How Can Lung Cancer Patients Stay Involved in Research to Innovate New Treatments?

Living Well With Lung Cancer

Downloadable Program Guide

Noted lung cancer experts, Dr. Lecia Sequist, Marisa Wittebort, a lung cancer advocate with a very rare mutation, ROS1, and lung cancer advocate, Janet Freeman Daily joined this program to provide an expert perspective on the impact of patient involvement in research and how both lung cancer patients and care partners can contribute to bringing new medicines to the market.


Transcript:

Andrew Schorr:
And greetings from Carlsbad, California, near San Diego. I’m Andrew Schorr from Patient Power. Welcome to this Patient Empowerment Network program. I’m so excited. It’s where we can learn how can lung cancer patients stay involved in research and innovate new treatments to benefit the lung cancer community.
Let’s meet our guests. First of all, we wanted to have Marisa Wittebort, who is a ROS1 lung cancer patient, but unfortunately Marisa is having a medical procedure and so she couldn’t be with us. But joining us from New York City is her sister, Jess, who’s been with her every step of the way. Jess, thank you so much for joining us. And, first of all, how is your sister doing?

Jessica Wittebort:
Yes, she’s doing good. Thanks so much, Andrew for having me join today. Marisa’s good. She has another pesky effusion that needs more attention today, so I’m joining you, but thank you very much.

Andrew Schorr:
Okay. Well, all our best to Marisa.

Jessica Wittebort:
Yeah, I appreciate that.

Andrew Schorr:
You know, the role of a care partner such as yourself, a sister, a spouse, and other family members is so critical. Okay.
Let’s also meet someone else who has been living with lung cancer personally and that is our old friend–she’s not old, though–Janet Freeman-Daily who joins us from Seattle. Janet also happens to have the ROS1 mutation like Marisa, and she is so active in going to medical conferences all around the world. Janet, thanks for being with us.

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Janet Freeman-Daily:
Thanks for inviting me, Andrew.

Andrew Schorr:
Okay. And, Janet, you–how many conferences have you spoken to that are medical conferences, but you’re a patient who gets up and says, here’s our perspective? How many?

Janet Freeman-Daily:
I think it’s five or six at this point.

Andrew Schorr:
I bet. And we’re going to get–we’re going to talk more about the importance of that. So you’re one side of the coin, as is Marisa, and then we have a leading cancer researcher joining us from Mass General in Boston devoted to people with lung cancer. That’s Lecia Sequist. Dr. Sequist, thanks so much for being with us.

Dr. Sequist:
Thank you for having me. This is really a treat.

Andrew Schorr:
Okay. So you’ve been at medical conferences where you’ve heard people like Janet speak. Does that inspire you when you are actually at what would otherwise be just thousands of cancer specialists, but the patient perspective is put right front and center?

Dr. Sequist:
It’s very inspiring, as I’m sure we’ll talk about. It was especially palpable this year at the World Lung Cancer Conference in Toronto just about five or six weeks ago. Janet was there. There were so many lung cancer advocates there, and this is a conference that’s focused only on lung cancer, and it was really exciting.
But I would say Janet and I have been running into each other at the hallways of medical conferences for many years, and it is always really interesting to get the patient perspective about a big result that was just presented maybe an hour earlier. And I love running into people at meetings and talking to them about it. It really helps inform our research.

Andrew Schorr:
That’s what I was going to ask–go ahead, Janet.

Janet Freeman-Daily:
It’s also very nice to run into a doctor after a presentation and say, what did they just say?

Andrew Schorr:
Right. Right. So do you, Dr. Sequist besides inspiring you, and then there are people in labs who don’t even–you see patients, but there are other people who are only in labs, do you feel that this communication with people who are living it can actually help get information, promote collaboration and accelerate us towards what we hope will be cures?

Dr. Sequist:
Oh, absolutely. It’s a really vital two-way communication road. I think having patient advocates learn more about the research process, both the pros and cons about went research process, and see what all is involved and what hurdles we have to deal with all the time as researchers can be really helpful. We need their help advocating to get rid of some hurdles and the obstacles in our way.
And there is nothing more informative than finding out what really is important to patients, especially when you’re developing a new treatment, hearing from them about what they value, what they–you know, someone who is not living with it may think that a certain side effect is a big deal, yet someone who is taking the medicine will say, you know, actually that’s–I can deal with that if it’s going to help me live longer. And finding out where that balance lies is really important and not something you can just guess if you’re not in the shoes of a patient.

Andrew Schorr:
So, Marisa, you’ve been every step of the way with your–rather, excuse me, Jessica.

Jessica Wittebort:
I’m channeling her, it’s fine. I’m channeling her.

Andrew Schorr:
All right. You’ve been with Marisa every step of the way, and unfortunately she was diagnosed in 2015 at what, age–

Jessica Wittebort:
She just turned 30, yeah.

Andrew Schorr:
She just turned 30. You’re her big sister. From the family perspective what do you hope, with closer collaboration with researchers, practitioners like Dr. Sequist, what do you hope?

Jessica Wittebort:
Well, gosh, I think we’re really just hoping to expedite research, and we want to be part of that journey. You know, I think when Marisa goes in to see her oncologist and he gives her a high five because she’s doing well, you know at a granular level that that relationship and that everybody is pushing for the same thing.
I think a little bit that gets lost in translation sometimes when you can get swallowed by the information that comes out of a conference if you’re not carefully, right, so learning how to translate that information into something tangible and consumable and being able to respond back to your healthcare professionals I think is just that bridge that’s essential to moving things forward.

