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Based on the findings from the pivotal phase III JAVELIN Renal 101 study, the European Commission has approved avelumab in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC).
JAVELIN Renal 101 demonstrated that avelumab in combination with axitinib significantly lowered risk of disease progression or death by 31% and nearly doubled objective response rate (52.5%) compared with sunitinib (27.3%) in patients with advanced RCC regardless of whether the patients were PD-L1 positive or negative or their prognostic risk group (low, intermediate or high).
Progression-free survival was also improved in some groups of patients receiving the treatment combination.
“There is a high incidence of kidney cancer in Europe, and for the most common type, renal cell carcinoma, we continue to need additional treatment options, particularly for patients with advanced disease, where outcomes are poorest,” said Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden Hospital. “We’ve seen a demonstrated efficacy benefit and safety and tolerability profile for avelumab in combination with axitinib across all prognostic risk groups in patients with advanced renal cell carcinoma, so today’s approval in Europe brings an important option that can help healthcare professionals optimise treatment strategies across risk stratification.”
The approval allows marketing of the avelumab plus axitinib combination in all 28 EU member states plus Iceland, Lichtenstein and Norway. NICE will be appraising the combination for use within NHS England in January 2020.