“This will become a very attractive option if approved by the FDA because the treatment burden on patients will be significantly reduced, thus making it easier for patients to access it,” says Saby George, MD, FACP.
In this video, Saby George, MD, FACP, highlights the background and key findings from the study, “Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T,” which was presented at the 2024 ASCO Genitourinary Cancers Symposium in San Francisco, California. George is the director of Network Clinical Trials and a professor of oncology and medicine at Roswell Park Comprehensive Cancer Center, as well as an associate professor at the Jacobs School of Medicine and Biomedical Sciences at the University of Buffalo in Buffalo, New York.
At GU ASCO, the CheckMate 67T, which is a late breaking abstract, was presented this morning. CheckMate 67T is a large, randomized, phase 3, open-label clinical trial testing the noninferiority of subcutaneously administered nivolumab against intravenously administered nivolumab. The pharmacokinetics efficacy and safety data were presented today. As you might know, nivolumab is approved for 22 different indications across multiple cancers. It is approved for intravenous use, while patients find it more attractive to have subcutaneous administration, which is faster, less hassle with the IV port, etc. So, a subcutaneous formulation was developed by combining this with rHuPH20, which reversibly degrades the hyaluronic acid in the extracellular matrix, thus allowing for larger volumes of injection to be done with co-formulation, which is nivolumab in this case.
The study randomized 495 patients in a 1:1 fashion to receive subcutaneous administered nivolumab every 4 weeks or intravenously administered nivolumab every 2 weeks. The co-primary end points of the study were pharmacokinetic end points of Cavgd28 and Cminss. There was also a powered secondary end point of objective response rate in this population, consisting of treatment refractory kidney cancer patients who did not have prior checkpoint inhibitors.
The results showed that the PK end points of Cavgd28 and Cminss reached the threshold for noninferiority for subcutaneous when compared to intravenously administered nivolumab, making this a positive study. Likewise, as a secondary end point of objective response rate was also found to be noninferior for subcutaneously administered nivolumab when compared to IV nivolumab. The response rate in the subcutaneous arm was 24%, and in the IV arm it was 18%. Not much different from each other.
The safety was similar across both the arms. Most importantly, the median administration time for subcutaneously administered nivolumab was 5 minutes, and intravenously administered nivolumab was 30 minutes. There were no safety concerns. There were a higher percentage of patients who developed anti-drug antibodies in the subcutaneously administer arm compared to the IV arm, but that did not amount to any difference in efficacy, safety, or PK parameters. Those are the results.
In summary, CheckMate 67T met its co-primary end points of Cavgd28 and Cminss in terms of PK parameters compared to IV. Also, it met its key powered secondary end point of objective response rate, making it a positive study. This will become a very attractive option if approved by the FDA because the treatment burden on patients will be significantly reduced, thus making it easier for patients to access it. They don't have to go to big infusion centers; [it] can be administered in remote areas where there is no big infusion center. We can have it given in the clinic. So, those are the results.
This transcription has been edited for clarity.