Dr George on the Efficacy and Safety of Subcutaneous Nivolumab in ccRCC

Saby George, MD, FACP, professor, oncology, medicine, director, Network Clinical Trials, Department of Medicine, Roswell Park Comprehensive Cancer Center and associate professor, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, discusses the efficacy and safety of subcutaneous nivolumab (Opdivo) in patients with clear cell renal cell carcinoma (ccRCC), according to findings from the phase 3 CheckMate 67T (NCT04810078) study.

The multicenter, randomized, open-label, study compared the pharmacokinetics (PK) and objective response rate (ORR) of subcutaneous vs intravenous (IV) nivolumab administration in patients with locally advanced or metastatic ccRCC who had progressed during or after 1 to 2 prior systemic regimens.

Results presented at the 2024 Genitourinary Cancers Symposium showed that the study met its co-primary PK end points of noninferior time-averaged serum concentration over the first 28 days and minimum serum concentration at steady state with subcutaneous vs IV nivolumab, George reports. The study also met its key powered secondary end point of ORR, with a response rate of 24.2% (95% CI, 19.0%-30.0%) for subcutaneous nivolumab vs 18.2% (95% CI, 13.6%-23.6%) for intravenous nivolumab, he adds.

Safety profiles were similar between the approaches, with no significant safety concerns observed, George continues. Although a higher percentage of patients developed anti-drug antibodies with subcutaneous administration, efficacy, safety, and pharmacokinetic parameters were not impacted. Notably, the median administration time for subcutaneous nivolumab was significantly shorter, at 5 minutes (range, 0-15) or less compared with 30 minutes (range, 6-133) for intravenous administration.

Overall, these data support the use of subcutaneous nivolumab as an alternative administration option to improve healthcare efficiency. This streamlined administration process could greatly reduce treatment burden on patients by allowing for easier access to treatment, George says. Additionally, subcutaneous administration offers the advantage of potentially being administered in remote areas or smaller healthcare settings, bypassing the need for large infusion centers, George concludes.