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Medicine Matters oncology

Thank you for having me here today to discuss the results of the 9ER trial presented at ESMO. This study is a combination of cabozantinib and nivolumab versus sunitinib in the first-line treatment of advanced renal cell carcinoma. And the findings were remarkable. There was an improvement in progression-free survival of 16.6 months versus 8.3 months with the sunitinib, so a doubling of the progression-free survival with the combination of cabo-nivo versus sunitinib. So this is pretty remarkable.

And in terms of other findings was that the overall survival, there was a 40% reduction in the risk of death with the combination of cabo-nivo versus sunitinib. And the overall response rate was also improved.

So I would say that this combination of cabo-nivo is very active. And it is in line with the findings that we have of pembrolizumab and axitinib in combination in the first-line setting for patients with renal cell carcinoma. And what was also remarkable was that there was improvement in outcomes in all the IMDC risk scores, so favorable risk score, intermediate, and poor risk all benefited from the combination of cabo-nivo.

I think it becomes very difficult now to choose between your treatment options. You really have to look at the burden of disease of the patient. How quickly do you want to achieve a response? Looking at the CR rates, the Complete Response rates of the combination of cabo-nivo was very good. It was 8%. And nivo and ipi was 9% and 11%, 9% to 11%.

So these things that-- these are the things that we need to think about when we're thinking about treatment options for the patients, but the take-home message is that this combination is very active. It's the best hazard ratio that we've seen in terms of the progression-free survival outcome compared to sunitinib.

And we need longer follow-up. So far, the follow-up we have is about 18 months, which is very good, but I think longer follow-up will tell us a little bit about the survival, but the survival is a little bit tricky because a lot of these patients go on to receive subsequent therapy. So it is really hard to interpret the survival benefit, but there is definitely a great progression-free survival benefit. And the overall response rate and the CR rate are terrific.

So I don't think that we're going to have a trial where we can compare cabo-nivo with axitinib-pembrolizumab or other combinations. I think that that's going to be very difficult to do. There is an ongoing trial right now asking the question of cabo-nivo versus cabo-nivo-ipi. And that's going to be a really important question to ask.

There's also a trial that's ongoing right now called the PDIGREE trial. And that trial is very nice because what it does is it starts everybody, all the patients with metastatic renal cell carcinoma, in the front-line setting, and they start with cabo-nivo. And really, based on their response, they get different treatment.

So, if they have a complete response, then the cabo is stopped, and they go on just to nivo. If they have a partial response, then they would get randomized to nivo versus cabo-nivo. And, if they progress, they get cabo. So this is a really important trial that is currently being run through the Alliance cooperative group.