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Yohann Loriot: Thank you, Andrea for this invitation to the speed dating. So I will try to give you a overview of the work conducted by the GETUG.

I provide here a subtitle. So is there still a room for academic clinical research? When you did your review on the past 10 years in bladder cancer, I think you mentioned only one academic trial. So I think it's still a relevant question for us as academic researchers.
Clinical research in France in GU oncology, mainly conducted by the GETUG, which is a network with 60 centers and more than 100 active investigators. We have one infrastructure to conduct a trial which is Unicancer. It's a main sponsor for clinical trial and the funding for us comes from the Ministry of Research charities. We have two good charities in France and of course industry and we try to collaborate with other group like SOGUG, EORTC, SAKK and other group in Europe.

So the structure of GETUG, basically it's a multidisciplinary group with mainly medical oncologists and radiation oncologists, but also urologists from the French Association of Urologists and pathologists of course, statisticians and also radiologists. So it's open to all, I mean investigators from the public practice and the private practice as well.

We have a steering committee elected every five years with the chair and the current chair is Karim Fizazi. We tried to conduct clinical trial in the five different tumors including the rare tumors and penile tumors.

So GETUG was founded 30 years ago and as you can see here, there is steering community with medical oncologists, radiation oncologists, biologists, urologists and statisticians. We have a lot of trials, a lot, and half the trial are actually sponsored by Unicancer and half the trial are sponsored by other structures like university hospitals or comprehensive cancer centers. Of course, to do that we need to collaborate and we collaborate a lot with the pharma companies as you can see here that funded the majority of our trial.

As I said before, we try to collaborate with a lot of different international partners. You can see on the map that we collaborate mainly in Europe to conduct clinical trials, but also other group worldwide to share data that we can generate to conduct for example meta analysis.
So what is the GETUG perspective for clinical trial? What is basically the strategy? The first, we try to develop practice-changing phase three trials that could have an impact, true impact on the management of the patient. In this perspective, we try to develop a very easy trial to implement so it's a pragmatic trial.

Important enough we have to conduct trials in rare tumors, that's our missions. Also, we try to leverage the data that was generated in the past for example, to conduct meta analysis.

So here's an example of the recent and ongoing trial. You can see here that the majority of the trials focus on prostate cancer, but we try also now to conduct a trial in bladder, in kidney cancer and still in testical cancer and we try in penile tumors.

So some examples of the phase two trials and pragmatic trials that we're trying to conduct. So historically, we conducted trials in prostate cancer, in metastatic prostate cancer and localized prostate cancers. So you can see here a list of different trials that address very simple questions, dose of radiation, combinations. We were quite successful in the past and now we try to expand in other tumors like in bladder cancer with the recent reported trial, the VESPER trial that we reported this year. Also, in kidney cancer with a very straightforward trial, the CARMENA trial that we reported four years ago.

So the lesson that we got from this experience is that if we can collaborate between urologists, medical oncologists, we can do very important trials. So it's very critical that our group try to attract young investigators from the different specialties. Also, I think one important but very simple message in frequent situation means accrual creates a successful trial.

Another aspect is to try to conduct trials in rare tumor as again it's very difficult and is not the interest of the pharma to conduct a trial in rare tumors, so that's our mission. So historically, again we conducted a trial in metastatic testicular cancer with the GETUG 13 trial that Karim reported a couple of years ago now.

We expand next with our experience in incorporating the PET scan in the management of patient with metastatic seminoma that we reported this year. Again, the important message here is that rare situations are challenging of course. GETUG 13 took more than 10 years to accrue the 200 patient needed to address the questions. To do that, I think centralization of care is critical of course in rare tumors.
But recently, what we try to do on top of phase three trial and pragmatic trial is to try to develop proven conceptual trial based on biology. So here some example, one in bladder cancer with the neoadjuvant pembrolizumab trial in bladder cancer. So the design was very, very similar to the PURE trial. Patient were treated with pembro before cystectomy, but the question here were mainly to address the mechanism of pembrolizumab in this situation. Basically, what was shown is that the entrapped tumor infections by bacteria activate immune system and this is associated with better response to pembrolizumab.

Another example in kidney cancer with the BIONIKK trial, which was I would say a precision medicine trial, that addressed the question of the utility of the gene expression classification in kidney cancer. This experience was recently again reported by Yann Vano in Lancet Oncology.

