Camillo Porta, MD, offers key takeaways from CheckMate 9ER trial in renal cell carcinoma

In this interview, Camillo Porta, MD, shares in-depth insights on results from the study, “Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Final follow-up results from the CheckMate 9ER trial.” These data were presented at the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, California. Porta is the chair of oncology at the University of Bari ‘A. Moro in Italy.

This transcript was AI generated and edited by human editors for clarity.

Camillo Porta, MD

Could you describe the background/rationale for this trial?

We know that kidney cancer heavily relies on angiogenesis, but we know also that it is a very immunogenic tumor, so it was almost natural to combine an immune checkpoint inhibitor with an anti-angiogenic agent. The combination of nivolumab plus cabozantinib already [showed improvement in] both overall survival as well as progression-free survival in metastatic kidney cancer patients treated in a first-line setting. In San Francisco, we presented the final update of the CheckMate 9ER study of nivo/cabo vs sunitinib, which was the standard of care for metastatic kidney cancer at the time of study design.

What were the final results that were presented at ASCO GU?

At ASCO GU, we presented the final analysis of the study, which confirmed the superiority of a combination over the TKI monotherapy in terms of both progression-free survival as well as overall survival. Progression-free survival was 16.4 months with the combination, as compared with less than 9 months with sunitinib monotherapy.

But more importantly, the benefit we observed was also evident in overall survival, which remains the most important study end point for us as oncologists. In terms of absolute values, the median overall survival for the nivo/cabo combination was 46.5 months as compared with less than 36 months for sunitinib monotherapy. As already shown in the primary analysis of the study that was published on The New England Journal of Medicine, this difference could be statistically significant.

How should urologists interpret these findings?

Given these results—which also showed a high anti-tumor activity of the combination with a 13.9% complete response rate, which is really striking—it is clear that for both urologists and oncologists, the nivo/cabo combination represents one of the standards of care for the present treatment of metastatic kidney cancer in a first-line setting. It is a highly active and efficacious treatment that compares with all the other available options we do have, and are suggested by both the EAU [European Association of Urology] and NCCN [National Comprehensive Cancer Network] guidelines and so on. This is one of the best options we have to treat metastatic kidney cancer with the ultimate aim of prolonging survival.

What unanswered questions remain regarding immunotherapy and targeted therapy combinations in renal cell carcinoma?

We still have several questions unanswered. The first one is what to do in the case of progression under these treatments, which is still not so well known. We know that sequencing immunotherapy does not make sense after the failure of previous immunotherapy given either alone or in combination with an anti-angiogenic agent. This is a first major issue that we still have to solve.

The second point is that we are selecting a small fraction of patients who, despite having metastatic disease—which has been until now, considered as incurable—probably are cured by use of these combinations. But still, we are not able to select a priori, which of our patients will benefit most from these treatments. This relates strictly with the third topic that still has to be clarified, which is the lack of available biomarkers, which still affects our treatment choices.

Taking all of these findings together, what are the key takeaways for urologists?

The first takeaway is if you need a highly active and efficacy treatment, nivo/cabo is one of the available options. We do not have strict criteria in order to differentiate this treatment from the other 3 available combinations, which prove to positively impact overall survival.

I would conclude with the words by Tom Powles, who said that "you have to pick your choice and keep it." That means trying to optimize the treatment in order to maintain the patient as much as possible on treatment, which ultimately means an adequate management of treatment-related adverse events, which presently represents the major issue for us as oncologists in this field.

Is there anything else that you wanted to add?

We have improved a lot in the field of metastatic kidney cancer, but we still need to answer a lot of questions [regarding] biomarkers, sequencing, [and] optimizing treatment, which is sometimes difficult due to the clear side effect profile of these treatments. Ultimately, [the goal is] paving the way for the development of more active treatments that will select a larger amount of patients [for cure].