Andrew Schorr:
And you’ve been to some conferences. I saw you at the Biden Cancer Summit, which had a lot of patients and patient advocates there, but I think you’ve been to–where did you go? To Austria or someplace?

Jessica Wittebort:
Yeah, I went to World Lung in Austria, to meet Janet, frankly. No, I mean, to see some incredible work in progress and some incredible work, and it’s a tremendous amount of content. I probably understood, you know, 5 percent of it, but at least it got me there starting to understand what the language was, starting to understand what the potential impact of clinical trials are, starting to feel just a tremendous amount of hope that lives through science, and to see my colleagues. You know, Janet is pretty much family, so I think these conferences, it’s incredible when patients not only part–you know, really participating, I think that’s a big deal.

Janet Freeman-Daily:
It was also really great for the–there were several ROS1ders there, people who had ROS1 cancer dealing with it at the end of conference, and we got to go up en masse and talk to the researchers about what they were doing, which was educational for us, and I think most of them felt fairly enthused about it too.

Andrew Schorr:
Janet, you’ve spoken at some of these congresses. What do you want to say to that clinical and research audience? What are you trying to bring forward to them as somebody living now, what, four or five years with stage IV lung cancer?

Janet Freeman-Daily:
I was diagnosed seven and a half years ago.

Andrew Schorr:
Seven and a half years ago. So, thanks god, treatment, and you’ve been in a trial for a long time, has just been remarkable for you, life-extending. What’s the message you bring when you speak?

Janet Freeman-Daily:
Well, it depends on the setting that I’m in and what I’ve been asked to speak about. It’s been different topics. Once I’ve talked about value in cancer care and the cost of cancer drugs. Once I’ve talked about the research that the patients with ROS1 were doing. I’ve also talked about the importance of goals of care discussions with the doctors to talk about what our treatment options are and what our chances are of them being effective so we could make our own choices about treatment rather than having the doctor decide what we’re going to do.
There’s a lot of different topics out there that patients can share their background and perspectives on. I think one of my more favorite things is running into Dr. (?) Jean Kooey who created the drug that I’m on and that Marisa started with and that Marisa then took next. She’s the lead chemist on those designs, and we ran into her at the poster session at ASCO and she got to meet the patients that her drug (?) Inaudible, which was a really big deal for her. And we’re all kind of awe struck, fan girl, oh, my god.

Andrew Schorr:
So, Dr. Sequist, does that make a difference? Because there are maybe many thousands of people working around the world on lung cancer now, some people only in labs, and never meet a patient like with a more rare mutation like ROS1. Does that make a difference when that connection can happen?

Dr. Sequist:
Oh, absolutely. I do think it’s really important for people who are working on the basic science aspects of cancer and in a laboratory, a little bit removed from the patients, to meet patients and survivors and see what their work is leading to. At Mass General we routinely have tours of our lab so that the people that work in the lab, not just the lead scientists but even the techs who are there for 10, 12 hours a day working hard for them to see how their work can really make a difference. And I know lots of other centers will do that as well.

Andrew Schorr:
So we’re getting into this age of personalized medicine, and I was in Boston a week or so ago and whether it’s out of MIT or your partners group in Boston, there’s all this computing power coming into play to try to understand what is our personal situation with a cancer and how do you develop or do you have medicines or trials that line up with that. And that’s been a real work of yours, right, is to try to look at the subsets of lung cancer. How are we doing in that? We talk about ROS1 and you have KRAS and ALK and EGFR and all these different types and then some types that haven’t been identified yet, right?

Dr. Sequist:
That’s right. I think if you take the long view and look at 10 or 15 years ago where the field of lung cancer was, it is a totally different landscape today. We have come so far in being able to personalize not only the clinical trials that are available for patients but then subsequently the approved treatments. And there’s been a lot of exciting advances in lung cancer that are a little bit less personalized lately, specifically immune therapy. That works with a bit of a broader brush, but the success in the personalized targeted therapy is unparalleled in other tumors types at the moment, and so I think everyone that works in lung cancer is really proud of how much the field has moved forward.

Andrew Schorr:
But you’re doing detective work, so some of these genes weren’t originally identified, and you have probably a lot more to go, so what’s going on now where for people where a gene wasn’t identified maybe you’ll have that? You’ll find out what the factors are or if somebody switches from one driver gene to another?

Dr. Sequist:
Yeah, there’s a lot of important things that go into that. One is being able to test each patient, and there are now several ways that you can test for the key mutations. The gold standard is still testing tumor biopsy, but liquid biopsies are also coming really into the forefront ready for prime time. Janet and I actually collaborated–well, Janet led the collaboration on an article that we wrote together about liquid biopsies and how it’s–and demystifying some of these things for patient audiences.
But looking at the tumor is important, and then actually important is getting patients to the right trials. You’re not going to be able to prove that something works if you can only find one patient with that mutation. You really have to reach all over the country and sometimes all over the world to find patients specifically for a situation. And that’s one area where patient advocacy groups have been extremely helpful helping bring patients together with the trials that fit their situation.

Andrew Schorr:
So tell me–go ahead. I was just going to–Janet, what’s the message then to people watching so that they can get the care or the testing or help involved to push research further? What do you want to say to people?

