Pembrolizumab in Combination with Lenvatinib as First-Line Treatment for Non Clear Cell Renal Cell Carcinoma (nccRCC), KEYNOTE-B61

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Pedro Barata: Hello and welcome. My name is Pedro Barata. I am a Medical Oncologist at GU and Associate Professor of Medicine at Tulane Medical School in New Orleans, Louisiana. It is a real pleasure for me to be presented today by Dr. Laurence Albiges to be accompanied. She is really well known and a star in the renal clinical arena. She is an MD/PhD Medical Oncologist and currently Head of the Department of Medical Oncology at Gustave Roussy in Villejuif, France. So welcome dr. Albige. Thank you for taking the time to be with us today.

Laurence Albiges: Thanks Pedro Thanks for the invitation.

Pedro Barata: Absolutely. By the way, I’ll start by congratulating you on your fantastic talk and the presentation of a very important study, your phase 2 keynote B61, which is basically investigating the combination of lenvatinib with pembrolizumab as a first-line treatment for patients with non-clear cell renal cell carcinoma. So again, very elegant presentation and I was hoping we could talk a little bit about that today, if that’s ok with you.

Laurence Albiges: Secure. It will be my pleasure. So this is actually a phase 2 in an area that is clearly an unmet need. Namely what we call non-clear cell renal cell carcinoma which should not be labeled as such as they are other entities that usually have a worse prognosis than clear cell and are really difficult to treat. So what we’re reporting this time, and it’s the first time we’re presenting the data, is a phase 2, a non-randomized phase 2 that enrolls patients with non-clear cell histology who have never been treated before and who have a combination pembrolizumab given every six weeks with lenvatinib 20 mg per day. So it’s a combination of VEGF TKI, lenvatinib and the immune checkpoint pembrolizumab. The primary endpoint of this study is response rate.

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Pedro Barata: Fantastic. Thank you very much. So remind us how you said you’re making a very, very good point, right? Unclear cells behave differently than clear cells. And we can actually go further and argue that there are actually many different diseases within the non-clear cell group that are part of this broad classification of non-clear cells. Can you remind us what kind of patients were enrolled in this phase two as far as histology goes and then also go ahead and give us the highlights of the efficacy part of this study if you will.

Laurence Albiges: Secure. This study is therefore a study with 150 patients. What was presented at this ESMO are the very first results with an efficacy population of 82 patients. These were patients for whom we had adequate follow-up care. And regarding your question about histology, the vast majority of these patients are papillary nccRCC carcinomas. They account for 51 patients in the efficacy population. So that’s about 62% of the patients. The second most common entity is what we call chromophobia RCC and we know these patients are difficult to treat because they tend to be less sensitive or less responsive to an immune checkpoint when used as monotherapy. And then we had other histologies like translocation RCC or unclassified tumors or even rarer tumors like medullary carcinoma. So, as you can see, these are very [inaudible] patient population.

Laurence Albiges: What are the key results? Well, first the response rate, which reaches 47.6%. So almost every second patient has an objective response. The disease control rate is 79%. So basically, almost 80% of patients have either a partial response or stable disease or even a complete response. And if you look at the reaction by histology [inaudible], it is very consistent across papillary and classified translocations and other tumor types. The histology, in which we saw that the tumor was chromophobic as expected, was less appealing. And I think it’s important to emphasize here that we already had single-agent pembrolizumab data that was previously reported by David McDermot. We had seen other regimens in combination with VEGF-TKIs and this is the first report of lenvatinib plus pembrolizumab in this histology of patients with unclear cells. There was no significant signal in terms of safety. This is the regime we are used to.

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Laurence Albiges: So there was no new safety signal. I think it’s important that of the 82 patients who were amenable to a response, we were able to see some tumor shrinkage in the vast majority of them. 86% of patients had some degree of tumor shrinkage. So clear, a combination that is active, because now the follow-up is short. We only had 8.2 months of follow-up. However, many patients were still being treated at the time of the analysis. Therefore, we await further follow-up and follow-up of the entire patient population to provide a definitive analysis.

Pedro Barata: No, it is so important how you mentioned and summarized these results. In my opinion, this is very good news as it promises promising results for patients with non-clear cell histologies. And so thank you for highlighting it so elegantly for us. And as you said, now we have data with lenvatinib, pembrolizumab. There are other combinations being explored with proof of concept and promising results. Can you tell us what the next steps in this effort appear to be? I mean it sounds like you’re going to update with longer, more mature follow-up, you’re going to update those results and hopefully we’ll see that the data is consistent over time. Are there any other perspectives you can share with the audience regarding the next steps for patients with non-clear cell RCC?

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Laurence Albiges: Yes. Many Thanks. So what I can’t tell you yet is progression-free survival as the median follow-up is currently 8.2 months. What we have at six months is 72.3% of the patients who are progression free at this point. So we haven’t reached mean PFS yet. And of course we don’t have the overall survival for this patient population yet. I think these articles are very important. As previously mentioned, these patients tend to have a poor prognosis. It is therefore very important to be able to generate prospective data for combination therapies in this area. So we eagerly await these longer-term follow-ups to define the potential role of this combination in patients with non-clear cells.

Pedro Barata: This is fantastic. well dr Albiges, I have a feeling we could stay and talk about this much longer. I really appreciate you taking the time to talk to us. Again, congratulations. Very elegant presentation and looking forward to the actual follow up dates as well as the release right? So thanks again and congratulations.

Laurence Albiges: Many Thanks.

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