The EC approval for the combination treatment is based on the Phase III JAVELIN Renal 101 study, which showed positive results
Merck and Pfizer have secured the European Commission (EC) approval for BAVENCIO (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody, which is being co-developed and co-commercialised by Merck and Pfizer under an alliance established in November 2014.
According to the preclinical models, BAVENCIO releases the suppression of the T cell-mediated anti-tumour immune response by blocking the interaction of PD-L1 with PD-1 receptors.
Merck 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.
“RCC is the most common form of kidney cancer, accounting for 90% of diagnoses. We are now working to make BAVENCIO in combination with axitinib available for patients with advanced renal cell carcinoma as quickly as possible.”
Phase III JAVELIN Renal 101 study of BAVENCIO and axitinib combination
In May 2019, the US Food and Drug Administration (FDA) has approved BAVENCIO in combination with axitinib for the first-line treatment of patients with advanced RCC.
The EC approval for BAVENCIO and axitinib combination treatment is based on the Phase III JAVELIN Renal 101 study, which showed positive results.
The interim study results demonstrated that the combination treatment reduced the risk of disease progression or death by 31% and almost doubled objective response rate (ORR) compared with sunitinib in patients with advanced RCC regardless of PD-L1 status.
Diarrhoea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia are the most common adverse reactions observed in the study.
BAVENCIO in combination with axitinib is recommended in an 800mg dose administered intravenously over 60minutes for every two weeks and 5mg axitinib administered orally twice a day, with or without food until disease progression or unacceptable toxicity.
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.”