Bristol Myers Squibb Reports Positive Results From Phase 3 CheckMate-67T Trial

(RTTNews) - Halozyme Therapeutics, Inc. (HALO) Thursday said Bristol Myers Squibb (BMS) reported positive topline results from the Phase 3 CheckMate-67T trial evaluating subcutaneous Opdivo (nivolumab) with Halozyme's ENHANZE drug delivery technology for the treatment of clear cell renal cell carcinoma (ccRCC).

The trial evaluated subcutaneous nivolumab with Halozyme's ENHANZE drug delivery technology compared to intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.

The study met its co-primary pharmacokinetics endpoints showing noninferiority of time-averaged Opdivo serum concentration over 28 days (Cavgd28) and trough serum concentration at steady state (Cminss) compared to intravenous (IV) nivolumab. Further, subcutaneous nivolumab showed noninferiority of objective response rate (ORR) by Blinded Independent Central Review (BICR) vs. IV nivolumab, a key secondary endpoint.