The San Raffaele Urologic Oncology Retreat 2022: The International Bladder Cancer Network and The International Bladder Cancer Group - Ashish Kamat

December 30, 2022

Ashish Kamat provides a detailed description of the International Bladder Cancer Network (IBCN) and the International Bladder Cancer Group (IBCG). Despite their common focus on bladder cancer, he outlines their different missions and operational structures. The IBCN, established with a grant from the National Cancer Institute, aims to advance the diagnosis, prevention, and treatment of bladder cancer using markers. It encourages wide participation from professionals interested in bladder cancer, including young researchers, through a broad membership application process. Meanwhile, the IBCG was formed to evaluate existing evidence and trials to inform healthcare agencies worldwide, and membership is by invitation only. Kamat, who has served as the president for both, delves into their historical origins, their focus, member composition, growth, and the key research they've conducted. He highlights their global outreach and collaborations, impact on bladder cancer guidelines, and role in facilitating critical discourse and innovative research in bladder cancer.

Biography:

Ashish Kamat, MD, MBBS, Professor, Department of Urology, Division of Surgery, University of Texas MD Anderson Cancer Center, President, International Bladder Cancer Group (IBCG), Houston, Texas


Read the Full Video Transcript

Ashish Kamat: One of the things that often happens... And it's happened with you, I think, Andrea, as well... is because I've been president of both these organizations, people get them mixed up a little bit. It's the International Bladder Cancer Network and the International Bladder Cancer Group. I'll go through both of these with you highlighting some of the differences, because they're both focused on bladder cancer, and they have the mission to improve the care of bladder cancer patients on a global scale, but the way we do it, and the way the two organizations were founded and are run are a little bit different.

This is first our mission statement. The International Bladder Cancer Network, as I'll go through with you, was actually founded based on a grant that came to the NCI on bladder cancer markers. The mission of the IBCN... The N stands for Networks and marker... it's to improve the diagnosis, prevention, and treatment of bladder cancer through the use of markers.

The International Bladder Cancer Group, which is IBCG, which is kind of tongue in cheek because a lot of our work was done with BCG, so it was IBCG, International Bladder Cancer Group. The goal of that group is to look at the existing evidence, look at the existing trials, and then distill that down in such a way as to where we can inform the healthcare agencies in different parts of the world. We have helped established cancer networks in many parts, Japan, Chile, India. Also, to help the FDA, the EMA, and other regulatory bodies with their endpoints for clinical trial design.

The membership of both is open to anybody that's interested in bladder cancer. So it's urologists, medical oncologists, translational researchers, pathologists, radiation oncologists, statisticians, anyone that's interested in bladder cancer can apply and be considered for membership. Now, that is true of the IBCN more so than the IBCG. Anybody here that wants to apply to become a member of the IBCN can. You send in your application, it's reviewed by our board. Unless there's a red flag, you are usually able to be part of the IBCN. There's a nominal membership to be part of the IBCN. The IBCG, you can send in your application, but that is more by invitation only. I'll explain the differences as to why that occurs. There're no dues for the IBCG because we expect everybody that's part of the organization to put in a lot of effort, and everybody does. So many of you here are members of that, but so there's no dues expected from you to be part of the IBCG.
Just a brief history, the IBCN, like I said, was founded by US-based pathologists and urologists. There was Cote, Cordon-Cardo, and Waldman were the pathologists, and Bart Grossman and Steve Fradet essentially responded to the NCI that had a request for application. That's what RFA stands for, for those that may not know. The RFA from the US government, the NCI was to create a bladder cancer network that could essentially use what we knew at that time to harness the data from bladder cancer markers and create a network. The inaugural meeting was in 1997. Again, it was on diagnostic and prognostic markers. That grant was then fully supported by the NCI. Eventually, that grant ran out in three years, but because of the success of the organization, the IBCN was then formally incorporated in Germany in 2006, and now exists as the IBCN incorporated in Germany.

