European Commission grants approval to Pfizer and Merck's Bavencio in combination with axitinib
30 October 2019 -

The European Commission (EC) has granted approval to United States-based Pfizer and Germany-based Merck KGaA for Bavencio (avelumab) in combination with axitinib as a first-line treatment for adult patients with advanced renal cell carcinoma (RCC), it was reported yesterday.

The product has been showcased in preclinical models to engage both the adaptive and innate immune functions.

The combined therapy has been approved based on the positive interim results from the Phase III JAVELIN Renal 101 study. The study indicated that Bavencio plus axitinib significantly decreased risk of disease progression or death by 31% and around doubled objective response rate compared with 27.3% against sunitinib in patients with advanced RCC regardless of PD-L1 status. JAVELIN Renal 101 is a randomised, multicentre and open-label study of Bavencio in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear cell component. The study hired patients from International Metastatic Renal Cell Carcinoma Database Consortium prognostic risk groups.

The combined therapy also secured approval from the US Food and Drug Administration (FDA) for Bavencio in combination with axitinib as first-line treatment for patients with advanced RCC, in May this year.