[Music playing] [Text on screen: Ohio State Health & Discovery Health Talks] Gail Hogan: Thank you for joining us for Health Talks. I'm Gail Hogan. [Text on screen: The James The Ohio State University Wexner Medical Center] And Medical Oncology Expert, Dr. Richard Wu, is here to share some exciting news about an ongoing clinical trial at The James that is currently under FDA consideration for wider use. Dr. Wu, welcome. Richard Wu, MD, PhD: Yeah, thank you for inviting me here. [Text on screen: Gail Hogan Host Health Talks] Gail Hogan: Can you explain what TIL is, how this works? [Text on screen: Richard Wu, MD, PhD Medical Oncologist OSUCCC - James] Richard Wu, MD, PhD: Yeah. So, TIL stands for tumor-infiltrating lymphocytes. It's essentially a patient's own immune cells that have infiltrated into their own tumors. Gail Hogan: So is it a type of immunotherapy? Richard Wu, MD, PhD: Yes. It essentially harnesses patient's own immune cells to fight against their cancer. Gail Hogan: Can you explain a little more about how immunotherapy works for patients? Richard Wu, MD, PhD: So essentially with this approach, the surgeons will take, remove a piece of the patient's tumor and this will be sent to a laboratory where these immune cells are essentially growing out of the tumor and supercharged, meaning that their tumor killing functions are restored and then they're expanded to billions of them, which are then infused back into the patients to be able to help them fight against the cancer. Gail Hogan: So in this way, the patient's own body is helping them try to battle whatever cancer they have? Richard Wu, MD, PhD: Yes. Yeah, that's exactly the way it works. Yes. Gail Hogan: Is TIL used for any specific cancers? [Text on screen: Richard Wu, MD, PhD Medical Oncologist OSUCCC - James] Richard Wu, MD, PhD: So right now, the clinical trial is the furthest ahead for melanoma and I anticipate that will be the first indication for the TIL therapy. And there's also very ongoing exciting clinical trial going for other type of solid tumors such as lung cancer, cervical cancer, head and neck cancer. And I anticipate that in the future, in the next few years, we may see a wider use of TIL from different type of solid tumors. Gail Hogan: That is exciting. So this is considered a breakthrough? Richard Wu, MD, PhD: Yes, I think so. I think right now the issue is that with the existing immunotherapies we have, we still see roughly half of patients that don't benefit from the treatments. And so there's a huge amount of needs in that space. And I think with the TIL therapies, it does bring a new options to these patients that can potentially improve their outcomes. And in these clinical trials, I mean we see people getting TIL therapies having, roughly, there's about 20% of them that have complete response, meaning that their tumor disappeared completely sometimes for many years afterwards. So I think this is definitely a very exciting innovation in cancer therapy. Gail Hogan: You mentioned clinical trials, how many people were involved and how long did it take? Can you explain a bit about the clinical trial itself? [Text on screen: Richard Wu, MD, PhD Medical Oncologist OSUCCC - James] Richard Wu, MD, PhD: Yes. So this therapy was initially developed by very prominent physician-scientist Dr. Steve Rosenberg at the National Cancer Institute. And he has been working on this therapy since 1988. And so in 2005 he published a very important paper where he applied this approach to patients in a clinical trial in patients with a very, very advanced melanoma and was able to see a couple of patients that had a complete response of their tumor. And since then, his trainees and prodigies have taken this approach taken to various other medical centers here in the U.S. and throughout the world, which has led to development of this company called [inaudible], which is very involved in developing these therapies and potentially commercializing them once they're FDA approved. And the most recent clinical trial, so in the past, the clinical trial had been just looking at TIL therapy by itself so we know that the response rate is roughly around like 40 to 50% of patients. That's the number of patients that can benefit from the study. The most recent study that I think is the most exciting was actually came from Netherlands where they study about 168 patients and they randomize. So these patients, they have already failed treatments with the standard immunotherapies. And they randomized them to either getting the TIL therapy versus another type of immunotherapies that we have been using for the past decade or so. So it turns out that the proportion of patients that responded to the TIL therapy was much higher than the other immunotherapy. It was around 49% of patients that responded. And out of that 49% of the patients, around 20% of them were complete responders. Their tumors were completely disappeared. And we had never seen these kind of results with other type of therapies in the past or other type of immunotherapy in the past. So I think this is very exciting. Yeah. [Text on screen: Gail Hogan