I've been fortunate enough to be president of IBCN now for almost 12 years. Hopefully, I'll be able to hand it off to someone, Peter Black, hopefully, who's currently our secretary. The IBCG was created by urologists only, initially, but there was a international representation from Europe, North America and Asia to address unmet needs. That unmet need at that time was what to do with BCG. We knew that there was a shortage of BCG that was looming at the surface, what to do, so that's how the IBCG was created. Inaugural meeting again was in 2006, and we wanted to discuss best practices with BCG immunotherapy. At that point, many of you might remember, Sanofi and Merck with the two largest manufacturers of BCG. Sanofi was going to stop manufacturing BCG, and our hope was if you got them involved early, they might not do that. So we had them support the initial meeting, but of course, Sanofi went out of the business of producing BCG for various regulatory reasons. The IBCG now exists independent of the initial meeting. It was incorporated in the US more recently in 2018.
Now let me talk about the two groups a little bit more in detail. These are the current board members of the IBCN. Myself, I'm the US president. Peter Goebell is the Europe president. Of course, we have a Secretary General. You recognize, I'm sure, most of you here Bernd Schmitz-Drager, Steve Williams, Roman Nawroth, Lars Dyrskjot that does a lot of work when it comes to markers in ctDNA, and of course, Tilman is our treasurer elect, so to speak.

The membership has grown. This was the initial small group, this is the next group that met, and this is the most recent meeting that we had, where you can see it's an explosion of the number of members. Like I said, anybody here that's interested and wants to be part of the IBCN can apply. Unless there're red flags, we encourage you to be there, because we are trying to foster young investigators, people that are in early stage of their careers to meet with more seasoned investigators from across the globe, enhance your career. But also, we learn from you. If you have ideas, a lot of these are chalkboard type talks that you give. We are there to help mentor people, grow the network, and essentially improve the penetration of bladder cancer research across the globe.

Speaking of research, the IBCN does have its journal, and we partnered with the SCOO Journal, which is urologic oncology many, many years ago. Michael Droller was one of the original members of IBCN. He's been editor-in-chief of Urologic Oncology since its founding. He just stepped down last year, so we have a partnership with this journal. Multiple publications, I just cut and paste a few of these on there that come out from the group. We encourage all the young investigators to actually have a lead role in the publications. You can see here that most of these, if not all of these, are based on tumor markers, whether it's in diagnosis, in prognosis, or when it comes from our international projects, many of which are again, marker-based, tissue-arrayed, et cetera, et cetera.

Now let me talk a little bit about the International Bladder Cancer Group. Like I said, this group was founded by urologists essentially from across the globe. I'm sure you recognize most of the people here that have a really strong interest in bladder cancer. Professor Maurizio Brausi based out of Italy was part of this. The membership has grown over the years. You can see here we have a large geographic representation. There isn't anybody from Switzerland because I don't think we knew where that country was, but now that we do, we'll correct that thing. Andrea, your picture is not here because you have been delinquent. You haven't sent your picture to us yet, but Andrea's part of this, as well. But again, this is by invitation.

It's experts across the globe and we try to get more people involved that are involved in bladder cancer. As part of the IBCG, we also have a health services research arm. Steve Williams is the director of that research arm. Petros is on that, as well, and again, you recognize many of the faces there. Pat Hensley was a fellow with me last year. He's worked with a few of the people in the audience here, Roberto's over here, and he's gone onto University of Kentucky and he's doing great work there, but he's part of this group, as well.

We do have a lot of publications, as you would expect, from this group. But more importantly, these publications are such that we try to have an impact on the regulatory bodies across the globe. Our IBCG publications have been referenced in the EAU guidelines. They are part of the AUI guidelines. SITC, which is the Society of Immunotherapy for Cancer formally has partnered with us, and it should be out fairly soon. It's the guidelines for anybody that is designing any trial in bladder cancer, whether it's metastatic disease, muscle invasive disease, early stage of disease, or if it's even diagnostic, because we need these white papers. We need these so that the FDA, EMA, the Japanese Association, any regulatory body can actually say, "If you did this study according to A, B, C, D, E, we should grant this drug approval if you meet the benchmarks that are in that paper."

As an example, this was one of the sentinel papers that came out from our group on how to do trials in non-muscle-invasive bladder cancer. Before that, you saw the graphic that showed BCG in 1976, valrubicin in the early '90s, and then nothing until 2020. After this paper was published, and was recognized by the FDA and put forth in the FDA guidance document, there was an explosion of clinical trials, as you all know, in the non-muscle-invasive space. In fact, when I was at the FDA in 2019 December, getting pembrolizumab presented in front of them, a lot of the questions from the FDA were directed towards what the IBCG had recommended and did pembrolizumab meet the benchmark, et cetera, et cetera? Of course, then in January 8th, actually, pembrolizumab was approved for non-music invasive bladder cancer. That's the kind of work that our group tries to do is to help us as a community, create clinical trials, design clinical trials, and then have appropriate benchmarks that if the trial meets, hopefully the drug will then get approved without much hassle.

