Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans to submit the data to global regulatory authorities in the near future.

According to the first interim analysis by an IDMC, Keytruda plus Inlyta significantly improved overall survival (OS) and progression-free survival (PFS) vs. Sutent. The combination also met the secondary endpoint of improving objective response rate (ORR) vs. Sutent. The company said data for OS, PFS and ORR were consistent regardless of PD-L1 expression and across all risk groups. Details were not disclosed, but Merck plans to present the data at an upcoming medical meeting...