Bristol Myers announces first disclosure of data from Phase 3 CheckMate -67T

Bristol Myers Squibb announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy, demonstrating noninferiority for the co-primary endpoints of Cavgd28 and Cminss compared to IV Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate as assessed by Blinded Independent Central Review vs. IV Opdivo. The safety profile of subcutaneous nivolumab was consistent with the IV formulation. Incidence of local injection site reactions with subcutaneous nivolumab was 8.1%. Additionally, reactions were low grade and transient. Among patients treated with subcutaneous nivolumab, grade 3-4 adverse events occurred in 35.2% of patients vs. 40.8% of patients treated with IV Opdivo. Treatment-related AEs occurred in 9.7% vs. 14.7% of patients, serious AEs in 21.1% vs. 22.9% of patients and treatment-related serious AEs in 6.5% of patients for both the subcutaneous and IV formulations.