From Infusion to Injection: The Promise of Subcutaneous Nivolumab

At the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, a roundtable of expert panelists convened to discuss the latest research and practice updates related to advanced kidney cancer. Dr. Karine Tawagi of University of Illinois was joined by Drs. Regina Barragan-Carrillo, Benjamin Maughan, Laurence Albiges, and David McDermott in the discussion.

In the fourth part of the roundtable, the panel explains how the FDA approval of subcutaneous nivolumab offers significant advantages in patient convenience and healthcare efficiency, with trials confirming its non-inferiority to IV administration in both pharmacokinetics and clinical outcomes, reducing infusion times to five minutes, easing hospital burdens, and potentially paving the way for future at-home administration.

View the next segment on Multidisciplinary Approaches to Managing IRAEs in RCC.

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Dr. Tawagi: We know that there has been a recent FDA approval for subcutaneous nivolumab. Does anyone here have experience using it? What are your thoughts?

Dr. Albiges: I led the registration trial comparing subcutaneous nivolumab to intravenous nivolumab. This was the CheckMate 67T trial. It was very interesting to conduct this trial because, while it may seem insignificant, it is a major development for patients and the healthcare system. The ability to administer a drug in five minutes with a fixed dose—walk in, walk out—versus an intravenous infusion that takes 30 minutes is extremely important for scheduling infusion rooms and improving patient quality of life.

The study was designed with a primary pharmacokinetic endpoint but was also powered to evaluate clinical endpoints, including response rates. It focused on second- or third-line treatment for patients with RCC, and the results have been published in Annals of Oncology. This registration trial demonstrates the non-inferiority of subcutaneous administration in terms of PK endpoints and clinical outcomes.

Interestingly, the exposure with subcutaneous administration was slightly higher, and response rates were a few percentage points higher as well. Progression-free survival was also slightly longer with subcutaneous nivolumab. I believe this trial serves as proof of concept that in oncology, we want to move from intravenous to subcutaneous administration. This transition happened with HER-2 targeting drugs, and now it is occurring with immune checkpoint inhibitors. Atezolizumab was the first PD-L1 inhibitor to receive subcutaneous approval, and now nivolumab is the first PD-1 inhibitor approved for subcutaneous use as of December. It is worth noting that the approval is not limited to RCC; it is broad, allowing the agent to be used in combination with chemotherapy or VEGF targeting agents. We discussed CARBO-NIVO and the use of nivolumab in maintenance after nivolumab-ipilimumab combinations, which can now be administered via the subcutaneous route.

I am very pleased about this development because I believe it opens new opportunities for patients and reduces the time they spend in the hospital. It also makes the treatment process more patient-friendly, which will help in managing healthcare resources more effectively.

Dr. Tawagi: Absolutely. There is a huge quality of life benefit to spending less time in an infusion chair. Does anyone else have the availability of subcutaneous nivolumab in their institutions?

Dr. McDermott: It is currently under review at our institution. We are not typically involved in the decision-making process; it is usually handled by the pharmacy team or nursing. My guess is it will be approved for the reasons mentioned. We have a shortage of treatment nurses, so this approval would allow us to treat more patients in a day and could have a broader impact across multiple tumor types. Anything that helps us treat more patients is likely to get approval, but it has not been approved yet.

Dr. Tawagi: I definitely agree. Staffing shortages are an issue, and this will help alleviate some of that burden.

Dr. Maughan: Our institution is in the same situation. It has not been approved yet, but I expect it will be, as infusion centers are typically overbooked, and this could help ease that pressure. I keep dreaming that the next press release will announce self-administered nivolumab. That would be the ultimate convenience and would be wonderful for patients.

I am so grateful that researchers like Dr. Albiges have put in the effort to conduct this trial, as the convenience of administration is so important for patient quality of life. In our region, it is common for patients to drive three, four, or even five hours just to get to the infusion room. If they could self-administer the medication at home, that would be a tremendous advantage. But even reducing the time spent in the infusion center is a great first step. I hope that BMS takes this a step further in the future.

Dr. Albiges: I can give you an example from France, where we have already implemented nurse-administered home administration for PD-1 inhibitors.

Dr. Tawagi: That is wonderful. That is definitely the future.

Dr. Albiges: I think it is very convenient.

Dr. Tawagi: As someone who was involved in the trial, did you observe any differences in toxicity profiles between the subcutaneous and intravenous formulations?

Dr. Albiges: That is an excellent question. There are two aspects to consider. First, there was no increase in immune-mediated toxicity; no new safety signals compared to the intravenous formulation. Second, regarding local administration, there were some low-grade reactions at the injection site, but these were only grade one or two and resolved on their own. These reactions did not lead to any treatment discontinuation, which is very encouraging. The safety profile for both local administration and immune-mediated toxicity remained the same as with the intravenous formulation.

That being said, we monitored for antibody drug reactions (ADA), and while there were slightly more ADAs with the subcutaneous formulation, there was no associated difference in activity or toxicity.

Dr. Tawagi: It is reassuring to hear that the toxicity profiles are still comparable to the intravenous formulation. Dr. Barragan-Carrillo, do you have any experience with subcutaneous nivolumab?

Dr. Barragan-Carrillo: Not yet. We are in the same situation, where it is under review. However, having trained abroad in Latin America, I believe this is a major step forward in global oncology. As you mentioned, many patients have to travel long distances—sometimes up to five hours—just to get to an infusion center. The ability to reduce that time to only five minutes for an injection and then send the patient home to focus on their daily life is a huge improvement. These efforts are very important, and I am excited to see these changes being made.