Janet Freeman-Daily:
Well, I think one of the valuable things that Lecia brought out is that we are developing or identifying new mutations all the time. When I was first diagnosed nobody knew about ROS1. It hadn’t even been published yet. And when I found out about it and I brought the article to my local doctors in the community setting they didn’t know how to test for it. And yet when I got tested and they found that I had ROS1 I have been on a drug now that I’m coming up to my six-year anniversary for my clinical trial, and I’m still no evidence of disease.
So what I would tell people is it’s really important to keep track of the research and to stay on top of the new developments. And so the patient communities are really good at that because you might find a new option that didn’t exist when you were first diagnosed.

Andrew Schorr:
And so that’s something that you, Jess, and your sister do all the time, right? And so you know you have this ROS1 version of lung cancer for your sister, you don’t know if something will change or other factors will come in, so you keep your ear to the ground very much and connect with the community.

Jessica Wittebort:
Absolutely. So tactically what do we do? We have our Google alerts always set to any medicines that we’ve heard about, any clinical trials that we’ve heard about, any researchers that are working in the space. For us, we have a ROS1 community online which is–we have a public one, and we also have a private one on Facebook where we’re able to just very openly bounce ideas around and talk about things we don’t understand and get those concepts in our heads.
And oftentimes those relationships lead to actually meeting off line. So most cities that Marisa or I visit for whatever reason, whether it’s going to see a doctor or going to an event, we get to meet somebody offline as well. So finding–keeping your ear to the ground, yes. We have great luxury of really–Marisa has a great team, so they will always drive that for her. But I think it’s also something that she is always very keen to share the information that she’s getting so that other people are privileged to have that information as well.

Andrew Schorr:
Go ahead.

Janet Freeman-Daily:
And a few key researchers like Dr. Sequist, Dr. Camidge, Dr. Shaw, at a few key universities are the experts in some of these driver oncogenes, and they’ve been very generous in their time in allowing us to e-mail them questions and say, gee, this question came up in the group, and we don’t have any experience with that. Could you give us an idea of what to do? So the researchers are key to this.

Andrew Schorr:
They are. And, Dr. Sequist, thank you for your devotion. I have a question for you, and that is most people though don’t get treatment at University of Colorado or Mass General or Dana-Farber or City of Hope or MD Anderson, and we could list a bunch of the leading institutions. Most people are told they have lung cancer, they’re at a community oncology practice, they’re terrified, and you’re leading change. You’re on the leading edge, all of you, in lung cancer, but that sometimes hasn’t quite–I don’t want to say trickle down, but you’re on the podium at World Lung or ASCO and you’re talking to a thousand doctors sitting there and we’re hoping that it gets to them, and a patient walks into their clinic, though and maybe some of this isn’t brought to bear.
What can the patient or the family member do so that this knowledge that’s emerging in lung cancer can be brought to bear at the community level? What’s the patient or the family member’s role today?

Dr. Sequist:
I think medicine is changing, and we are no longer in an era where any one doctor can know everything about medicine. I mean, we haven’t been in that era for a long time. And it’s very difficult to be a community oncology, a general oncologist today. There are so many new treatments and new genes and new strategies coming out for every type of cancer in rapid succession, so keeping up with all of lung cancer advancements plus all the other tumor types is quite a challenge.

That’s why I think that now more than ever as cancer gets so complicated it does work really well for patients to be able to connect with other patients and lung cancer specialists online, through activities like this, through many other educational activities that are available and advocacy groups because–just because a community oncologist has never heard of ROS1 I don’t think makes them a bad community oncologist, but hopefully the message is getting out to the community to partner with super sub-sub specialized academic centers if a mutation like this is found in a patient.
Andrew Schorr:
Okay. So, Janet, what do you tell people, what do you want to tell our viewers who were probably treated at least initially at a community center and they have no clue whether they have some subtype, rare or not, of be lung cancer and what to do about it? Janet, (?) Inaudible.

Janet Freeman-Daily:
If a person has lung cancer and it’s non-small cell lung cancer you should have gotten genomic testing at some point, and if you didn’t you need to ask your doctor about that. If your doctor is not familiar with it, and some of the general practitioners and community oncologists may not be as comfortable with it as other lung cancer specialists, then get a second opinion, preferably at a major academic cancer center.
If you want to learn more about this there are a large number of online patient groups where you can ask questions and get educated about this, or you can go to websites of some of the lung cancer advocacy organizations like LUNGevity, Lung Cancer Foundation of America. They have a good deal of information where you can start learning about things to get yourself educated on the topic. It’s–I still hear patients who are stage IV lung cancer, and their doctor sent them home on hospice without ever doing genomic testing. It’s really important that you make sure you get the tests that are in the standard of care.

Andrew Schorr:
So, Dr. Sequist, just back to you. This genomic testing is to see, is there an oncogene or cancer gene that’s driving your cancer that either an approved or maybe a clinical trial experimental medicine may target, right? Okay?

Dr. Sequist:
That’s correct. And, as Janet was saying, it’s vitally important for every patient that’s diagnosed to get tested at a minimum for the genes that correspond to FDA-approved medications, but there are several second-tier mutations that I believe everyone should be tested for because there are clinical trials that even if it’s not available at the community site where they first sought care hopefully it’s available someplace that’s not too terribly far from where they live.

