately 115,000 in Europe in 2012. Renal cell carcinoma comprises more than 90% of all malignancies of the kidney, and originates from malignant cells in the lining of the tubules of the kidney. The incidence of renal cell carcinoma in people over 55 years of age is rising, and it is more likely to affect men than women. For advanced or metastatic RCC that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy. However, with low 5-year survival rates, RCC remains a disease with a significant unmet medical need.

In Europe, lenvatinib mesylate has been designated as an orphan drug for thyroid cancer and is marketed as Lenvima® for this indication.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to expanding access to Kisplyx and maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.