Nationwide Melanoma Clinical Trials

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A Stand Up to Cancer (SU2C) Melanoma Dream Team, led by TGen President Dr. Jeffrey Trent of Phoenix, is launching a set of nationwide clinical trials on a form of melanoma skin cancer that affects about half of all people who get the disease. Mayo Clinic in Arizona is the only clinical trial location in our state. Dr. Trent and Dr. Alex Sekulic of Mayo Clinic will discuss the melanoma clinical trials.

TED SIMONS: T-Gen and Mayo Clinic Arizona are launching a set of nationwide clinical trials focused on a particular and common form of melanoma. For more on the trials we welcome T-Gen President Jeffrey Trent and Dr. Alex Sekulic of mayo clinic, good to have you both here. Thanks so much for joining us. Clinical trials on melanoma, and a specific kind, talk to us about this.

JEFFREY TRENT: Well there's no question melanoma is one of the most difficult cancers in part because of its incidents in a state like Arizona. But also when it spreads across the body it's been very difficult for us to deal with. Dr. Sekulic can mention there's been remarkable progress in the last four or five years but unfortunately it's still a really stubborn enemy, no question.

TED SIMONS: What makes it so difficult? Is it the way it spreads? Is it the speed at which it spreads? What's going on here?

ALEX SEKULIC: I would say both. It is one of the cancers that has been synonymous with really aggressive clinical course, really poor outcomes for many, many, many decades. As Dr. Trent mentioned, advances that were made over the last five or ten years that are based primarily in the understanding of how the human genome is structured and how the cancer misuses that information to its own advantage against the host has fueled development of new therapies.

TED SIMONS: Indeed. Now, these clinical trials, is this immunotherapy we're talking about that we've focused on or other aspects?

JEFFREY TRENT: That's a great question. This is really one of those genomic enabled trials like the President's precision medicine trial in which the patients entering on this have all received an immune therapy or can't receive one for some reason and unfortunately that subset of those patients have failed. This is a way to target the patient's genome, align it with a specific drug, and again, as you said a multisite study across the nation.

TED SIMONS: Tell us the difference between immunotherapy and targeting a specific gene or genome.

JEFFREY TRENT: Well, Dr. Sekulic is really one of the experts in regards to this, that combines studies on both, but our own immune system really can broadly affect in a very significant way cancer cells. The genetic information sort of pinpoints key Achilles heels that we can really take advantage of.

TED SIMONS: And please, add to that. People understand the genome and they know there are certain markers out there that suggest maybe a predilection towards certain cancers and all sorts of things. These folks have already tried immunotherapy and it doesn't work or it doesn't work as well as it should?

ALEX SEKULIC: So there are two concepts here. One is development of therapies to things that are commonly seen in a cancer, so you can think of a cancer as a cell that goes rogue. It uses the information in the genome which every cell of our body has. It abuses that information to its own advantage. It starts to grow when it shouldn't grow, starts spreading when it shouldn't spread. Understanding what genes are misused and targeting those genes, turning them off, is what we call targeted therapy. That's one approach. The other approach is to say, can we enable our own immune system to recognize better and eradicate the cancer. That would be immunotherapy. Advances in both areas have been dramatic, but not every patient benefits from those, either because they cannot receive those therapies, they don't apply to them or their cancer has not responded to those therapies. That's a significant proportion of patients.

TED SIMONS: For a cancer that doesn't respond to those therapies, what does that mean about the cancer?

ALEX SEKULIC: Well, it means that in that particular patient it may not be just the cancer. It may be also the immune system that may now be responding equally to these immune-stimulatory drugs that we are recently starting to use, but in this particular population of patients, this is a population where there's no homogeneous one, what we call molecular driver. So the idea is that if you can look into the genome of the cancer in a given patient, you may identify what drives the cancer in their particular case and match a drug that may work in that case but maybe not be relevant to the next patient in the trial. It's basically personalizing that selection.

TED SIMONS: Very focused. These clinical trials, how will they be conducted?

