It is a very important component of this particular study. Exactly to your point, when you’re dealing with cancers that are this rare and afflict predominantly underserved populations, it is not easy to conduct trials and research. We have been able to activate dedicated clinical trials for RMC. In fact, our fifth such trial was just activated at MD Anderson this month...
It is a very important component of this particular study. Exactly to your point, when you’re dealing with cancers that are this rare and afflict predominantly underserved populations, it is not easy to conduct trials and research. We have been able to activate dedicated clinical trials for RMC. In fact, our fifth such trial was just activated at MD Anderson this month. However, we have to be strategic. When you’re dealing with such rare and aggressive diseases, you have to pick and choose whether you will invest the time, effort, and resources to open formal clinical trials. And you will want to do that when you want to use novel drugs, drugs that are not otherwise available in the market. And that is exactly what we’re doing in our clinical trials in RMC. And when these novel agents work, that’s great. When they do not work, we learn. We refute our hypothesis and keep moving the field forward. Conversely, for therapies like the panitumumab-based therapy that I’m presenting at ASCO this year that are readily available, this is a drug that has been available in oncology for decades, and so is its combination with paclitaxel, Abraxane. What we did is we repurposed the drug, and one of the things that we found is that both in the U.S. and other countries like Canada, Europe, Germany, for this particular study, and now we know South America and many other countries, there are ways to justify and repurpose available drugs for patients. So once you do that, what you need to do is have a coordinated system, which we did, to prospectively gather the data across the world and make sure that the quality of the data is high. That’s a key thing. That is the big difference between observational non-registered studies and let’s say a formal clinical trial that is single arm. It’s the quality of the data. So we put a lot of effort into having high-quality convincing data and this is a strategy that can be scaled up both for not only RMC but other rare kidney cancers that do not have dedicated options the way now RMC does. For example, translocation renal cell carcinoma, chromophobe renal cell carcinoma can take advantage of this and other cancers and not just other rare kidney cancers but other rare cancers in general.
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