German IQWiG concludes additional benefits of Kisplyx (lenvatinib) plus Affinitor (everolimus) proven in advanced renal cell carcinoma- Eisai

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx (lenvatinib), from Eisai in combination with Affinitor (everolimus) for the treatment of advanced renal cell carcinoma (RCC) versus the established comparator therapy - as defined by the Federal Joint Committee (G-BA) - has been proven. The final decision to implement the report's recommendation lies with the G-BA and is expected for March 2017. It will follow consideration of the IQWiG report, written statements and an oral hearing.

In the pivotal phase II trial (study 205), 153 people living with advanced RCC who had progressed after one previous VEGF therapy were evaluated. In the study, patients were randomised to either receive everolimus or lenvatinib monotherapy, or the combination of both agents. The results from study 205 revealed that there are significant differences in efficacy between the combination treatment and everolimus monotherapy. When treated with lenvatinib in combination with everolimus (n=51), patients experienced a median progression-free survival of 14.6 months compared with 5.5 months for those who received everolimus alone; investigator assessment). Median overall survival (OS) in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group in two update analyses. The absolute difference in median OS of 10.1 months shown in these analyses suggests a large and sustained improvement in overall survival.