Andrew Schorr:
Okay. So I’m sure that Janet follows this and Jess of course, can the genes change? So, in other words, in lung cancer if Mrs. Jones is seen to have a KRAS mutation, just to pull one out, early on, does that always remain what’s driving her lung cancer, or might it change and there might be a need to test again?

Dr. Sequist:
I think we’re all experts in this, so we can everybody chime in as well. If the cancer truly has a driver oncogene what that means is that every single cancer cell in the tumor carries that genetic mark. Probably the very first cancer cell that came up in the body had it, and then every daughter cell that was created afterwards carries this mark. As patients–so typically these are EGFR, ALK, ROS, MET, RET. These are the ones that we have targets for, BRAF, targeted drugs.
Now, once a patient is on a targeted drug you can think of it like evolution, like survival of the fittest. So a drug is exerting pressure on the cancer, many cells are dying, but sometimes a cell will have a certain characteristic that allows it to live through the drug treatment, and then from there a resistant tumor can grow. And so second mutations or second pathways can become activated after patients have been treated with certain drugs. And the more drugs that people have been exposed to over time the more different subpopulations that might have varying signatures come up.
But you never lose that original mutation. It’s something that is always carried forward. It’s just what else piles on top of it across the different arms. I describe it as different arms of the family or cousins. Like this tumor is a cousin of that tumor because they do have some different characteristics but still that same core characteristic.

Andrew Schorr:
And you were saying about retesting?

Janet Freeman-Daily:
So some drugs we know that if they stop working there’s another drug that you can go to, but as we develop more and more drugs and EGFR, with which Dr. Sequist is very familiar, has more drugs than the rest of us. When patients take certain of those drugs second or third line they actually might develop a different mutation and will have to get retested to find out how to treat that. We’re right on the forefront of learning about how the genomics of cancer works, and we learn new things all the time.

Andrew Schorr:
So, Jess, you and your sister have sought out eminent specialists at major centers, but, as you said, not everybody goes there. What advice do you have to patients and family members, especially family members because sometimes the patient is so terrified just being led through care and the family member has to pick up the mantle? What would you say so that the loved one gets the best care?

Jessica Wittebort:
For us the most profound change has been to find a specialist at an academic institution. I think if you don’t–if you’re not able to do that, it is really important to find your patient group and start asking, what are they doing. What information can you get your head around? And keep your head above water because I really do believe there’s so much hope and there’s so much energy right now and momentum in this space that it’s important to just keep finding, keep looking for the information. And if you’re not getting the answers that you need or are too complicated figure out a way to not feel shy about asking again.

Andrew Schorr:
Amen. So you mentioned earlier, Janet, about getting tested, right?

Janet Freeman-Daily:
Yes.

Andrew Schorr:
So what if the test doesn’t identify anybody? Should they be forlorn? I’m going to ask Dr. Sequist, too. If one of these genes that we rattled off doesn’t show up or driver gene should they say, oh, my god I’m out of luck?

Janet Freeman-Daily:
No, not necessarily. Targeted therapies are easy to take in that you can take a pill once or twice a day, but they’re not the only new therapy that’s come out, and most of the patients who do not have a targeted treatment can take immunotherapy. That’s the new standard of care, and it works really well. I’ll let Dr. Sequist talk to that.

Andrew Schorr:
Let’s understand that, Dr. Sequist. So if somebody doesn’t have any of those genes but both of you have mentioned immunotherapy, how does that work and how does that help?

Dr. Sequist:
So one quick point before we get to immune therapy is that it’s really important if you are told that you don’t have any specific mutations that you make sure that the correct panel was done. Sometimes there are small panels that may miss important genes simply because they’re not part of the panel. So the test may be negative for everything that was assayed, but it may not rule out some of these rare mutations. Like Janet was saying, her mutation wasn’t even known about at that time she had the first testing done so she had to have repeat testing. And this is a very common story. So that’s what I wanted to say about testing.
But immune therapy is–really been a game changer in cancer in general including lung cancer, but this is the idea of trying to get someone’s own immune system so attack the cancer. Our bodies are supposed to do this. Our immune system is supposed to be on surveillance for cancer cells, treat them as foreign and destroy them, but obviously if a tumor grows to a point where you’re getting a diagnosis of cancer something has gone wrong in that process. Usually it is that that tumor is camouflaging itself in some way from the immune surveillance, and some of the new treatments that have been approved over the last couple of years in multiple types of cancer essentially rip off that camouflage, allow the immune system to see that the cancer is there as a foreign invader and start to attack it. In lung cancer this works best on the, as Janet was mentioning, the type of cancers that don’t have a driver mutation, the types of cancers that are more often associated with a history of smoking or exposure to some other carcinogens, and immune therapy has really changed the survival and the treatment options for a large population of lung cancer patients.

Janet Freeman-Daily:
And I just want to reiterate that it’s very important that you get genomic testing before you start immunotherapy because the data we have now indicates that immunotherapy usually does not work for those of us who have driving mutations.

Dr. Sequist:
And it may increase the toxicity of some of the targeted drugs, so not only may it not work but it might harm your chances of having a nice, long response like Janet and Marisa are having.

Andrew Schorr:
Hmm. This is complicated stuff. We talked about how difficult it is for the community oncologist who sees sort of all comers to keep up with this. Let’s just review some of the things that have come up recently at medical meetings that you’ve been at.
So first of all, Janet, from your perspective as a patient, you go to the World Lung meeting, you go to some of the other meetings, what do you think are the big deals for patients? Is it more genes being identified? Is it having immunotherapy work for more people? What are the big take-home messages we should review for people here?

