Kelvin Lee, M.D, Chair of Immunology at the Roswell Park Cancer Institute, talks about a lung cancer vaccine developed in Cuba that may save the lives of many suffering with lung cancer.
Interview conducted by Ivanhoe Broadcast News in June 2016.
Let’s talk a little about the lung cancer vaccine. First tell us what that means people here that were vaccine and it means a lot of different things and what are we actually doing here?
Dr. Lee: Most cancer vaccines that we’ve developed over the last few years really have been designed to target the cancer cell itself. The idea is to activate the immune system; the immune system goes after the cancer and tries to kill the cancer cells directly. What the center for molecular immunology in Havana have done is developed a novel vaccine that has taken a different approach and that vaccine is designed to elicit an immune response not against the cancer directly but against a circulating growth factor, called Epidermal growth factor (EGF); that the cancer cells really need to grow and survive. By targeting this growth factor and neutralizing it, essentially it depletes the EGF out of the system and the cancers starve or they stop growing. The idea there is instead of going after the cancer directly it goes after the growth factor and prevents the cancer from growing, with the idea of turning the cancer really into a chronic disease. Many chronic diseases like high blood pressure or diabetes we don’t really cure but we can manage them, patients can have a perfectly normal life and that’s the idea of this vaccine, it’s really designed actually to stop the cancer from growing and the consequences to that approach are the vaccine itself is inexpensive, it’s easy to give, it’s given as a shot once a month, it has very little toxicity so patients really do very well with it and a number of clinical trials that have been done by the Center for Molecular Immunology or the (CIM) have in fact shown significant increase in overall survival for the patients who were vaccinated. Such that the most recent trial they did was a very large Phase III trial about seventeen percent of the lung cancer patients, with advance lung cancer, were alive at eight years showing that really you can go a very long time with a very high quality of life with this vaccine approach.
The people who were given the lung cancer vaccine eight years later they were still here.
Dr. Lee: Seventeen percent of them, and these were people with very advanced lung cancer, again Stage IIIB, Stage IV lung cancer. Metastatic lung cancer is a very advanced lung cancer, and seventeen percent of them are alive in eight years. Their cancer didn’t disappear but it stopped growing, they had an excellent quality of life, they can get their vaccine by their primary care physicians in their local community; they don’t have to go to a big hospital or a cancer center anywhere, their primary care doctors actually deliver, in Cuba the primary care doctors delivers it to the patients in their homes.
In that, statically we hear seventeen percent and while that doesn’t sound like a high number that is statically significant when you’re dealing with lung cancer?
Dr. Lee: Definitely, in that trial the control group got best supportive care available in Cuba and all their patients I think in that control group had passed within four years. You had a significant population of patients that really did pretty well with the vaccination.
The other percentage of patients not in the seventeen percent, what happened with them, do you know?
Dr. Lee: If you looked at the entire vaccinated group compared to the control group, if you looked at the entire group there was a significant increase in overall survival for about three months in the vaccinated group compared to the controlled group. However, if you looked at the patients that had the higher levels of EGF and before they were vaccinated, those patients did much better their average of overall survival increase, but I think six to nine months as an average compared to the control group if they got vaccinated and then again there was a significant proportion of patients that got vaccinated that really lived much longer than what we really expected.
In that alone gives you hope for this treatment and this therapy that down the road as you continue to develop it and to work on it that you can extended those months to years of life?