JEFFREY TRENT: So picture the FDA has approved this. We have a set of drugs that are sitting on the sidelines ready to use for these patients. We're capturing the most significant amount of genetic information that has ever been undertaken for this. And we're going to match those up to be able to give an individual patient a single drug that's pulled out of that, that's tailored to their own genetic information. Then we generate that information here at T-Gen, samples from Yale, samples from all three Mayo Clinics across the country, the samples come in. And then physicians like Dr. Sekulic sit on a board and review the information and finalize that decision. That's really how this process of this trial works.

TED SIMONS: Now are there are some folks who will have this process and some sort of other, you know, some guideline folks who don't have the process? Obviously is it blind? Is it double blind? How does it work?

JEFFREY TRENT: That's a great question. This is a randomized trial from the FDA, part of it would go on to the standard of care arm and part gets this investigational information. We are able to combine the two and that's really a unique part of this trial.

TED SIMONS: And I would imagine those who maybe don't have the particular targeted therapy in the first go-round, if something is found they're still eligible, aren't they?

ALEX SEKULIC: Absolutely so. The patients can cross over, so to speak. If a patient is randomized into a standard of care arm and they are not responding in the first period of evaluation, they are then crossed into their own molecularly informed therapy choice.

TED SIMONS: When it comes to what we recognize as standard case chemotherapy, radiation, these sorts of things, there are still melanomas that respond better to those treatments than immunotherapy and genomic targeted therapy?

ALEX SEKULIC: It is possible. But the reason why we are all excited in melanoma, which is a poster child for other malignances at this stage and other cancers, we're excited about these new treatments is because the old treatments did not work. We would typically say in old treatments we had to rely on statistics to tell us if something is working. And that's because the benefits were marginal, small. We needed to look at large numbers of patients to see a tiny, tiny little benefit. These new therapies are really changing that, much more dramatic, much faster response.

TED SIMONS: We had the PBS series on cancer not too long ago and this -- everything that was shown of this immunotherapy, we've actually interviewed people who are just amazing stories where they were just being -- just crushed by chemo, they tried immunotherapy and A, they are not crushed, and B, they get better. It has to be optimistic out there.

JEFFREY TRENT: Tremendously. It's probably the most exciting time and the combination of these two are really what we believe are going to bring to bear hopefully curative intent for some of these trials so combining the immunotherapy, the very selected targeted therapy which have less side effects than standard chemo, put that together in a framework that's tailored to an individual, and that's the great hope.

TED SIMONS: You've mentioned curative. Are we talking about cures here or are we talking about just being able to manage and treat the cancer?

JEFFREY TRENT: In this trial we're really looking for hopefully progression free, survival is one of the key things we're looking. How long can we keep the patient doing well. Cure is the long term hope we all have.

TED SIMONS: Side effects, immunotherapy, targeted gene genetic therapy? Do we see many side effects here?

ALEX SEKULIC: Depending on the drug and depending on the situation. Most of the immune targeted approaches will have some side effects in terms of autoimmune type of profiles, but it is impressive to see that the newest ones are actually very benign in terms of side effects when you compare it to the benefit given -- received. When we look at targeted therapies they also have side effects. They are not without side effects but we don't see those broad toxicities that are associated with chemotherapy.

TED SIMONS: And Doctor, I think it was mentioned earlier, the advances in treating melanoma are impressive and moving very fast. Why there, but we're not seeing the same things with pancreatic cancer?

JEFFREY TRENT: Well it's a great question. One is the number of mutations in melanoma is the highest among almost any cancer we have of the 200 different types. Part of that is the sun beating down on us and the immune system has many different handles to latch onto. That's one of the many reasons we think this is the case.

TED SIMONS: Alright, well it's good to have you here. Congratulations on the trials, good luck with the trials, and thank you both for being here, we appreciate it.

ALEX SEKULIC: Thank you.

TED SIMONS: Wednesday on "Arizona Horizon" we will talk about what it takes to be a foster parent. And we'll hear about an effort to help those with developmental disabilities, it's at 5:30 and 10:00 on the next "Arizona Horizon." That is it for now, I'm Ted Simons. Thank you so much for joining us. You have a great evening.

Dr. Jeffrey Trent : TGen President, Dr. Alex Sekulic : Mayo Clinic

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