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 CheckMate 9ER, which assessed quality of life outcomes in patients receiving cabozantinib/nivolumab.
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Dr. McGregor: We also have some really nice follow-up now for CheckMate 9ER. We’re starting to get longer trip off of the IO/TKI, cabozantinib/nivolumab. Rana, do you want to talk about that?
Dr. McKay: Yeah, I think we are continuing to see a separation of the curves over time, and the delta between the curves right around 10% separation. That’s really exciting to see that. But I think we’re all looking for durability. That’s the big elephant of the room is are the IO/TKI regimens durable or not?
I think over time, the curves still continue to decline and decline and decline. There isn’t necessarily a plateau, though at least with CheckMate 9ER, what’s been nice is we haven’t actually seen the curves come together, which been nice. They’ve consistently stayed apart, with an absolute difference of around 10%.
There continues to kind of be a decrement. When we look at duration of response from CheckMate 9ER, it’s right around 20 months or so. Comparing it to CheckMate 214, we’re juxtaposing that with the 82. It’s all about durability. But I think IO/TKI absolutely has a role in the frontline. When I’m counseling my patients around this, I tell them do we have to play the short game or do we have the luxury of playing the long game? Most patients actually have the luxury of playing the long game. Most patients are not necessarily presenting in aggressive visceral crisis.
But for those people that are, you can’t afford for them to not respond. You can’t afford for them to grow, I should say. I think that’s where, IO/TKIs can play a real role. We continue to see the solid efficacy data from CheckMate 9ER.
Dr. Tan: When I think about cabozantinib, I think about also the high-risk populations—liver metastasis, bone metastasis. Bone metastasis is about like 20% of the population and so it’s usually a poor prognostic category where patients do worse. What we saw with the CheckMate 9ER update is the PFS hazard ratios are still quite good, it’s like 0.4, 0.5. That’s really good to offer for patients. When I first learned about cabozantinib as a fellow in 2011 was a prostate cancer drug. It currently is being studied, still not to be approved as a prostate cancer drug. It does have really good radiographic bone responses in both disease types.
Dr. Wulff-Burchfield: It’s also encouraging with the CheckMate 9ER data just to continue to see the quality of life data really bears out in a favorable way for patients. We saw at the ASCO annual meeting a few years ago through Checkmate 214 just how clearly quality of life is itself a biomarker, and that is true here, as well. It’s encouraging to see that a regimen that can debulk someone’s cancer up front, in what is sort of a really, I try not to use the word aggressive with my patients, proactive way, an intentional way, still is favorable in terms of their overall well-being. As one of our colleagues was talking about, when looking at quality of life data, it’s important to make sure that we’re seeing that their patient’s disease response is associated with an acceptable quality of life, and we’re not seeing that it’s at the expense of an acceptable quality of life. Here, we’re seeing it more favorable than sunitinib and that’s great to see because I think the idea of it not being inferior to sunitinib is great. It feels like a pretty low benchmark though as someone who has prescribed, who prescribes sunitinib a fair bit in my training. It’s also really encouraging to see that continue to stay consistent in that way.
Dr. McGregor: Absolutely. I think it’s fantastic to see this long-term follow-up for the TKI/IOs. To Alan’s point, we still have benefit. Yes, those with the liver metastasis or bone metastasis may get worse, but they get still get that huge benefit from being proactive with the IO/TKI in that in that space, which I think is critical. I do want to talk a lot about favorable risk with nivolumab/ipilimumab. What are your thoughts? You look at the IMDC risk groups for CheckMate 9ER now with extended follow-up for favorable risk and intermediate/poor.
Dr. McKay: I think when you look at the actual numeric medians for the favorable risk, though I know that you’re not really supposed to, but it’s actually lower in the nivolumab/cabozantinib arm compared to sunitinib, I think 52 or 56. I don’t know if the numbers are spot on, but it’s numerically lower. The hazard ratios continuing to trend upward. I think we’re at 1.1 and change. As the data continues to evolve over time and I commend our partners for continuing to follow patients, it’s not looking as good in those favorable risk patients.
Dr. McGregor: It’s not just this. I think if it was one of them, you would say, okay, but I think we’ve sort of seen across all…
Dr. Wulff-Burchfield: It’s so consistent. The notion that those patients don’t have to be urgently debulked and that the degree of benefit is lower has been a consistent story.
Dr. Tan: A lot of these good-risk patients, that primary progressive disease rate of 20%, I wouldn’t really apply that to that good-risk population because say they don’t respond to ipilimumab/nivolumab 3 months later, they probably wouldn’t have explosive disease right after that. They can go on to IO/TK on after that. The thing about good risk is sometimes we don’t really understand how indolent the cancer is until we’ve had longer follow-up. Maybe these patients don’t even need to be treated at all. Maybe they can get SBRT for a couple of lung nodules.
Dr. Wulff-Burchfield: Speaking of that, there’s some important trials coming up in that way. There’s an ECOG-ACRIN trial called SOAR that’s randomizing patients to either stereotactic radiation to their oligometastatic disease versus standard systemic therapy of investigator choice. Another opportunity to support an investigator-sponsored research within the NCTN.
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