Of course, we also have recommendations on how to manage common diseases such as low grade bladder cancer. As we all know, there's a lot of overtreatment, and we have tried to come up with consensus documents, which are in a lot of the guidelines, the AUA, and NICE has this adopted, as well. This is a more recent publication. This is on BCG exposed, which as many of you know now, BCG naive, BCG unresponsive, and what do we do with the rest of that. So that's another consensus statement.

This one here, shout out to European Urology Oncology, Wei Shen Tan, who is from the UK and is now in my lab, currently, led this effort on intermediate risk non-muscle-invasive bladder cancer. This is published in EUO, and Alberto informed me and I actually did a social media award to Wei Shen, on the most frequently downloaded and accessed paper in that journal. Hats off to the journal, as well.

Another example of our reach, because we've tried to make this global. When COVID first hit the globe, and of course, Italy was an epicenter, New York was an epicenter, we were trying to figure out how can we harness the known immune protective benefits of BCG? So using our network of the IBCG, this was again a paper that got published later, but this data came out first, and based on this data, actually this trial was developed. Mihai Netea did a lot of the work looking at BCG when it comes to influenza, et cetera, et cetera.
Our work as a group through the IBCG led to the BADASS study, which was BCG as defense against COVID, SARS-CoV-2. This was funded by the Bill Gates Foundation in Australia. In the US, Of course, it's different. It was funded more by smaller groups. In the Netherlands, it was funded by Mihai Netea's group. So a lot of work went on with this. Of course, until we had the definite vaccine available, this was being used in many parts of the world to help boost non-specific immune response to COVID vaccine. We do have an annual forum at the AUA, which is the IBCG AUA forum. So that's the work of the two organizations.

What are some of the opportunities for collaboration for anybody here, or for the center of our group? For the IBCN, we encourage you, as I said earlier, to send in your early stage careers. We encourage chalkboard talks. If you have a clinical trial idea or a drug development idea or even a basic science research idea, it's an excellent opportunity for you to get in front of the experts in the room at a chalkboard level. You get feedback, you take it back to your institution. I have collaborations going on with fellows from all over the globe with me. Then many people from my lab also have mentors that are scattered across the globe.

With the IBCG, we are more consensus based. We try to have meetings that are based on specific needs. For example, if the FDA reaches out to us and says, "We want you to come up with a recommendation for BCG exposed," that led to that publication. SITC, again, Society of Immunotherapy for Cancer has done the same things. We also help with regional cancer guidelines. In South America, for example, in Chile, the Chilean government has asked us to come in and help them with their bladder cancer guidelines. We're having that meeting next year in April. Petros, you are going to be part of that. You don't have the opportunity to say no, you're already on there, and we try to help different governments.

The Echo Foundation is something unique, I'm sure most of you know about it. This is the platform that a medical oncologist, hepatobiliary, and the founder of Zoom, Eric Yuan founded before Zoom was famous. This was in 2014, and it has a global reach of 1.2 billion people right now. It's congressionally funded in the US. It has funding in many different parts of the world. It's not for cancer yet. It's used more for other diseases. It's used for liver disease, tuberculosis, a lot of different things. We and other groups are using the Echo platform now for the oncology site to have a global reach.

It's not telemedicine, it's more tele-mentoring. So if I want to take you, Noel, and echo you, that's what it means. So we'll take your expertise and echo you, you get multiplied 5, 25, 125 times over. Anybody here that has an idea that you think is unique to you, it's your talent, it's your idea that you would like to see echoed in different parts of the world, we do the cancer part of it. If you are interested, just let me know and we can get you hooked up with those.

Some of the other things are collaborative projects, studies. For example, we have registries that you can participate in, harness the collaborative experience across the globe. We have tissue micro arrays, and an incubator really for different ideas and different assays. Artificial intelligence based on slides they can upload, many, many opportunities which I didn't want to list here in the interest of time. So with that, I want to, again, thank you for the invitation, and thank you for your attention.