Posted by Michael Wonder on 05 Sep 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination with axitinib compared to sunitinib.
Merck today announced that the European Commission has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
This approval includes patients in all IMDC risk groups. It is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated that Keytruda in combination with axitinib reduced the risk of death by 47% compared with sunitinib (HR=0.53 [95% CI, 0.38, 0.74]; p=0.00005) in patients with advanced RCC.
