Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).
The equivalence trial successfully met its primary endpoints, including average serum concentration over 28 days and trough serum concentration at steady state, as well as the key secondary endpoint of noninferior objective response rate (ORR). The subcutaneous formulation achieved a median progression-free survival (PFS) of 7.23 months, compared to 5.65 months for the intravenous infusion, with both formulations exhibiting comparable safety profiles.- Flcube.com
