The European Commission has approved Merck and Pfizer’s Bavencio (avelumab), in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The companies say that the approval was based on positive interim results from the Phase III JAVELIN Renal 101 study, which found that the combination significantly lowered risk of disease progression or death by 31%, as well as nearly doubling the objective response rate compared to just sunitinib.

The successful results were found in patients with advanced RCC regardless of PD-L1 status, and included patients across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups.

There is a high incidence of kidney cancer in Europe, and so “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 NHS Foundation Trust and Professor at the Institute of Cancer Research (ICR).

The commission announced that the approval follows the US Food and Drug Administration (FDA) decision, which said ‘yes’ to the combination in May 2019.

Professor James continued, “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.”

In 2018, an estimated 136,500 new cases of kidney cancer were diagnosed in Europe, and approximately 54,700 people died from the disease. The five-year survival rate for patients with advanced RCC is approximately 12%.