Janet Freeman-Daily:
Well, you touched on two of them. One, there are more genes identified. I’m not sure I’ve got quite the right percentage, but at the moment I believe it’s about 70 percent of patients with non-small cell lung cancer have a driving mutation for which there’s an approved drug or a clinical trial. Is that right, Dr. Sequist? About?

Dr. Sequist:
I don’t know the exact number, but it’s got to be close to there.

Janet Freeman-Daily:
And then there’s immunotherapy, which not only works for some people who didn’t have treatment choices but in some cases continues to work after they stop taking the drug for a good period of time.
But I think one of the other big notes is it appears that immunotherapy may be working for small-cell lung cancer, which has not had a new treatment option in decades, so that is huge.
However, in addition to treatments I would say the next big thing, and it’s not too surprising I’m going to say this because this is what I talked at World Lung, but the fact that we have new patient groups forming around these driving oncogenes, we have enough patients who have been taking these targeted therapies enough, long enough and feeling good enough that they’re becoming active as advocates.
And they want to learn more about their disease, so we now have a group for ROS1 called the ROS1ders, for EGFR, EGFR resisters, for ALK, called ALK Positive, or RET, called the RET Renegades, and a separate group for a subset called Exon 20 group for insertions or Exon 20 of HER2 and EGFR.
And these patients groups are providing guidance to help patients find clinical trials, to help them understand their treatment, to deal with their side effects, to find experts, and we’re also funding research. So there are new research studies being funded by these patients, and the ROS1ders have actually created a study where we are making cancer models of our own rare cancer because researchers didn’t have anything to study, and now they have more cells. In fact, we’ve got, I think, four new cell lines in the past year and more in development.
And we also have three patients who have donated to creating mouse models of ROS1, and they hopefully will be useful for us. And they’ve already had two different publications on the subject. And without it some of the ROS1 research couldn’t be done, so we’re very excited about that.

Andrew Schorr:
Wow, just congratulations to all of you who are involved in this, and I know you’ve got a big smile on your face, Dr. Sequist. We used to have such a very short turn for most people with advanced lung cancer, and now, thank god, with research you’ve done and your peers around the world and in collaboration with patients we have people living much longer, like Marisa, who unfortunately couldn’t be with us today, but Janet and some others who are probably watching.
So that then gives you the opportunity to try to understand them and a lot of aspects of their care and their biology more than you ever could because people are living, right? So that chance for dialogue is really critical to understand how are we not just, yay, we have the medicines helping people live longer but what’s going on, right?

Dr. Sequist:
Yeah. I think that’s right, and it gives us an opportunity to think more critically about how we can do things differently, whereas 10, 15 years ago we were just trying it to find a way to help people live beyond a year. That was the glass ceiling that we were trying to break. And now that we’ve come so far in lung cancer we can really start looking at some of these important questions about sequencing medications, combining medications. What does that do to quality of life? What are other things that affect patients being on clinical trials for years and years, having to go through the scans and the tests? Trying to make clinical trial more accessible to people because of eligibility criteria that are obsolete.
So these are some of the lessons I’ve learned from working with patients in various forums, and it’s really very satisfying for me for sure.

Andrew Schorr:
I know a lot of your work is in EGFR, and if I have it right maybe the incidence of, if that’s the right term, of EGFR, let’s say in the Asian community is higher. Is that right? And so I know the percentage of people in clinical trials is low, like 3 percent. We need more participation of people from different groups so that you can understand how these different mutations are active more or less in different groups, right, and how certain medicines come into play? That’s one of the collaborations we from all groups need to do with you, right?

Dr. Sequist:
Well, I think another–that’s absolutely right, and another really important role that patient advocates can play is to educate their peers about what clinical research involves. Many people in this country are just scared about clinical research. They don’t want to be considered as a lab rat, and they think that’s something maybe for at the very end of the line when you’ve exhausted all other options when in fact some of the most promising clinical trials these days are for the very first treatment that you may take as soon as you’re diagnosed. And having people be aware that clinical trials are not just a way to experiment on a patient but to really offer the patient cutting-edge treatment that they couldn’t get outside of a trial and work together to bring new treatments to approval, that message is critical to get out to the public.

Andrew Schorr:
Right. And can accelerate medicines getting to the goal line quicker, right? I mean, Janet, I know you–a lot of what, for the community living with lung cancer, like you don’t know how long your ROS1 medicine will work.

Janet Freeman-Daily:
That’s right. It won’t last forever. I will eventually have to try something else, and the drug that I take will probably be in a clinical trial. I think it’s important to know that especially for those of us with driving oncogenes but also for people with cancers that don’t have a good effective treatment option, clinical trials may be your best treatment option. Clinical trials provide hope. There’s no guarantee that they will work, but when you don’t have any other option that looks effective or that lasts a long time clinical trials can be very useful.

Andrew Schorr:
So, Jess, a lot of times a physician will say to a patient, well, I might have a clinical trial for you and the patient comes home to review a whole stack of (?) legalist documents to try and simple–and the family member says, oh, no. What would you say to family members too about this idea of clinical trials and supporting your loved one in maybe getting tomorrow’s medicine today?

