Phase III KEYNOTE-426 trial of Keytruda + Inlyta meets primary endpoints in renal cell carcinoma.- Merck Inc. + Pfizer.

Merck Inc announced that the pivotal Phase III 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.

The dual primary endpoints of the study were OS and PFS, and the key secondary endpoint was ORR. Additional secondary endpoints were disease control rate (DCR), number of participants who experienced or discontinued the study due to an adverse event (AE), duration of response (DOR), PFS at 12, 18 and 24 months and OS at 12, 18 and 24 months. In the trial, 861 patients were randomly assigned to receive Keytruda 200 mg intravenously every three weeks plus Inlyta 5 mg orally twice daily for up to 24 months, or sunitinib 50 mg orally once daily for four weeks followed by no treatment for two weeks, continuously.