Dr. Lee: The idea there is two that there are two approaches, there are two potential real areas to benefit. One is in the treatment of people with lung cancer and patients with advanced lung cancer, combining it with other immunotherapies so that it might enhance immune response which is the trial we are planning to do; the question is can we even get a better immune response and better outcome for patients with lung cancer. The other arena that is very exciting is whether or not if we can use this vaccine to prevent lung cancer. The idea there is not to vaccinate kids in elementary school or anything, but we know that especially in the United States with lung cancer screening we’re going to catch a lot of patients. Now with Stage I, Stage II lung cancer they’re going to go to their thoracic surgeon, they’ll have the tumors removed and technically they’re cured. However, we also know that many of them have smoked most of their lives, have multiple areas that could potentially, could develop into lung cancer, such that about fifty percent of them will develop a second lung cancer within five years. Right now we don’t do anything for those patients, we simply watch them; and if we had a vaccine that was inexpensive, that was easy to give, that had no side effects and was effective on lung cancer we could vaccinate that population, reduce their risk of lung cancer; that would be a major step forward for tens or hundreds of thousands of people in the United States. But even further than that, our lung cancer prevention group tells us there are pretty good algorithms right now to calculate your risk of getting lung cancer based on your smoking history, family history, etc. It’s very similar to when I went to the doctor recently, which was quite a shock, I got my cholesterol my triglycerides checked they said, Oh they’re both high and that was great and then they calculated my risk of having a heart attack in the next eight years or five years was at eight percent. They said starch on a statin. We are developing similar algroloms to determine how, what the risk of somebody based on their smoking history for example, what the risk of getting lung cancer is. If we could calculate that and you go to your doctor and your doctor comes back and says, you got a probably ten percent chance of getting lung cancer and the next 15 years, one option will be to vaccinate those patients also. They’re not really patients, they haven’t got lung cancer yet but they are at higher risk. Those populations of people, higher risk smokers; again there are probably millions of people in the United States, tens to hundreds of millions of people globally. The great thing about this is, this, the IM vaccine is that it was developed so it can be delivered in the primary care setting by primary care doctors, nurse practitioners and pharmacists. You can deploy this vaccine worldwide, which is what we think the biggest potential public health benefit vaccine will be.
Does Cuba hold a patent on that?
Dr. Lee: Yes, they do.
They hold a patent so Roswell is involved in bringing it to this country and getting it to sanction for a better term.
Dr. Lee: Right
In this country?
Dr. Lee: Right.
They have obviously shown that they’ve been using it for years.
Dr. Lee: Right, exactly, which is why we are so upbeat about this vaccine, and you already know it has a great track record. It is actually approved for a standard clinical use in Cuba, also Paraguay, Peru and I think it’s going to be soon approved by the Colombian version of the FDA. I think that there is a very good track record of safety, the effectiveness and now the question is what else you can use it for. I mean Cuba really; they’ve got great health care. I mean they have health care metrics that’s as good as the United States, as they spend one fifth of what we spend here in the United States. They can only do certain things; they really focus on their number one killer of the Cuban people in the cancer realm, which is lung cancer. They would love to know if this vaccine works in colon cancer, in head and neck cancer, in breast cancer, prostate cancer, all other cancers that potentially might respond to this kind of therapy, they would love to know if it worked in that area, they love to know if you could combine it with other Immunotherapy’s to get a better immune response, they would love to know it in prevention settings. All those things Roswell Park can do and is looking to do. It’s a great collaboration, they have a great innovative vaccine; they’ve done a tremendous amount of work demonstrating its safety and its effectiveness. We have the ability to test this vaccine in multiple different settings, both prevention and other cancers, and so we see this as a great partnership going forth.
It’s a gateway to these other cancers which (interrupted by doctor)
Dr. Lee: Yes.
The head and neck, those are very difficult.
Dr. Lee: Yes, exactly.
Let me make sure, I just want to circle back and make sure so that I understand this so I can put it in layman’s terms. So, the growth factor is a protein right? So this basically doesn’t attack the cancer cells it attacks the proteins that forces them to grow?
Dr. Lee: Right.
With this vaccine it doesn’t eliminate the cancer it halts it?
Dr. Lee: Right.
As you said, you treated just chronic disease I could be walking around with chronic colon cancer, but if it isn’t growing?
Dr. Lee: That’s exactly right.
This becomes like a benign tumor?