Jessica Wittebort:
I think it’s really important again to find a group of people that are on a clinical trial so you can see how real it is, how okay it is, you know, sort beat down those major misunderstandings, you know. Fears that you’re going to be given a placebo and then you’re left to go or whatever the case is. I think we’re still getting in a place where (?) ct.gov or Cancer Commons are able to really very clearly articulate it. The research is there, the information is there, but I do find it still a bit daunting for people who probably are just freshly diagnosed to understand what it means, so I think–

Andrew Schorr:
Right. As Janet said, there are people who can help you with the lung cancer groups she’s rattled by, online groups. There are all sorts of people who can help you, so I want you to–I hope our viewers will take advantage of that.
So, Dr. Sequist, people–Jess just mentioned about people have this fear of getting a placebo. If you’re in a trial, people want to get the good stuff even though you’re not sure what the good stuff is or how good the good stuff could be, but are they taken care of no matter what?

Dr. Sequist:
Patients are absolutely taken care of no matter what. There are many different kinds of clinical trials. Some of them have one arm where everyone on the trial gets the same treatment. Some of them may have multiple arms, and there could be a randomization where a computer basically rolls the dice and tells you and your doctor which arm you’re going to be placed in and you don’t have a choice. But patients are informed about the design of the trial and the various treatments before they sign up. We’re still–scientifically, before something can become standard of care, we still need to compare it to the old standard of care. Luckily, in lung cancer there really aren’t too many spaces left where standard of care would be placebo, so most patients getting lung cancer clinical trials are treated with a standard chemotherapy or a standard targeted therapy or a standard immune therapy, and then the experimental arm might be a variation on that or something totally different.
But it’s really important, and if you do participate in a clinical trial the person who is talking to you about the participation and getting your consent will inform you of all those things. What are the options? What could you be treated with? What is the purpose of the trial? How will it help you as a participant? These are all really important things to understand before you jump in.

Andrew Schorr:
Here’s a question–oh, sorry. Please.

Jessica Wittebort:
I was just going to say that Marisa just signed a stack of papers in Boston this week for participating in the blood biopsy trial, and that’s maybe the fourth pile of paperwork I’ve seen her sign. And it was an incredible process of just her being able to ask any questions, the nurse practitioner sitting down with her answering, answering everything and anything and understanding what it meant. And, you know, it’s–I just think we probably need to figure out how to eliminate some of the fear and the mystery around that process.

Andrew Schorr:
We did a program the other day and the replay will be posted soon with Dr. Richard Schilsky who is the chief medical officer of ASCO, the big cancer organization, and they’re really working hard with industry and government to simplify the forms. And, for instance, for people where English is not their first language to make sure that things are explained to you in your language, whether you read or if there’s a translator there so that you fully understand.
Here’s a question we got in from Ed, Dr. Sequist. He says, I’ve been an active participant in a Phase 1 trial for nearly three years. What is the average length of time it takes for a clinical trial to get to FDA approval?

Dr. Sequist:
That can really vary. I don’t think there is a standard answer, but a lot of people ask me, okay, doc, I’m going on to this Phase 1 trial at what paint will I be graduated up to Phase 2 or Phase 3? And, you know, patients usually don’t switch from a Phase 1 trial to a Phase 2 or 3. The drug development may continue and–continue on its pathway towards FDA development, but patients usually stay in the same trial that they started on.
The record time in oncology for first patient dosed–interval between first patient dosed in a Phase 1 trial to FDA approval was probably for crizotinib, which is an ALK, ROS and MET inhibitor, where the time was, what, about three years, Janet?

Janet Freeman-Daily:
Inaudible.

Dr. Sequist:
But most drugs take a little longer than that. But when I was training the–what I was taught was that it usually takes 10 years for a drug to get from Phase 1 to approval. Thankfully, that is not the case anymore. Most drugs are getting there in three, four, five years.

Andrew Schorr:
Well, I think, as Dr. Schilsky said the other day, they’re really trying to work with the FDA, the NCI, industry to try to do it, but part of it–now, for instance, the government is looking for patient-reported outcomes. How do things affect the patient in their life? So again doesn’t that come into play, too, Janet, that we need to be–we need to be not just part of the trial but we need to be giving information to help with as decisions are made about whether a new drug is a big deal, right?

Janet Freeman-Daily:
Yeah. Patient-reported outcomes are just starting to be incorporated into clinical trials, and it will be great to have them more involved and for patients to be able to provide inputs that are important to them about how they feel on the drug and how it affects them so that we will have more information about side effects when a drug gets approved. But it’s still fairly early.
But I want to go back to one thing that Dr. Sequist said, that the FDA is trying to put programs in place that will help get drugs approved faster. So the clinical trial that I’m on has been going for seven years and will keep going even though the drug is already approved because the drug was approved under what they call accelerated approval based on a Phase 1, 2 trial. Usually the FDA used to require that you had to have a big Phase 3 trial with hundreds of people where you compare the drug against the current standard of care and get a positive result before you could get the drug approved.
But now they’re making drugs for small populations like ROS1 patients. We’re 1 percent of the non-small cell lung cancer population, and you’ll never get enough of us together in one place to do a Phase 3 trial. So the FDA has something in place that allows you to approve drugs based on the Phase 2 trial. Everybody in this Phase 2 trial knows they are taking crizotinib. There is no placebo. So there are–the clinical trials are evolving.

