The European Commission (EC) has approved avelumab in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The approval was based on positive interim results from the Phase III JAVELIN Renal 101 study, which demonstrated that BAVENCIO in combination with axitinib significantly lowered risk of disease progression or death by 31% (HR: 0.69 [95% CI: 0.574–0.825; p<0.0001]) and nearly doubled objective response rate (ORR; 52.5% [95% CI: 47.7-57.2] vs. 27.3% [95% CI: 23.2-31.6]) compared with sunitinib in patients with advanced RCC regardless of PD-L1 status.

The study included patients across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups.

Improvement in progression-free survival (PFS) was observed across pre-specified subgroups in 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 NHS Foundation Trust and Professor at the Institute of Cancer Research (ICR).

"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 optimize 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.

Many patients living with advanced RCC do not go on to receive additional treatment after first-line therapy, for reasons that may include poor performance status or adverse events from their initial treatment.

The five-year survival rate for patients with advanced RCC is approximately 12%.7

The EC's decision follows the U.S. Food and Drug Administration (FDA) approval of avelumab in combination with axitinib for the first-line treatment of patients with advanced RCC in May 2019.

A supplemental application for avelumab in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.

Source: Syneos Health