Dr. Lee: Exactly, the only thing that really endangers or the major thing that endangers cancer patients is the cancer gets bigger. If their cancers don’t get bigger then you’re exactly right, it’s like a benign tumor and people can live with that for a very long period of time, especially, if the therapy itself is well tolerated and has very few side effects.
Three groups I want to address, if you could address these for me. The average person watching this and they don’t have lung cancer and they don’t think they have a history; they know people who have cancer, what does this mean for the average person, in cancer? Getting cancer, my family has it will this impact them. What does this means down the road?
Dr. Lee: Right now you know we are talking about lung cancer, but if it turns out that this vaccine is effective and say breast cancer and you have women that will have breast cancer but are high risk, can you immunize in that setting to reduce the risk? Or, if somebody has a risk of getting head and neck cancer or colon cancer we know that targeting this access does work in colon cancer. The question is if somebody has a higher risk because they got more polyps, or they got a genetic background of or a family background and they can potentially get colon cancer would this reduce their risk. As we determine if this vaccine is going to be effective in a wider range of cancers certainly that would impact a larger number of people that may get cancer but don’t have cancer; but have risk factors that may predispose them to get it.
The most immediate group is really going to be those who are at high risk for lung cancer and those that already have it.
Dr. Lee: Right.
This can affect them very quickly.
Dr. Lee: Right.
This can have a direct impact on them and may not (interrupted by doctor)
Dr. Lee: Right.
Like ten years from now.
Dr. Lee: Right, exactly, today. The other group we haven’t really explored really is that because this vaccine is designed to be deployed in the primary care setting, medically underserved areas in the United States and globally, many people can’t afford to drive three hundred miles to go to their local oncologist to get chemotherapy or even if they went you can’t really, they don’t really want or can’t really afford to have really toxic therapy given to them because they are going back to their homes two hundred miles away. The idea of being able to employ pretty sophisticated cancer immunotherapy but deployed out in the middle of primary care setting, rural areas, and medically underserved areas in the United States. Certainly globally, I think this is a very important characteristic of this vaccine that perhaps is under appreciated in sort of the era of high expensive, high tech therapy. More people might really benefit from something they can get, again by their nurse practitioner or their pharmacist, immediately as opposed to driving, four hundred or five hundred miles to a cancer center to get their therapy.
But that’s cost effective.
Dr. Lee: That’s another aspect that haven’t really explored, but if you have a vaccine that cost a $100 dollars, $10 dollars, a $100 dollars a month and it works just as well as a drug that costs $10,000 dollars a month, from a health economics standpoint even if they worked exactly the same one is much more economically efficient than the other especially if it could be again, delivered at the primary care level. We think that those are other perhaps more subtle aspects of this vaccine. Certainly, that was the way that our Cuban colleagues designed the vaccine, specifically with those characteristics and we can see how that might, we can envision how that might impact those aspects in the United States and elsewhere.
If you can just update where we stand today with this how close is it going trial and how close it is coming to market.
Dr. Lee: The first part actually is the easiest. Two components to getting it in the clinical trials, it is part of this is in the United States I think we are sailing in uncharted waters. We always like to say we’re a very small boat in unknown seas. The whole process of getting this approved is not because of the embargo, and Cuba’s relationship with the United States is a lot more complicated than sort of if the drug had come out of Germany, for example. The two components, the two medical components are that the approval of the clinical trial itself, the very first clinical trial will be a Phase I/Phase II clinical study in advanced lung cancer at Roswell Park. That trial has been approved by the institutional review boards and all the regulatory components that have to say if the safe trial is well designed: that’s one component. The second component is an investigational new drug application to the FDA. The Food and Drug Administration really wants to know is the drug that you are going to give in your clinical trial has it been manufactured in a good way, a reproducible way, are the standard operating procedures all in place so the quality and controlled measures are all there. We are probably only a few weeks away, probably less, of getting that application to the food and drug administration for them to review, so that’s the larger component. The Food and Drug Administration then has 60 days to review it and if they don’t have any issues with it the trial can open; so what I really think is that we are really looking at something that will be the clinical trials really within this, the third or fourth quarter of this year.
