Bristol Opdivo As Under Skin Injection At Par With Intravenous Infusion In Kidney Cancer

Bristol Myers Squibb & Co 

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 released the first disclosure of data from the Phase 3 CheckMate -67T trial of the subcutaneous formulation of Opdivo (nivolumab) compared to intravenous (IV) Opdivo in advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. 

The subcutaneous Opdivo is co-formulated with Halozyme Therapeutics Inc’s 

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 recombinant human hyaluronidase.

In the CheckMate -67T trial investigating subcutaneous nivolumab (n=248) vs. IV Opdivo (n=247):

• The data showed noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo. 
• In addition, subcutaneous nivolumab displayed a non-inferior objective response rate (ORR) vs. IV Opdivo. 
• Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the time-averaged serum concentration over the first 28 days, with a geometric mean ratio of 2.098.
  
• Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the minimum serum concentration at steady state, with a geometric mean ratio of 1.774.
• The secondary endpoint of ORR with subcutaneous nivolumab demonstrated an ORR of 24.2% vs. 18.2% with IV Opdivo.
• Median progression-free survival with subcutaneous nivolumab was 7.23 months and 5.65 months with IV Opdivo.

The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

https://www.benzinga.com/general/biotech/24/01/36822522/bristol-myers-lead-cancer-drug-opdivo-formulated-as-under-skin-injection-at-par-with-intravenous-