Precision medicine has emerged as a new hope for cancer patients who have not gotten better with existing therapies. Precision medicine refers to personalized medical service that customizes treatments by analyzing the individual’s genetic information, medical history, and lifestyle. It makes treatments more efficient and lowers side effects.

The Ministry of Health and Welfare and the Ministry of Science and ICT will invest 63.1 billion won in a precision medicine project group for five years by 2021. As an initial step, the project group will focus on diagnosing and treating cancer and developing a hospital information system for precision medicine.

The project group has two subgroups – K-Master for development of precision medicine-based diagnosis and treatments, and P-HIS (Pharmaceutical Health Information System) for developing a precision medicine-based health information system. Korea University Anam Hospital has been selected to lead the two subgroups.

Kim Yeul-hong, a professor at Korea University Anam Hospital’s Oncology and Hematology Department, will lead both the precision medicine project group and its subgroup K-Master. Leading the project for five years until 2021, Kim will manage clinical trials on drug candidates that are safe and effective on patients’ diseases after analyzing each patient’s genetic mutation. By receiving supports from drugmakers based on the examinations of genetic mutations, he will encourage patients at hospitals across the country to participate in clinical trials. Kim aims to analyze genetic mutations of 10,000

Korea Biomedical Review had an interview with Professor Kim to learn about the precision medicine project group, its purpose, and his plans. Kim also serves as chairman of the Korean Cancer Association’s board of directors.

Question: What does the precision medicine project group do?

Answer: It conducts genetic mutation tests for cancer patients. Depending on the results, it will find appropriate drug candidate and arrange a clinical trial. For this, the group will collect ideas earned from clinical tests by oncology specialists, analyze them and make use of them. The project group analyzes genomes of cancer patients, notify the results and match patients with pharmaceutical companies for necessary medication.

While the project group analyzes genetic mutations, the participating hospitals across the nation will hold clinical trials. The project group sends individual results of genetic analysis of issues or blood to corresponding hospitals and encourages them to participate in clinical trials. During the process, an international clinical trial, which aims to cure a particular genetic mutation, can be applied to Korea. Then, we will be able to improve local cancer patients’ access to clinical trials.

Q: Some say five years is not long enough to see a meaningful result in precision medicine. What do you think?

A: Precision medicine can apply to all kinds of diseases, but our project group focuses only on the diagnosis of cancer and cancer-related medical information. We are trying to make a joint platform where hospitals can share standardized medical information and make use of it.

K-Master aims to achieve a more precise diagnosis for cancer patients. By analyzing genomes and other data, the program will be able to develop a personalized diagnosis method and treatment. It will be hard to find all the individual diagnosis and treatment methods in just five years. At least on the level of patients groups, however, we would like to help shape up the right diagnosis and treatment strategies.

To do so, I’m trying to analyze all of the genomes of 10,000 patients for the next five years. After that, a local drugmaker or a multinational pharmaceutical company will find a candidate drug with confirmed safety and efficacy and open a chance to participate in a clinical study. Our goal is to have local patients participate in at least 20 clinical trials. Then, the number of patients getting treated through a clinical test will be about 1,000 to 2,000 at the minimum.

Q: Which patients, in particular, can participate in clinical trials under the precision medicine project?

A: Those who failed to get treated with standard therapies. Patients with no other treatment or with a specific genetic mutation which is being tackled in an overseas clinical trial can be part of the project. For patients to try an unapproved drug, participating in a clinical trial is the only way. They will have an opportunity to cure with a new medicine only when we open a chance to participate in a clinical test.

Q: What kind of drugs will be used in clinical trials?

A: We cannot consider all kinds of drugs. First, targeted therapies will be mainly used because they were made based on genetic information. We want to do a clinical test on a combination therapy, giving patients drugs that produced by different drug makers. However, there are many challenges as well. It is difficult to mobilize various medicines from different pharmaceutical firms and persuade them to participate, because of intricate webs of interests.

The reaction rate of targeted therapies is 75 percent, at best. Usually, it is 50 percent or lower. If we use an anti-cancer immunotherapy, the reaction rate can be as low as 15 percent. This makes a drugmaker with ownership of two candidate drugs tend to carry out a clinical trial on the combination of the two.

Q: How far has the project come?

A: The project group has established a business infrastructure and recruited several staff members, including experts. We have already designed four clinical trials – two for lung cancer, one for colon cancer and one for a rare cancer. Participating drugmakers are Chong Kun Dang, Yuhan Corp., Samyang Biopharmaceuticals, Merck and Novartis.

Q: What is the specific role of the project group in developing a new drug?

A: For a drug candidate to be developed as a new anti-cancer medicine, we need to find the right genetic mutation that the drug mainly targets. Then, we have to prove its efficacy in a clinical trial, after confirming it in theory or animal tests. The project group gets involved in the clinical trial stage. What’s important is that we need to give an opportunity to patients to try a new drug.

Before the use in a clinical trial, a drug candidate should pass at least toxicity and appropriate dose tests. If we proceed with a clinical trial and get the results of the drug candidate’s efficacy or side effects, we backtrack the cause of the efficacy and see whether it matches the genetic mutation we initially analyzed. We should also study any other factors caused the effectiveness. Genetic mutations vary, depending on types. One mutation can occur by a substitution of a base, while another can result from the omission of part of a gene. Some other mutation is from gene splicing. If we analyze which type matches better with the drug’s potency, our diagnosis and treatment will be more precise.

Q: Can we expect many biomarkers will be developed during the project?

A: I hope so. Biomarkers can be meaningful only when they are linked to the usefulness in clinical trials. It is essential to know if they can treat genetic mutation or not, or if they reduced the size of the tumor. Our project group will try to find the right genome information to fit such usefulness in a clinical trial. It means that our role is not only about analyzing genomes.

Q: Why did you make an online community called “Patient Care Me” for cancer patients?

A: The leading role of the precision medicine project group is to prevent cancer patients from choosing wrong anti-cancer therapies just because they didn’t know effective drugs were already available on the market. For example, although insurance covers next-generation sequencing (NGS), only less than 10 percent of patients who need it get its benefit, due to the cost and a limited number of hospitals available for the service.

Of course, the government also runs a website to provide cancer-related information, but the actual number of patients using it is quite low. The project group will make efforts to broaden access to the right drugs that can be effective in patients with genetic mutations. If patients fail to earn the necessary information and keep searching for information on various sites, those sites are not useful. It will not be very easy, but we want to operate a website that can offer the right information for cancer patients.

Q: What do we need to help the precision medicine project group achieve its goals?

A: We need to change our perception of the national project. Patients, as well as the government and some academic circles, do not like a massive national project. Researchers tend to think such project takes away their research money. But this project is in line with a global trend, and we’re going in the right direction. How fast Korea can set up a frame and push ahead with this project will decide whether we can survive the era of the Fourth Industrial Revolution.

For the precision medicine project to succeed, we need to ensure the security of personal information. We tend to fear against using our personal information because it is such a sensitive issue. What matters is that whether a credible institution can manage such information. We need to build a social consensus that establishing a secure information system will have a tremendous impact on the next generations.