Merck’s KEYTRUDA in Combination with Pfizer’s Inlyta Significantly Improved Overall Survival

Merck, known as MSD outside the United States and Canada, announced that the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the first-line treatment of advanced or metastatic renal cell carcinoma (RCC), the most common type of kidney cancer. Based on the first interim analysis by the independent Data Monitoring Committee (DMC), the KEYTRUDA plus Inlyta combination resulted in statistically significant and clinically meaningful improvements in OS and PFS, compared to sunitinib monotherapy. The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for the KEYTRUDA and Inlyta combination compared with sunitinib monotherapy. Results for OS, PFS and ORR were consistent regardless of PD-L1 expression and across all risk groups. The safety profile of KEYTRUDA and Inlyta in this trial was generally consistent with that observed in previously reported studies for each therapy. These results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.

“KEYTRUDA, in combination with the tyrosine kinase inhibitor Inlyta, resulted in significant and clinically meaningful improvements in overall survival, progression-free survival and objective response in this Phase 3 study. This marks the first time that combination treatment with an anti-PD-1 therapy has achieved the dual primary endpoints of overall survival and progression-free survival as first-line therapy in advanced renal cell carcinoma,” said Dr Roger M. Perlmutter, president, Merck Research Laboratories. “Fewer than 10 percent of those diagnosed with advanced renal cell carcinoma survive for five years, and hence there is significant need for improved therapies for this disease. We are very grateful to the investigators and patients for their involvement in this important study, the results of which will be filed with global regulatory authorities in the near future.” – Medical Buyer Bureau