The US Food and Drug Administration (FDA) has approved Merck's Bavencio (avelumab) plus Inlyta (axitinib) combination for patients with advanced renal cell carcinoma.

Merck KGaA and Pfizer announced the combo for the first-line treatment of patients with advanced RCC, making it the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

The decision was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups.

The news is welcome, as there is a significant unmet need for first-line treatments that delay progression and have an acceptable safety profile. Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

Merck KGaA have said they feel “privileged” that they can offer “patients with first-line advanced renal cell carcinoma a new treatment option,” said Rehan Verjee, President of the company.

The European Medicines Agency (EMA) validated the Type II variation application for the combination in advanced RCC in March 2019, and a supplemental application for the combo in unresectable or metastatic RCC was submitted in Japan in January 2019.

RCC is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumour.