A pivotal Phase III trial investigating a combination of MSD’s anti-PD-1 therapy Keytruda and Pfizer’s tyrosine kinase inhibitor Inlyta has shown a significant benefit on both overall (OS) and progression-free survival (PFS) in patients with kidney cancer.
MSD says the KEYNOTE-426 met both primary endpoints in demonstrating statistically significant and clinically meaningful increases in OS and PFS in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC), compared to sunitinib monotherapy.
The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for the Keytruda (pembrolizumab)/Inlyta (axitinib) combination compared with sunitinib.
Results for OS, PFS and ORR were consistent regardless of PD-L1 expression and across all risk groups, while the safety profile of the combination “was generally consistent with that observed in previously reported studies for each therapy,” MSD noted.
The results are to be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.