German approval pending for RCC combo therapy benefit

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Eisai (Tokyo), a maker of cancer and neurological therapies, is closer to gaining a proven new benefit for its renal cancer treatment, lenvatinib (Kisplyx), in Germany, where 15,000 people develop renal cell carcinoma (RCC) every year.

The German Institute for Quality and Efficiency in Health Care (IQWiG) published conclusions that lenvatinib when delivered in combination with everolimus has additional benefits in patients with RCC. The results of the institute’s report were announced by Eisai on Jan. 4, 2017, and will be evaluated by Germany’s Federal Joint Committee. A final decision on whether to accept results from the IQWiG report is expected in March 2017.

Eisai submitted phase 2 trial data of 153 people with advanced RCC who had progressed after one previous vascular endothelial growth factor (VEGF) therapy. Patients were randomized to either receive everolimus or lenvatinib monotherapy, or a combination of both. The results showed significant differences in efficacy between the combination treatment and everolimus therapy alone.

When treated with lenvatinib in combination with everolimus, patients experienced a median progression-free survival of 14.6 months compared with 5.5 months for a group of 50 patients who received everolimus alone (p=0.0005). Median overall survival 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 European Commission, as well as the FDA, granted marketing authorization in 2016 for lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma after one VEGF therapy.