Host Health Talks] Gail Hogan: It is very exciting. Why was The James chosen as a site? Richard Wu, MD, PhD: Yes. So to carry out these therapies, I like to say it literally takes a village. I mean, we need to have multiple experts in different areas of medicines. We need to have experts that's very good experience in doing cellular therapies, bone marrow transplant. And then we need to have other experts like medical oncologists, hematologists that kind of work side by side with us because there's a potential risk of complications with these therapies, especially doing their part when patients are getting chemotherapy to clear out their immune system to make space for the TIL. And also for later part therapy where they're getting this IL-II, this is a growth factor to help expand these TILs inside the patient's body. And those two drugs are prone to cause some risks or side effects that require expert management. And I think at The James we have the necessary concentration of experts and also hospital facilities to be able to carry out this therapy safely. Gail Hogan: What did you find out at the end of all this research? [Text on screen: Richard Wu, MD, PhD Medical Oncologist OSUCCC - James] Richard Wu, MD, PhD: I would say that I think we're still at the beginning of the cellular therapy approach. There's ongoing very exciting research to try to make these therapies a bit more tolerable for more patients in the future. There's some approach that's trying to, there's some clinical trials that's trying to ask the question, can we replace the IL-II with different sort of a drug that can cause less side effects for patients and also can we give these therapies as outpatient rather than inpatient? I think those innovations on the TIL therapies, hopefully we'll be able to make it more available for a wider number of solid tumor patients. Gail Hogan: Well, did The James have anything to do with FDA consideration for this to be a wider use? Richard Wu, MD, PhD: Yes. We're actually one of the participating trial sites for the TIL therapies and we have accrued patients and we have contributed the data that's currently on the FDA review. Yeah. Gail Hogan: You said some patients are having a hard time to battle this type of cancer. So what does TIL mean for these patients? Richard Wu, MD, PhD: I think TIL is definitely a hope for these patients. Right. It's an important option for these patients that don't have any other treatment option that's available. And it's also an option that I think gives them a better chance of being able to keep the disease under control and potentially improve their long-term outcome. Gail Hogan: The James is one of the first in the country to offer this. Why The James? Richard Wu, MD, PhD: So I think most patients choose The James out of Ohio State because we're at the forefront of innovative cancer treatments. And then we have necessary concentration of experts and infrastructures to be able to handle these complex cancer treatments. And a lot of other places they may not have the necessary resource and manpower to be able to handle this. And I think at The James we are in a unique position to be able to do this successfully and safely. Gail Hogan: So what's the difference between TIL and CAR T-cell therapy? Richard Wu, MD, PhD: So CAR T therapy has been developed to treat blood cancers mainly, and these cells require genetic engineering to make them more potent. But the issue with the CAR T is that you're limited by being able to target only one target on the tumor cells and also it's not as easy to control their activity. So patients who are treated with CAR T-cell, they sometimes they can experience neurotoxicity where the immune system attack their nervous system or their immune system goes into very, very strong activation and such that can make them sick, can put them in ICU for example. With the TIL therapy there's no genetic engineering involved. And I mean these are essentially the patient's own cells, we just kind of multiply them to billions of cells. So I think there's much less risk of those kind of really toxicity happening. So I think it's a much safer form of cellular therapy. Gail Hogan: And moving forward, what other types of cancer do you think TIL could work for? [Music playing] Richard Wu, MD, PhD: I think the future is very exciting for TIL. There are already some promising clinical data for other solid tumors such as lung cancer and some of these cancers that's driven by the infection by the human papillomavirus or HPV such as cervical cancer, or head and neck cancers. And there's also ongoing study to look at the application of TIL to a very aggressive type of breast cancer called the triple negative breast cancer. So I think in the future, hopefully in the next few years, that we're going to see more robust clinical data to support the use of TIL in these other type of tumors. Gail Hogan: That is great news, Dr. Wu. Thank you. Richard Wu, MD, PhD: Yeah, no problem. Gail Hogan: And thank you for joining us for Health Talks. [Text on screen: Ohio State Health & Discovery Health Talks health.osu.edu] [Music ends]