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Pedro Barata: Hi there, I'm Pedro Barata. I'm a GU oncologist at University Hospitals Seidman Cancer Center in Cleveland, Ohio. I'm very, very happy to be joined today by Dr. María Bourlon. She's a rockstar medical oncologist from Instituto Nacional de Ciencias Médicas in Mexico City, Mexico. Fantastic job, María, first of all, in your presentation giving us a fantastic update on the CheckMate 9ER with 55 months of follow-up. You were a top enroller, you did fantastic work with that study for your patients in Mexico, and such a pleasure to have you here today. Maybe I'll start, for those of us in the audience who are not familiar with the study, can you just briefly remind us all what the design of the phase III study was?

María Bourlon: Absolutely. It was a phase III randomized study of cabozantinib plus nivolumab versus sunitinib, which used to be the standard of care in untreated advanced renal cell carcinoma for clear cell histology. This trial already reported primary analysis, and Nivo/Cabo was superior in terms of efficacy endpoints, overall survival, progression-free survival, and overall response rate. It also was better in terms of health-related quality of life compared to sunitinib. So that's what makes this combination therapy a new standard of care for first-line treatment of these patients.

Pedro Barata: Right. That's amazing and you did a fantastic job at ASCO GU, basically showing updated follow-up. It's so important to see how these patients do over time when you combine a TKI with monotherapy in this case, Cabo/Nivo. So important to see what happens over time for a lot of reasons. I'm just going to ask you, because you summarized them so elegantly, so I'm going to ask you if you can do that again. From the efficacy perspective, what are the highlights that you've encountered with these updated results for 9ER?

María Bourlon: Yeah, I think the highlights are we have a long-term follow-up for TKI and IO combination. I think in terms of efficacy, the intention-to-treat population showed that they were benefiting in progression-free survival, overall survival, and overall response rate at 55 months follow-up, which is amazing for a combination therapy. I think the Cabo/Nivo combination provides a very low rate of progressive disease, around 6% versus 13% on the sunitinib arm, so I think, as a clinician, it's very important to see that our first-line therapy has a low probability of having progressive disease.

The other important thing to see is that we have around a 13% complete response rate, which is also very nice to see, the possibility that our patients' cancer will be cleared up. It's really nice. From the quality of life standpoint, I think it's very important to make a remark that from the TKI-IO combinations that we have, Cabo/Nivo is the one that has shown better quality of life in RCC specific tools as The Functional Assessment of Cancer Therapy Kidney Symptom Index, and also, in general, health-related quality of life scores such as the European Quality of Life tools. So I think it's remarkable to see not only efficacy outcomes but quality of life.

Pedro Barata: I agree with you and I have to say, María, that's the experience I have in clinical practice as well. I find a balance. I find a Cabo of 40 milligrams, which was done with a combination with a standard dose of Nivo. And I do find that most patients do well. We have to be aware of immune-related adverse events and obviously TKI-related events. But with that said, that balance, to your point, between the efficacy that you get with the combination along with the tolerability, most patients do well on that combination. That's very remarkable because the goal is so that they remain on that treatment for a long time.

I cannot miss the opportunity to talk to you as an expert in Mexico and a top enroller. You are a clinical trialist. Can you tell us a little bit about how important it is to have representation of diverse populations, minorities, if you will, from South America, in this case, for this trial and other studies in kidney cancer? How do you see that? I know you're doing a lot of work advocating for that in Mexico and also other countries in South America, but can you talk to us a little bit about that?

María Bourlon: Yeah, of course. I think we are aware that tolerability and efficacy of a certain drug can vary among racial subgroups, so it's very important to have racial representation. I think one important fact for the CheckMate 9ER is that we have a lot of Latin American representation, and that's very helpful from a different perspective. One of them is that when we go to the health authorities to get the drug approved, we will have Mexican representation or Latin American representation. So that makes it easier to prove that it's an efficacious drug for our population. And I think that also grants access to our patients. Many of them are in resource-constrained settings and they might not get immunotherapy if it's not because of a clinical trial. So having these trials open in low- to middle-income countries is very, very important, and it also provides us an opportunity to have a safety profile and an efficacy profile in that certain patient groups of different races.

Pedro Barata: Right. Outstanding. This is so remarkable. I couldn't agree with you more. I think the representation of different groups is so important. You can go back to the health authorities and make the case that, indeed, these patients also benefit from therapy. And in the case of the CheckMate 9ER, as you said, that representation was so high and so important to have those patients included.

Listen, congratulations. You did a fantastic job presenting that. Very important results. Looking forward to seeing the data published soon. And congratulations for all the work you're doing advocating for your patients, getting access to novel therapies, including novel trials like 9ER and others. So thank you so much for your contributions and thanks for taking the time to talk to us today.

María Bourlon: Thanks for inviting me to update the CheckMate 9ER study.

Pedro Barata: Thank you.