Clear cell renal cancer is the most common type of kidney cancer, comprising 80% of all malignant tumors found within the kidney.
The subcutaneous formulation of Opdivo used Halozyme Therapeutics Inc.'s (NASDAQ: HALO) recombinant human hyaluronidase.
The 495-patient study met its co-primary pharmacokinetics endpoints and key secondary endpoint.
In the first-ever disclosure for the subcutaneous formulation of Opdivo, the CheckMate -67T Phase 3 trial demonstrates activity in advanced or metastatic clear cell renal cell carcinoma.
Also Read: Bristol Myers Squibb Highlights Opdivo Regime Data In Lung Cancer Settings
Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study's co-primary endpoints.
Additionally, subcutaneous nivolumab showed a non-inferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint.
The safety profile of subcutaneous nivolumab was consistent with the IV formulation.
The company will complete a full evaluation of the available CheckMate -67T trial data and work with investigators to present the results at an upcoming medical conference.
Price Action: BMY shares are up 0.05% at $56.88 on the last check Thursday.
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