Medical oncologist and researcher at OSU, Dr. Sameek Roychowdhury talks about controlling pancreatic cancer spread with a “basket trial.”
Interview conducted by Ivanhoe Broadcast News in 2023.
When our viewers hear the term precision medicine and many have probably heard of before, what are we talking about?
ROYCHOWDHURY: Precision medicine is just idea that we can classify someone’s illness better and therefore treat it the right way. We have had many instances where your doctor gives you a medicine and it doesn’t work. We try another medicine for blood pressure or a medicine for diabetes and it doesn’t work, we switch. We don’t really know what’s the best medicine for an individual patient. So around 2011, we started doing genetic sequencing of cancer at a larger scale and it has grown. Around that time, the idea of precision cancer medicine started. If we can sequence the genes of a patient’s tumor, all of them, 20,000, could we figure out what’s different for one patient versus another patient? They both may have lung cancer, but are their genetic features that are different, does that help us choose the best therapy for them, and it’s this idea of a precision taxonomy. How do we classify someone’s cancer better? Before 2011 where this started, we used to classify based on what it looks like under a microscope. Now you can use genetics to add to that classification and that’s our hope and dream. Can we classify your tumor and give you the right therapy, so we spend less time giving you the wrong therapy and hopefully have better outcomes?
Specifically talking about the FGFR mutation, can you tell me what it is, where it is, and how you find it and pin point it?
ROYCHOWDHURY: We’re still learning about the genetics of cancer. FGFR, or fibroblast growth factor receptor, is a family of four different genes. Since 2010 and 2005, we’ve learned that they occur in some cancers. With more genetics knowledge, we’ve learned that these mutations that can occur in the FGFR gene family, they can actually help cancer grow. In some instances, if you have an FGFR gene mutation in your cancer, it could be the culprit. It could be driving the cancer to grow, allowing it to invade organs where it doesn’t belong. If we know that’s the driver of your cancer, well, could we try to treat it? Thus far, there have been two different cancer types, liver cancer and bladder cancer in the past couple of years, where we’ve had a number of drugs approved. These drugs are smart drugs. They’re designed to go right after the FGFR gene and the protein that it makes. It’s been effective in those two cancer types, but we also know that these genes are being mutated in other cancer types, just not as commonly as we see in liver or bladder cancer so far.
With that knowledge and knowing that there are other types of cancer where that FGFR mutation exists, what does that allow you to do?
ROYCHOWDHURY: We’ve been running a number of so-called basket clinical trials. It’s a basket because we’re allowing patients with different cancer types to join the trial. Uterus cancer, cancer of the head and neck, cancer of the pancreas. The way we allow the patients to participate is if they have the FGFR gene mutation or one of them. Over the past 10 years since 2014, we’ve seen a number of patients who’ve had pancreas cancer with a rare FGFR gene. The first time I saw it, I swear I didn’t think it was that important. The patient benefited in what I thought was a good response. The tumors didn’t completely disappear, but I was impressed. Then it kept happening. What we’ve seen in this rare genetic subtype of pancreas cancer, we’ve seen them benefit really well. It doesn’t cure them of their disease yet, but they’ve responded really well compared to other patients with pancreas cancer where the only options are really chemotherapy and more chemotherapy. We’ve observed this in a couple of patients now and we hope to take this further and try to reach more patients who may have the same gene mutation.
Are the patients that you’ve seen in an advanced stage? Is it metastatic at this point?
ROYCHOWDHURY: The five patients we’ve seen have all had advanced and metastatic pancreas cancers that has spread beyond the pancreas here. It’s spread to organs like the lung, the liver, and lymph nodes. In that instance, if it’s already spread, patients do maybe 12 months or so, give or take, a few months with chemotherapy. In this instance with the FGFR, smart drugs or targeted therapies, we’ve seen them do as well as five years.
What about quality of life? Is it pretty well controlled during that cancer?
ROYCHOWDHURY: Yes. Chemotherapies IV and it’s every one to two weeks depending on the regimen, whereas these FGFR smart drugs or oral therapy is taken daily for a couple of weeks with a one-week break. These patients, again, if they’ve been able to do the therapy for three to five years, they’ve hung in there and it’s controlled their cancer, has given them good quality of life compared to chemotherapy, which I think tends to have a little more fatigue and some other complication sometimes.
Just clarification for me, the smart drugs, those are administered by IV?
