CheckMate 67T Offers a Look at a Different Treatment Route of Administration

A roundtable discussion, moderated by Brad McGregor, MD, focused on the latest data in RCC treatment and management, including data from the American Society of Clinical Oncology Genitourinary Cancers Symposium 2024. Dr. McGregor was joined by Rana McKay, MD; Elizabeth Wulff-Burchfield, MD; and Alan Tan, MD.

In the next segment of the roundtable series, the panel discussed the impact of a subcutaneous formulation of nivolumab from the CheckMate 67T study.

Watch the next segment in this series.

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Dr. McGregor: Another really interesting trial that may have implications how we treat that line was the subcutaneous nivolumab. We talk about nivolumab, we talk about nivolumab/ipilimumab, we talk about 2 years of intravenous administration. It’s also really interesting changing the route of administration.

Dr. Wulff-Burchfield: I think it’s really interesting. Since COVID-19 has entered all of our lives, a lot of things have changed about the way that we administer treatment, about just the logistics of all of us practicing and the concerns that patients have about more frequent health care contact, legitimately so. The data was very interesting to see, and in that trial patients received either every 2-week intravenous nivolumab or every 4-week subcutaneous nivolumab. I think since that study was designed, most of us have changed over to our patients receiving intravenous nivolumab, receiving every 4-week dosing. However, in that study, the PK data was pretty encouraging to reinforce the idea that this route of administration probably is safe and appropriate.

While certainly we don’t have the same sort of long-term follow-up, and including about efficacy, there were some interesting questions raised about antidrug antibodies. It was encouraging to see that this may be an available option for our patients. Their presentation suggested that the subcutaneous administration was very tolerable for patients, and while I think right now it’s unclear to me exactly what that’s going to look like and who are the ideal patients for that, I practice in the catchment area where I have patients driving really long distances for treatment with me. We’ve implemented telehealth to a great extent. I think that there is a potential future in which perhaps home infusion companies can safely administer this while patients getting labs drawn by them and telehealth with me, which could be really patient-centered.

There’s a lot of increasing data and interest in the concept of time toxicity for patients. Basically, what time patients, especially folks with advanced disease, whose life expectancy, again, we hope is not limited, but currently the thought is that most of their life expectancy is limited, to what it would be without the cancer. Being able to give patients control over their time, where they spend their time home days as opposed to treatment days. For some therapies, for some diseases, there is also data that subcutaneous administration really is impactful, not only for the patient, but for their caregiver or support people.

I remember reading something about subcutaneous therapies. There’s a meta-analysis showing that over the course of several years, patients, caregivers could get back more than 100 days of eligible work days. I think this is really interesting and while I don’t think any of us in this room probably have exactly a roadmap for how we’re going to implement it next, as soon as it’s available, I think it’s great to have more options for our patients.

Dr. McKay: I agree. I think I think ultimately at the end of the day, I think it takes doing a time and cost analysis to see what that’s actually going to look like for patients because is the cost of this medication going to be way more expensive than the time saved? How much do you actually save?

Ensuring that the monitoring that’s currently happening with administration of IV nivolumab continues to happen with the injection. This isn’t just like a LHRH analog that you can give in the clinic without checking labs and just have a nurse just give it in your clinic and go, you still need to check their labs, still need to check their LFTs, maybe their cortisol level, TSH level and ensuring that those checks are still happening, that there isn’t an opportunity to miss an event or something like that, I think is important.

I think the antibody drug antibodies needs to get teased out a little bit. It was around I think around 22% of patients who had antibody drug antibodies. I think that could impact efficacy of the agents. I think we need to understand over time what happens. At the end of the day, it’s a win to have another form of a drug that could be administered, but I think there’s a lot of operational things that need to be discussed and people probably above where we’re at, our nursing team, our pharmacy team, our health systems, to integrate a medication like that in the clinic.

Dr. Tan: Right. I totally agree with all of that. It’s not ready for Monday morning, and of course this was also studied as a single agent and we’re not really using much single-agent nivolumab anymore.

But I’m all for giving patients more time back. If there’s an extended dosing, I’m all for it because patients are anxious. They come into the cancer center and they’re already at the edge of their seat when the doctor walks in. Whether it’s a scan or just opening up labs, patients are anxious and they also want the comfort of their time back.

I will say it wasn’t for me a big differentiating factor because we already have 30-minute infusion. That’s relatively short compared to like gemcitabine/cisplatin, which is like 6 hours. They’ve also had subcutaneous rituximab, which that saves a lot of time when you do it that way, when you compare it to a really long infusion of rituximab.

It’s an option, but it wasn’t a huge game changer for me. We don’t have study it with TKI too. We don’t have it studied as combination either.

Dr. McGregor: I think there’s so many factors. I do think that I commend doing this. We went from 2 to 4 week for nivolumab, or 3 to 6, that was all just on PK. There was actually no efficacy here. We did a prospective study, showed it. We showed that in these patients with refractory renal cell, the PFS didn’t seem to be different. We saw some hints that that we weren’t compromising efficacy, which I think was really an encouraging thing to see with a null agent.

There’s so many factors that come into play. Although I would argue, patients who need to get an infusion, it’s not just the infusion. They have to go get an IV placed or they get a port. Maybe you could avoid putting ports in some patients. I think there’s a lot of other factors. I think it’ll be really interesting to see how we can bring this in the clinic.

Dr. McKay: Absolutely.