Andrew Schorr:
So, Dr. Sequist, let’s back up for a second. So we’ve had–we have these meetings that you all go to, World Lung meeting, which was in Toronto I think a few months ago. And you have the ASCO meeting and others you probably go to around the world. What do you think is a big deal now? And I know I’ve seen you on the podium at some of these meetings. What do you think is a big deal for patients if you take away from some of the key studies that have been–you’re releasing data on?

Dr. Sequist:
It’s been a huge year for lung cancer. I mean, the standard of care has changed in lung cancer in almost every little corner that you look in. A year ago or certainly two years ago most patients who were diagnosed would get chemotherapy as the first pass treatment. If you happened to have one of the driver mutations then you would try and get one of those treatments first.
Now the standard of care has completely changed. Most patients get immune therapy with or without chemotherapy. There are new approved drugs for ALK and for EGFR in the frontline setting. There’s a new standard of care for stage III lung cancer which we haven’t had in 30 years. There’s a new standard of care for small-cell lung cancer which we haven’t had in 30 years. There’s more evidence from this past year about screening for lung cancer with low-dose CT scans and how this is really effective at diagnosing people earlier and saving lives, potentially especially so in women, we learned at World Lung. So every corner of lung cancer that you can shine a light into there’s been advancements over the last one to two years. It’s really quite amazing.

Janet Freeman-Daily:
We’ve also had one liquid biopsy approved where they can use a blood test to determine whether you’re eligible to take a certain kind of drug. That just happened last year I think.

Andrew Schorr:
So, Jess, you listen to this as a family member. What hope do you take away from that for your sister? Jess, could you hear me okay?

Jessica Wittebort:
Yes, sorry. You’re breaking up a little bit, Andrew.

Andrew Schorr:
I said you hear what Janet and Dr. Sequist were just saying. What hope can you take away from this because you worry about your sister of the week?

Jessica Wittebort:
Every single day I worry about her. And she has to worry about me as well. I often wonder who the real carer is. But, frankly, it’s, you know, she was given a brutal diagnosis three years ago, and she’s kicking. You know what I mean? She’s kicking. She’s doing great. She’s doing yoga teacher training. You know, she has good days and bad days, and I just think there’s an incredible amount of hope.
So get your head in the game, get some information. Get yourself a plan, and you move forward. And if you don’t find the doctor, and it happens all the time, can’t find the doctor you can trust or you can get the right answers from, then you keep looking.

Andrew Schorr:
So here’s some questions that we’ve got in. And, again, if our viewers have a question just send it to questions@patientpower.info.

Kevin writes in for you, Dr. Sequist, for many cancer patients there’s a learning curve. What are your thoughts on how a patient might know when they’re ready to learn and what are the first-stop resources that might give them education they’re ready for? And, Janet, I’m sure you’re going to weigh in. How about the ready to learn? Because otherwise at the beginning you’re drinking–you’re terrified, and you’re drinking from a fire hose?

Dr. Sequist:
Yeah, that’s a great question and I don’t think it’s one-size-fits-all. I mean, patients, it’s like all of us. They come with much different preferences about how they like to learn, about what they want to know, about whether they want to be the primary person learning things or they’re going to designate a family member to help them with this information.
Some people like to learn on the internet. That can be tricky because there’s a lot of bad information on the internet in addition to a lot of good information on the internet. Some people aren’t that into the internet, and they need to learn in-person or through meeting people or phone calls. Luckily, the lung cancer community has so many support systems and education systems that are out there.

Janet mentioned a few, LUNGevity and the American Cancer Society has some information on their website, but a lot of academic medical centers also have information on their websites about lung cancer and resources to connect you to learning more when you’re ready.

Janet Freeman-Daily:
So just to add to that, because there are a lot of wonderful, very educational resources on the internet the Lung Cancer Social Media group put together a reference page for vetted online resources. So if you go to lcsmchat.org under resources and look for what’s there you can find a list that includes links under various categories like for those who are newly diagnosed or looking at lung cancer screening or whatever. And on that list we’ve tried to pull a sample from all of the various pages we know of, all the various organizations that have good lung cancer information. So you can start there.

Andrew Schorr:
Dr. Sequist, I wanted to call out small-cell lung cancer, which I know is the minority of lung cancer. And Janet referred to immunotherapy there, and you talk about overall about hope. Where are we with small-cell now?

Dr. Sequist:
Well, there was a very exciting presentation in Toronto at the World Lung meeting and it got published in the premier journal, The New England Journal of Medicine, that same day that set a new standard for small-cell lung cancer, something that–it was actually really moving. The whole audience burst into applause and cheered essentially when this result came up because for most of us in the audience we had never witnessed an advance in small-cell lung cancer in the course of our career. So this advance is taking the standard chemotherapy for small-cell and adding immunotherapy to it, and patients had an improved survival when that happened.

Andrew Schorr:
Okay. So where do we go from here? Janet, you’re living with it. You wonder how long your medicine is going to work. You have one rare subtype. Other subtypes are being identified and then other people

where it hasn’t been identified yet. What do you want to say to people as far as just keeping on keeping on, if you will, and the importance of a dialogue with a doctor, a researcher in partnership?

Janet Freeman-Daily:
I think the only thing I would make sure everyone does, no matter whether you want to know all the details, whether you want to be involved in research is that it’s essential that you tell the doctor what is important to you. They can do all the rest of it if you need them to, but they can’t know whether it’s more important to you to try every last treatment no matter how lousy you feel, or whether you would rather make sure that if you can’t get out and walk in the woods then life isn’t worth living. They won’t know if you don’t tell them, so it’s important for you as a patient to start thinking about what matters to you in terms of your treatment.
Likely, you’ll be on more than one treatment at some point if you have metastatic lung cancer, and you need to know whether the side effects are acceptable to you. So even if you don’t want to do the research at least be able to tell the doctor what matters to you. I hope Dr. Sequist that you get some patients who do that.

