Bavencio, which is a human anti-programmed death ligand-1 (PD-L1) antibody, has been demonstrated 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 showed that Bavencio plus axitinib significantly reduced risk of disease progression or death by 31% and nearly doubled objective response rate versus 27.3% compared with 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 recruited patients from International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups.
Merck KGaA Biopharma business innovative medicine franchises global head Rehan Verjee said: “This first European approval of an anti-PD-L1 as part of a combination treatment for advanced renal cell carcinoma builds on our commitment to bringing innovative treatment options to patients with hard-to-treat cancers through our extensive JAVELIN clinical trial program.”
In May this year, 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 January this year, a supplemental application for Bavencio in combination with axitinib in unresectable or metastatic RCC was submitted in Japan.
Pfizer Oncology global president Andy Schmeltz said: “The European Commission approval of BAVENCIO in combination with axitinib has the potential to bring even more patients with advanced renal cell carcinoma a new first-line treatment, and it allows us to continue to deliver on our more than decade-long passion to do more for patients with kidney cancer.”
In June this year, Pfizer secured approval from the EC for its Talzenna (talazoparib) to treat patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (MBC).