My name is Guillermo de Velasco. I'm a medical oncologist from the Hospital 12 de Octubre in Madrid, Spain. So today I will be discussing four abstracts presented at ESMO in kidney cancer and about immunotherapy. So the first one is about the ADAPTeR trial, which is a trial where patients are receiving nivolumab neoadjuvant prior cytoreductive nephrectomy. And this is amazing because it's the first time we're having data about that.
And the first thing we've seen is that there's not new safety concerns, which is pretty good. And the other thing is that the authors are putting in context because they are taking many samples for each patient as a baseline. And we are seeing that the same patients may have a cold immune infiltration, but also a hot immune infiltration, which makes really, really difficult to understand which patients may respond to immunotherapy with these type of signatures.
The second abstract that I am discussing is about post-hoc analysis of the JAVELIN Renal 101. Just a brief reminder for you, this is a trial where axitinib plus nivolumab show to increase the PFS and the response rate compared with sunitinib.
So in this post-hoc analysis, they are looking specifically for those patients who did not have upfront cytoreductive nephrectomy. What is striking is that these patients had a really good response with combinations with axi plus avelu and more than 35% of the patients had a tumor shrinkage of more than 30%. Compared with those patients with the old drugs such as sunitinib, then we know that it's about 10% or less than 10%.
So now they look at specifically what happened with those patients without upfront cytoreductive nephrectomy. So they found a couple of things. First is that the PD-L1 expression in those tumors was quite low. And those tumors will-- they were a little bit of heterogeneous compared with the others. So why? They don't really know, but they look specifically for some gene signatures.
And they found that patients with high CD8 signatures, they had better respond with a combination with axi plus avelu. They also look at previous signature published, such as the one from the IMmotion 150 signatures, and they found that that signature predict response for the combinations, although the angio signature did response to sunitinib.
And strikingly, in this sub analysis, in this subset of patients, those without upfront cytoreductive nephrectomy, the JAVELIN Renal 101 signatures did not predict PFS in either arm.
So the third abstract that I'm discussing today's is another sub analysis of the same trial, the Renal 101. And in this one, they are looking specifically for the sarcomatoid histology. So we know that sarcomatoid histology is usually associated with poor outcomes. And we know-- we've seen recently some data that the new checkpoint block, it may have an impact in these patients. So in this study, they looked specifically for their patients from the JAVELIN 101 with sarcomatoid differentiation.
So the first thing that they found is that the combination with axi/avelu improve the PFS compared with sunitinib with a hazard ratio of 0.5, which is quite impressive. And the 12 months overall survival, it's more than 80%. What I think is important, it's like, if we put in context with all previous data from sarcomatoid RCC, around 10% of the patients with IMDC good characteristics are sarcomatoid, which is striking because we'll see some patients with good prognoses and also sarcomatoid differentiations.
Also, the PD-L1 expression is higher compared with the overall populations. Regarding the outcomes, are pretty good. And if we look at the response rate and the overall response rate in this specific sacromatoid population, it's higher than you would expect for our patients with worse outcomes. So the question, what's going on? Why this is better?
So they have to study different signatures as well in these sarcomatoid populations. And what they're seeing is that you can have more immune suppressive elements upregulated, such as the T gene regulation cluster, or the CDH, or the CAF cluster. So that's maybe the reason why they have good prognoses, and maybe with these combinations you can overcome the aggressiveness on this type of RCC.
And the last abstract that I'm discussing today is the NIVOREN GETUG AFU 26. This trial was conducted in France, and they included more than 700 patients with kidney cancers treated with nivolumab. And that was real world data. And the interesting thing in this part of the presentation, they are showing the analysis of the CD8 and PD1 infiltration in the 300 patients with available samples.
So they look the CD8 not only in density, and they did a score between 0 and 3, and they put also in context where was located those CD8s. Either in the core tumor or in the invasive margin. And what they found is that the CD8 in the tumor margin may be associated with poor outcomes. However, the core tumor did not have any association with overall survival or PFS.
They also look at the PDL1 expression, in the immune cell, and in the tumor cell. And they did not find any difference with the immune cell. However, in the tumor cells maybe associated with worse OS, although they didn't find any difference in PFS.
I think in this context, if you look at this all four abstracts, they are looking for biomarkers to understand better how is the-- how can we treat better our patients with these different combinations? And I think if we look at the landscape of RCC, we are seeing many drugs. However, there is no single biomarker. It's not like lung cancer, you have your four or breast cancer you have your two. We don't have any.
Although if you look at the guidelines today, we are dividing our patients in favorable or intermediate and poor-risk patients based on the IMDC. So I think we should put always the IMDC and the treatment landscape because that's really what it's now helping us to decide our treatment.
And also about sarcomatoid differentiation, I just want to point out that the guidelines don't say our recommendation for these specific population now. I think that may change because there are 10% of the patients with a IMDC good prognosis with sarcomatoid differentiation that may need to have a double combinations, and that may be a good recommendation for these patients.