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Fernando Maluf: So this is my disclosure. And this is the topic to be discussed.

Regarding epidemiology in Latin America, we can see that there are epidemiological differences in the region. There is often inadequate data collection. There is under-notification of cancer diagnosis and mortality. And there are different health care systems in Latin America and also inside Brazil, with limited access to drugs, hospitals, delays in surgery, and a lack of radiation facilities. Because of that, the mortality rate in developing countries compared to developed countries is at least 1.5 to 2 times higher.

Looking at Brazil specifically, 3/4 of the population are linked to the public system called SUS, and 1/4 has a private insurance program. On the other hand, expenditures are delivered mostly to the private sector rather than the public, so in the opposite direction. Regarding high-cost medication, we know that almost 90% of the new drugs launched were consumed in the US, Europe, or Japan.

Looking at Brazil, for many years, no novel agent has been approved for the public system. The last agents were rituximab and trastuzumab for the public. And for prostate cancer, in the advanced disease space, only docetaxel and ADT are available.

So looking at the potential of Brazil and Latin America, I would say that the potential is huge. Brazil has a population of more than 200 million people. It represents the seventh most important oncology market worldwide and the ninth most powerful economy worldwide.

In looking at research specifically, we belong to the LACOG, the Latin American Cooperative Group. LACOG has many institutions affiliated with it. And according to LACOG statistics, there are more than 32,000 new cases per month. And looking at prostate cancer specifically, more than 2,600 new cases per month.

Talking about solutions and projects that not only us but people in the audience—there are a lot of Brazilians here—are looking for and working on together. So the first project is transforming public hospitals that provide only medical assistance in less favorable socioeconomic areas with a high-density population into research clinical units. There is a win-win situation, particularly for the patients.

First, because the patients have the opportunity to be enrolled in top-notch clinical trials that have been ongoing in the best cancer centers in the world. Second, because Brazilian law states that pharma has to pay for everything, so there is saved money for the public system. Third, the patient who enters the trial overcomes the issue of limited drug access. Fourth, we generate jobs and improve the country’s intellectual research. Fifth, we can help in improving the biodiversity, including Brazilian patients in international clinical trials. And last but not least, we develop a health channel with AI to perform a big database looking at patient reward information.

So this is the major project of the institute Vencer o Cancer, called Beat The Cancer Institute. And I have to declare that I'm a co-founder. We have already created six research unit centers in the North and Northeastern part of the country—the poorest areas of the country. One is in the state of Amazonas, one in the state of Pará, one in the state of Maranhão, one in the state of Paraiba, one in the state of Bahia, and one in the state of Mato Grosso.

These are some pictures of the centers that have been created. And at the end of this year, the goal is to have 20 research units throughout the country inside public hospitals that only provide medical assistance. And by the end of 2026, we will have 50 new units. The project can scale up because it's not expensive. We just have to certify the center, and the adequate people in the centers are able, again, to participate—as they are doing right now—in international clinical trials.

Another solution, instead of creating centers, is to make the centers that already exist participate in clinical trials. And one of those that is particularly interesting in our region is to look for innovative treatments for frequent tumors in developing countries. They are rare tumors in developed countries. And this is one of the examples: the HERCULES trial, which has been led by the LACOG team. And we have many investigators here in the APCCC. This trial, supported by MSD, is a phase II, single-arm trial in penile cancer patients—metastatic or recurrent disease—evaluating chemotherapy plus pembrolizumab, followed by pembrolizumab for those who had disease control.

We’re happy to say that this trial for epidemic disease in the country was accepted for oral presentation at the following ASCO. Under the umbrella of HPV-related tumors, we have another trial to be started in the second semester in the same patient population for those who receive platinum-based chemotherapy, randomized between maintenance cemiplimab versus best supportive care in a phase II randomized fashion. And the same for vulvar cancer, which again is epidemic in the country and is very rare in developed countries.

So looking at a different angle of clinical research, the other thing that our group is working on is to promote practice-changing trials of frequent tumors in developed or developing countries, but trials that are only possible to be done because of our unique characteristics of the public system, the SUS. This is a trial that we are going to start next semester called the REDEMPTED trial.

This trial is going in a randomized and non-inferiority design, including muscle invasive bladder cancer eligible for cisplatin, where all patients receive neoadjuvant chemotherapy. And then they will be randomized to answer a certain important question that has never been answered with level one evidence: if chemoradiation is non-inferior to radical cystectomy. And why is this trial possible to be done in such a common disease in Brazil? Because in the public system, most of the patients will undergo radical cystectomy due to a lack of radiation facilities. But in the trial, there will be a 50% chance of having surgery and a 50% chance of having the bladder preserved, and we will see the results on longer follow-up.

So now, changing to promote access to oral oncology medications. This is another project of the Instituto Vencer O Cancer. We wrote a law project to expedite access to oral oncology medications. We built up a national campaign with actors, actresses, singers, TV, and sports personalities. And we’re happy to say that this project was approved by unanimous decision in the Senate. The result is accelerating access to oral oncology medications sixfold for more than 50,000 patients a year.

And last but not least, improving education by consensus for developing countries. We have been inspired by Silke and Aurelius from the APCCC. So we had this consensus for more than 200 physicians from 17 developing countries. And the results were published in seven papers in the Journal of Global Oncology.

So, as a conclusion, clinical research has the potential to overcome the limitation of access to optimal cancer therapies. Health care policies that are able to harmonize the public budget in order to finance the most cost-effective treatments to be delivered to all patients are a reality and need to be done more often. Physician and patient education are key to optimize patient care according to each region’s specific characteristics.

The bad news is that we have many limitations, many obstacles. The good news is that there is a huge room for improvement. And the other good news is that many of the solutions depend exclusively on us. So thank you very much for your attention.