This year and how soon and how quickly could they get them to the patients in general?
Dr. Lee: How quickly could they, I think they could be very quick. I think there are large numbers of patients that are that are available for the clinical trials. There’s a lot of interest in the clinical trials.
How quickly are they going to market (interrupted by doctor)?
Dr. Lee: That’s a different question, I mean their real issue is going to be do we see efficacy in the trials or we efficacy in safety in the trials that we see and then and the presumption would be that we would see the same thing that our Cuban colleagues saw.
It’s basically proven what Cuba has already found?
Dr. Lee: Right. In the U.S. population and then the next question is the development process, the commercialization process of CimaVax is a little bit different than you would expect from a traditional old Phase I kind of drug. Because they already have Phase III data and safety data and efficacy data; it’s already on the market in other countries. The question is how would the FDA, if we get through this very first hurdle, getting it showing that the safety component is the same, how would the FDA then deal with the large body of data that is already there and this doesn’t even address how do you get it into the United States if the embargo is still in place. How does the FDA go down to a plant in Cuba and inspect it. There are a large number of other political and diplomatic issues that need to be resolved before anything could go forward with the commercialization. No really we are keeping our head down and we are keeping ourselves focused on the clinical trial and we figured that commercialization stuff and getting it to people on a regular basis will figure itself out over time.
OK, if you had, for the average person who’s watching this, if you had one thing to tell them what you want them to come away with after seeing this piece regarding this and what would you tell them from your perspective, what would you want people to know about this?
Dr. Lee: We would want them to know, I mean that there is really a great innovative immunotherapy progress in cancer that is really coming from a variety of different places. I would have never guessed that Cuba would have really cutting edge immunology immunotherapy down there; yet they do. It’s a very rich environment and a rich time right now with great ideas coming from all sorts of places that you would have never expected. So, this is a very promising time for cancer therapy in general. It is really a very promising time for cancer immunotherapy.
Dr. Lee: Oh, this is just fantastic and I treat patients with cancer and the excitement is that when you can see something that can potentially impact, again hundreds of thousands to millions of people worldwide, you can actually help those people. I think that’s amazing, I think that’s really cool. One thing that I really didn’t talk about is that this is one vaccine of probably seven or eight that the CIM have in their portfolio that they’ve done clinical trials in so there’re other vaccines that are there in there pipeline that treat blood cancers. For example other cancers; so it’s really exciting. This is not a one off; we are developing this one and there are other things in their pipeline that are equally exciting and they’re moving forward also.
But as a physician this is why you got into it?
Dr. Lee: Yeah.
To be able to would you are able to imagine a career to be able to say this somebody why we have this ground breaking thing that could alter the course of the day?
Dr. Lee: Yeah.
What is that like?
Dr. Lee: That’s incredible. Some of my favorite medical professionals are the people that go out into the rest of the world and they’re vaccinating against polo. They’re going from village to village, vaccinating in the poorest countries. They’re vaccinating against polio there, they’re trying to stem this incredibly deadly disease with this incredibly effective treatment. I keep telling our friends here, our colleagues here, wouldn’t it be great if we were just driving across some poor country going from village to village saying, what’s your cancer risk? Vaccinate you against lung cancer? That would be phenomenal. I think that will be really exciting.
Will Roswell Park benefit financially from this or is that undetermined at this point?
Dr. Lee: It’s not determined at this point. The whole commercialization piece really is still up in the air.
In the interest of full disclosure, anything else I would need to know about Roswell involvement?
Dr. Lee: No.
Anything else?
Dr. Lee: No.
Third party: I have a couple of questions but off camera.
Ok, we are good.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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