Another aspect from our group is to try to leverage the data that we generate in the old clinical trial that's been data-sharing. And like many other group, we try to share the data from for example GETUG 15 or the GETUG 12 in the ASCAP project. Another example, the metaanalysis, the artistic metaanalysis and we provide some data from the trials that were conducted in the past here, an example with the GETUG 17 trial.

Again some other examples with collaboration with UCL or with American colleagues here for other metaanalysis.

So what is working in the GETUG? I think the accrual clearly works and the collaboration between urologists, radiation oncologists, medical oncologists. I think we can provide good trials in a rare situation, a rare tumors and we're trying now to address different question in all stage of the disease. So in early setting, in late stage I think it's works.

What is not working, I think trial with complex processes and infrastructures. It's quite different from STAMPEDE experience for us. Also, the time to implement the trial in the context of rapid changing landscape, for example in kidney cancer or in bladder cancer.

Also, in our experience, you can have a very good trial, very good idea. So you can develop a trial, but if not all investigatorS are convinced by the idea, it's A crash. Here an example with the GETUG 12. So basically, this trial addressed the question of adjuvant hormonal therapy after prostatectomy. Very straightforward trial and actually not all investigatorS were convinced by the question. As you can see here, the accrual was quite poor and we have to stop the trial recently.

So one of the most important issueS for us in academic settings is to try to accrue patient quite rapidly. A large number of patients in the future are likely to be needed to address important questions. So in phase three trials and probably national groups are unlikely to do it maybe except UK. So we need for pragmatic transnational system to be able to conduct such large trials.

So Silke, discussed a bit about the PEACE program so that rationale, this a consortium in Europe on prostate cancer. The principle basically, is to conduct academic European trial, phase three trial in prostate. So sponsor could be any academic group, an hospital, university.

The budget is provided for trial by trial and there are clear publication rules to make it possible that many investigators are committed to a role in the trial. So this led to a position paper reported by Bertrand Tombal and Karim Fizazi and the first experience was the PEACE 1 trial that was reported last year and published. So as you can see here, PEACE 1 was conducted in many countries in Europe and clearly it was successful. We can accrue rapidly the patients needed to address the questions and finally we were able to report the data very, very, very fast.

So we have now many other trial conducting in this consortium like the PEACE 2 that completed the accrual. Again, here an example of the collaboration between France, Belgian, Spain, Italy. The PEACE 3, the sponsor is EORTC, but France is participating to the trial. PEACE 4 and now we have eight trial conducted by the PEACE consortium.

We try to expand this experience in other tumors. Here, an example in bladder cancer with the ALBAN trial that I'm pleased to conduct with my friend Morgan Roupret. The question is very straightforward, BCG versus BCG plus atezolizumab in high-risk, non-muscle invasive bladder cancer. So we conducted initially, the trial in France and then we tried to expand in Germany, Belgium and Spain. Germany declined and was not selected due to too many unknown situations earlier. So we conducted the trial in France, in Spain and in Belgium. But basically we follow the example of the PEACE consortium.

So the visions we can have from the academic clinical research. I think the main goal of academic research is to test new ideas and concepts. To do that we have to conduct fast trials at reduced cost without too much bureaucracy. The drug development clearly is conducted by the pharma, is sponsored by the pharma, which is critical of course for the patient.

But new strategies, combinations or exploration of different patient populations like patients with rare tumors clearly is the mission of academic trials. To me, the academic research is the way to develop the creativity and especially the creativity from young investigators. So I know that a lot of young investigators are disappointed by academic research, because it's a long time, very difficult, many hurdles, but we have had senior investigators to address these questions. We have to prove that academic research is important in oncology.

The main problem I think it's not new. Of course, it's the bureaucracy. There are three components of this bureaucracy. The first is data security that lead at least in Europe, in over regulations resulting in reduction in research. So the complexity of the trials and the need to collect so many items, so much data, there is some surveys that show that we use only 10% of the data in the service of a clinical trial. So the unnecessary data capture, the quality of control is a problem and the associated overwhelming role of CROs and the increasing cost.

Also, we try to collaborate that probably the discussion we will have, but the data and sample sharing is quite difficult, because there is too many administrative delays between two different institutions, so many signatures and validations. We discussed during the break with Andrea how many signature you need sometime to provide to collaborate so that's a problem we should address.

Thank you for your attention and thank you for Soazig Nenan from Unicancer for giving me some figures and Karim for some slides.

Thank you.