Robert Fenstermaker, M.D., Professor and chairman of the department of neurosurgery at Roswell Park Cancer Institute in Buffalo, New York, talks about a vaccine that may make a huge difference for patients fighting glioblastoma.
Interview conducted by Ivanhoe Broadcast News in September 2016.
We’re here to talk about the brain cancer vaccine that you have developed with Mike, In your words tell me a little bit about the vaccine and how it’s different than the therapies that we currently have on the market like chemotherapy and things like that.
Dr. Fenstermaker: The vaccine that we’ve developed is a form of immunotherapy that stimulates the patient’s immune system to attack their tumor. This is different from lots of therapies that have been used in the past, which are drugs to combat the tumor and attack it directly.
The Survivin is the targeted protein, Why that particular protein? It’s common to all cancers from what I understand, but why that?
Dr. Fenstermaker: Survivin turns out to be one of the most specific cancer proteins that distinguish the tumor from normal tissue. If you develop an immune response that attacks Survivin you can treat the tumor without affecting normal tissues to a large extent. It should be relatively nontoxic.
The Phase I trials concluded into Phase II trials and the outcomes are promising, right?What are your thoughts on that?
Dr. Fenstermaker: Well, in the Phase I trial that we conducted, we were able to show that the vaccine is safe and produces little toxicity in patients. Of course that needs to be studied further in a greater number of patients. The Phase II study which we’re conducting right now, we’re looking to see what the effects are on tumors in patients and does it prolong survival. So far the results are encouraging.
For the patients who were in the Phase I trial not only was life extended but there wasn’t a severe detriment to the quality of life because it wasn’t one of these harsh therapies, correct?
Dr. Fenstermaker: Right. Patients experienced very little side effects in contrast to some forms of therapy. Some forms of chemotherapy in particular, but again that needs to be studied in a much larger number of patients.
How do you feel as a physician? I mean, you’re on the front lines treating patients with brain cancer. These are very aggressive forms of cancer and this is very revolutionary in a lot of ways because mainly there’s the lack of toxicity. How does it feel for you as a physician after all these years having a certain protocol and now there’s something that really could radically affect not only their outcomes but their quality of life?
Dr. Fenstermaker: It’s a great feeling to be involved in this. I started in this knowing that surgery by itself was probably not going to cure for a large number of patients with this particular disease. To be involved in something that has a chance to extend people’s survival in a way that’s noninvasive and has low toxicity is really tremendously rewarding.
Could you remember when you were doing the trials, do you remember how you felt the very first time that the results starting coming back in and they were positive, do you remember what that felt like?
Dr. Fenstermaker: You never know what to expect, but as the trial goes along and you see that a number of patients are doing better than you would have expected with conventional therapy it really is a boost and it spurs you to go on and to really focus your effort on this study and the patients.
Has it changed your approach at all as a physician, knowing you now have another weapon in your arsenal, something that you can give patients? Does it change your approach in the way you approach patients now?
Dr. Fenstermaker: Well, I think this treatment is still not approved by the FDA so it’s not available. It remains to be seen whether it will become available to patients if it helps them enough. Knowing that immunotherapy offers such great potential is really very encouraging. It tells us that there’s a whole new realm of therapies out there that are barely investigated and it’s just very promising.
This trial is being conducted; chemotherapy is administered. So it is still a part of the whole protocol for the trial. Does that muddy the results at all because it’s not done in the absence of chemo?
Dr. Fenstermaker: Not really. The patients in this trial are receiving standard therapy which they would have received otherwise, plus the vaccine. We have a very good information base or database on how patients respond to standard therapy. It is relatively easy to compare our results to those of patients who have been treated otherwise. Nevertheless it will be important to do a Phase III study randomized at some point that compares the new treatment to standard therapy in two groups of patients.
Do you see in your case the majority of the patients you see if this continues along as you hope when it does become approved? Do you see it helping a majority of your patients? Can you quantify that right now, or the types of patients that you see currently that would be eligible?
Dr. Fenstermaker: I think it’s really hard to put numbers on things at this point. I think no cancer therapy is universally applicable to patients. It might prove to be effective in other forms of cancer in a certain segment of patients but perhaps not all. The jury is really out on that still.
This is something that could not only be effective for brain cancer patients but for other types of cancer because this is a protein that is found in all types. I think logically you would include them right?
Dr. Fenstermaker: Right. One of the reasons we focused on Survivin in the beginning was that it is a relatively universal cancer antigen. It is present in many different types of cancer. While we’re focused on brain tumors we’re also interested in investigating other types of cancers. In fact there is currently an ongoing trial for patients with a cancer of the bone marrow called multiple myeloma. We are very interested to see the results of that study as well.
You wouldn’t really have to tweak the vaccine very much because it’s targeting a common protein. So the type of cancer doesn’t really matter, just as long as it contains that protein, right?
Dr. Fenstermaker: The type of cancer may not matter. That remains to be determined, but definitely the target is present in many types of cancers and in theory should be able to be targeted for them as well as brain tumors.
The next step, I understand, is getting more patients enrolled in Phase II, getting the Phase II completed, and then maybe another year out getting maybe to that Phase III which is the last step.
Dr. Fenstermaker: That’s right.
Then at that point then it would be available widely on the market, do you have to go through FDA approval?
Dr. Fenstermaker: Well, if the Phase III study is positive then we would hope that the FDA would approve it for general use. That result is a few years off yet though.
Would you sort of describe this particular type of brain tumor, what the prognosis is and why new therapies, new treatments are so important.
Dr. Fenstermaker: This trial is focused on a tumor called glioblastoma which is the most common malignant brain tumor and it remains a devastating cancer. The average survival is a little over fourteen months for patients with this disease. It’s imperative that we find better treatments to extend survival and preserve a patient’s quality of life.
These types of tumors, do they cross all ages, genders? Is there any particular group?
Dr. Fenstermaker: This cancer can strike at any age although it tends to be adults more so than children. It is a cancer that is devastating beyond the numbers of patients that it affects; affecting the family and a person’s function.
It appears it’s very, very aggressive. It’s not something that’s kind of chronic.
Dr. Fenstermaker: Usually it appears rapidly and if some intervention isn’t done it can lead to death very quickly.
Have there been any new treatments for glioblastoma in the past number of years? Is this the first new treatment?
Dr. Fenstermaker: It’s not the first, but it gets pretty complicated at that point. The treatment for glioblastoma has not changed radically in the last thirty years or so. It’s still the mainstay of surgery, radiation therapy and chemotherapy; although there is one form of treatment that uses radio frequency energy to slow the tumor down. That’s fairly new.
This particular cancer, it is aggressive and the outcomes are not good. Is that the reason you targeted this particular form of brain cancer for these tests? Or is it that the Survivin protein expresses itself so clearly in that type?
Dr. Fenstermaker: It’s a combination of things. For one thing, we deal with a class of tumors called glioma. Glioblastoma is by far the most common glioma in that group. It’s also the one that expresses the target protein at the highest levels.
Tell us what you’re doing here, What are you investigating?
Dr. Fenstermaker: We’re studying a tumor called glioblastoma and the effect of immunotherapy in the form of vaccines to stimulate the immune system to kill glioblastoma cells in patients.
END OF INTERVIEW
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