Based on the findings from the pivotal phase 3 KEYNOTE-426 trial, the European Commission has today approved pembrolizumab (anti-PD-1 therapy) in combination with axitinib (tyrosine kinase inhibitor) for patients with untreated, advanced renal cell carcinoma (RCC).
The KEYNOTE-426 trial demonstrated a reduced risk of death by 47% with the combination compared to sunitinib in patients with advanced RCC. The pembrolizumab plus axitinib combination also showed improved progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib.
“Advanced renal cell carcinoma is one of the most lethal types of cancer, with the majority of patients dying within five years of their initial diagnosis,” said Prof. Thomas Powles, lead investigator for KEYNOTE-426 and director of Barts Cancer Centre. “It’s encouraging that we can now offer patients in Europe the Keytruda [pembrolizumab] with axitinib combination as a first-line treatment option.”
The approval allows marketing of the pembrolizumab combination in all 28 EU member states plus Iceland, Lichtenstein and Norway.