The phase 3 CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo ( Nivolumab ) co-formulated with Halozyme’s recombinant human hyaluronidase ( rHuPH20 ) compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma ( ccRCC ) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint.
Subcutaneous Nivolumab has demonstrated noninferiority of Cavgd28 ( time-averaged Opdivo serum concentration over 28 days ) and Cminss ( trough serum concentration at steady state ) compared to intravenous Opdivo, the study’s co-primary endpoints.

Additionally, subcutaneous Nivolumab has shown a noninferior objective response rate ( ORR ) as assessed by Blinded Independent Central Review ( BICR ) versus intravenous Opdivo, a key secondary endpoint. The safety profile of subcutaneous Nivolumab was consistent with the intravenous formulation.

CheckMate -67T is a phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s recombinant human hyaluronidase, rHuPH20, or subcutaneous Nivolumab ( Nivolumab and Hyaluronidase ) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy.
A total of 495 patients were randomized to either subcutaneous Nivolumab or intravenous Opdivo.
The co-primary endpoints of the trial are time-averaged serum concentration over 28 days ( Cavgd28 ) and trough serum concentration at steady-state ( Cminss ) of subcutaneous Nivolumab versus intravenous Opdivo.
Objective response rate ( ORR ) is a key secondary endpoint.

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year.
Renal cell carcinoma is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe.
Clear cell renal carcinoma ( ccRCC ) is the most common form of renal cell carcinoma, affecting about 7 out of 10 people with renal cell carcinoma.
The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival ( DFS ) rates for those with localized disease that can be resected are just over 50%. ( Xagena_2023 )

Source: Bristol Myer Squibb ( BMS ), 2023

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