The European Commission (EC) has approved MSD’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

The anti-PD-1 therapy combo was approved based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that the drug reduced the risk of death by 47% compared with sunitinib in the indication.

The combination also demonstrated an improvement in progression-free survival (PFS) and objective response rate (ORR) compared with 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 Professor 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 with axitinib combination as a first-line treatment option.”

The approval allows marketing of the Keytruda combination in all 28 EU member states plus Iceland, Lichtenstein and Norway.

Dr. Scot Ebbinghaus, vice president, clinical research, MSD Research Laboratories said that the European approval for the treatment of advanced RCC “marks an important milestone in our efforts for patients with this aggressive disease. Offering an additional treatment option in the first-line setting is particularly important in patients with advanced RCC and underscores our commitment to develop Keytruda in areas of unmet need.”

The decision comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the combo in July.

RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are renal cell carcinomas. There were approximately 403,000 cases of kidney cancer diagnosed worldwide in 2018 and about 175,000 deaths from the disease.