Andrew Schorr:
So, Jess, so some people have trouble speaking up for themselves. I don’t think you’re sister is that way, but you go with her to a lot of treatments and visits. What would you say to family members to support their loved one, and if their loved one isn’t, isn’t feeling strong enough to speak up that the family member has permission to do that and that it makes a difference.

Jessica Wittebort:
Yeah, I think Marisa has her boyfriend, my dad, (?) Inaudible happy to hem and holler about the questions we have and the questions that she raised since the last time we saw the oncologist. But more recently she referred to us as the peanut gallery. I think she’s, you know, at the beginning of this diagnosis I was the one that reached out to the ROS1 group, and now she has a pleural effusion and she’s trying to figure out all the places that that pleural fluid should go to support research.
So I think that the journey will change. I hate that word, journey. I think the path changes as you go. You know that old when you come to a fork in the road, you can take the path or whatever it is, and I think you just have to figure out how to be flexible and flex with that journey. There was–one of the really nice pieces at the Biden Cancer Initiative, I’m terrible with names, the athlete was talking about, you know, everybody talks about diagnosis and the shoot for the cure, but it’s that middle, it’s that middle part that is so tenuous and you have to get really comfortable with the uncomfortable middle part.
So I think, gosh, it could be a strain and stress on your loved ones, and I think the communication is just one must of the exercise as you go, and if you can figure out how to lean into that as a carer, as a patient, as a loved one, then you’re probably ahead of the curve.

Andrew Schorr:
Thank you for that, and we wish your sister all the best, Marisa. My last question is for Janet and then Dr. Sequist. So it used to be the doctor was in the white coat, and the doctor said we’re going to do this, and you were scared, and you went down the hall to have a scan or this or a biopsy, whatever, you just did it. You’re just sort of literally the walking wounded, and you and your family were terrified. And whether you understood or not you sort of nodded your head, and that’s what would happen.

Dr. Sequist, do you welcome the change? Do you welcome the change that we’re sort of all in this

together? And I don’t mean just physicians but I mean researchers too, that this feeling that the patients, the family members, that together, we can solve things. Alone, it’s slower or more difficult?

Dr. Sequist:
Oh, yeah. It’s a very welcome change. I’ve gotten a lot of information and education as well as satisfaction from participating in the lung cancer social media group that Janet mentioned. It’s really great to be able to connect with people on Twitter who are researching lung cancer around the world or who are patients living with lung cancer around the world. And it’s a way to get lightning-fast updates about conferences, and everybody working together towards a common goal is a good feeling to be in that pack.

And I would say to patients out there if you’re in a relationship with a provider where it feels more like what you were describing, Andrew, like that you’re just being told what to do and you’re not being listened to or you don’t have the ability to speak up or have your loved one speak up for you, you need to seek out a different oncologist. Because it’s too important.
It’s too important of a disease to be dealing with someone you don’t have a great relationship with. And I would define a great cancer patient/oncologist relationship is one where both people can feel free for express what’s on their mind and to listen to each other and just feel heard and feel part of the decision-making.

Andrew Schorr:
I just think has a tragedy if, as you say, the landscape is changing so much–we have a long way to go, but it is changing so much in welcome. What a shame if you or your loved one passes away because there wasn’t a certain test done or a wide enough panel testing and there was something either approved or in trials that could make a difference to extend life. What a tragedy.
So Janet, I’m going to leave the last sort of empowerment message to you, what you want to say to people so that that doesn’t happen.

Janet Freeman-Daily:
I think there’s been a lot of good comments in the entire presentation along those lines. I think there’s a lot of evidence to show that engaged patients with serious diseases live longer. That patients who become more educated about their disease when it’s on the cutting edge as lung cancer is right now, they have a much better chance of making sure that they’re getting the best care.
But I also want to point out one interesting thing that’s evolving as we get these more empowered patient groups. We actually had a doctor, a researcher approach us because he had heard that ROS1 patients supposedly didn’t have as many brain mets as outpatients did, and that didn’t seem right to him. So we actually worked with him and did a survey on our own patient group and were able to tell him, yeah, it’s a lot more common than people are giving it credit for, which stimulated a whole new path of research that’s changing the way that people think about the disease. And if we had not had that open communication between the patients and the researchers, if we hadn’t had the empowered patient groups that survey wouldn’t have happened. So I think this change in paradigm being patients learning about their disease and getting involved in patient groups is making a huge difference.

Andrew Schorr:
Well, Janet Freeman-Daily thank you for being with us once again. I hope we get to do this for years and years, Janet, and one day we can say cured. Wouldn’t that be great? And I’m so delighted to see you and for joining us.

And Jess Wittebort, thanks so much for being with us too. All the best to your sister Marisa with the procedures she has, and, as you say, she’s kicking it, and I hope that keeps happening.

And Dr. Lecia Sequist from Mass General, thank you for your devotion to patients and helping lead the way in research so that we can really everybody can get the personalized care they need.
I’m Andrew Schorr from Patient Power. Remember, knowledge can be the best medicine of all.


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