ROYCHOWDHURY: Yes, the FGFR drugs are oral, they’re pills. You take them by mouth, you may take them for two to three weeks with a one week break. Sometimes we fiddle with that a little bit just to make the quality of life better for some side effects, but they’re pretty well-tolerated compared to chemotherapy.
What are the names of them? Is it more than one drug or is it a couple of them?
ROYCHOWDHURY: Yes. There are a number of drugs now available for liver cancer and for bladder cancer, and because they’ve had such success in those two cancer types, there are also many new drugs in development. So we have a dozen new drugs for FGFR. That’s really good for both patients and doctors because we have a chance now to optimize the best therapies, the best regimens, and the best outcomes. When the first drugs came out, they weren’t necessarily the best yet, they were first in class. Now we’re hoping to see better outcomes and hopefully better side effect profiles as well.
Now this isn’t a cure, but this buys patients and for some patients significant time. What does that mean to both the patient and the families?
ROYCHOWDHURY: Our hope in the long term is to find ways to make this a curative strategy and to think about how we can improve what we’re doing, but to me, giving patients more time with their loved ones, their family, their friends, that’s what it’s all about. That’s the why of cancer research. We want to help people live longer with better lives and beat the cancer if we can.
When I ask you a little bit about Bob, can you tell me about him?
ROYCHOWDHURY: Yes. He’s a brilliant man. I’ve known him for many years and he’s one of those patients who’s taught us about what we’re talking about today. Patients like Bob are the heroes of cancer research. They participate in clinical trials and clinical research. He’s been supplying us blood for years, as part of his studies that has allowed us to make some advances in blood diagnostics to monitor his disease, but he’s really the hero of this research. Based on what we’ve learned from him, we’ve written a new clinical trial to reach more patients. I know he’s excited about that. If you ask him, if he wants to be a part of research, his answer is yes to help others. That’s been his attitude the entire time that I’ve known him now years.
Can you tell me a little bit about the new clinical trial. Again, you’re not recruiting just yet, but you’re in the process of getting this up and running?
ROYCHOWDHURY: Yes, we have an approval from a drug company that we’re working with. We’ll hope to write, develop, get it through the regulatory steps by summer of 2023. It will be a telemedicine-enabled clinical trial. It’s really innovative because that’s not the way clinical trials are typically done. We’ve learned this from COVID. We’ve had our own experiences treating patients in an emergency basis during COVID. Even right now we’ve got a patient with pancreas cancer in FGFR in Florida who we’re able to support with treatment. He hasn’t traveled to see us since his first visit with us in August of 2022 and so we continue to follow him remotely. We collaborate with his local doctor and we’ll be able to reach patients all over the U.S. This is not a common genetic finding in pancreas cancer, it’s probably around one percent of pancreas cancer, but these patients can do so well if they can access this drug or a drug like that after your first mark drug therapy.
And again, the new clinical trials focus just on pancreas?
ROYCHOWDHURY: Pancreas cancer patients who have an FGFR gene. We know there are certain FGFR gene mutations that we know we can treat. Part of our work now is also to study novel or new FGFR mutations and take them into the laboratory and prove that they can be sensitive to these FGFR drugs as well. We think there’s going to be more mutations that we can use to classify and go back to that precision cancer medicine, identifying which patients can benefit from which drugs.
The FGFR pancreatic cancer trial that you hope to have approval and have it set by 2023 summer, OSU will be one site. Is it a national trial? Will it be a multi-center trial?
ROYCHOWDHURY: This is going to be a unique trial. First, we can reach patients anywhere in the country via telemedicine. Second, we will be the only clinical trial site. What we will do is we will do our telemedicine visits, we’ll have them get their blood work and scans back at home, we will partner with their local oncologist for all of their treatments. They will have additional visits that they do locally and they will be our boots on the ground to help us if there are any problems locally. Fortunately, we have 10 years of experience with FGFR drugs, so we know by the day what potential side effects someone could have. We know what to anticipate, but we sometimes may need a local oncologist to help us. I think this will be a new model for how we do clinical trials. In the old model, if you didn’t have a trial within a drive distance, you couldn’t probably do it. Most people can’t afford to fly for weekly or every two-week visits for a clinical trial. It’s also very hard on a patient’s body and life to have to do that. This will hopefully set a new path forward for clinical research.
END OF INTERVIEW
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