MS. SANDRA SHAW:Welcome to CURE's Educated Patient webinar, "Know Your Lung Cancer: Accelerating Education and Access for Biomarker Testing."I'm Sandra Shaw, Lead for Patient Advocacy for Partnerships and Engagement here at CURE.We're pleased to bring you this webinar presented by CURE and in partnership with Amgen.

We have a few important announcements before we begin.We encourage you to ask questions during the event which you can submit by typing them in the Q&A box.You'll be receiving a survey via email tomorrow.As a thank you for watching the full webinar and completing the survey, you'll be entered to win one of three Visa Gift Cards.

Today, I'd like to welcome our panel.We're pleased to be joined today by I-Fen Chang, Executive Medical Director of Global Oncology at Amgen; Andrea Ferris, President and Chief Executive Officer of LUNGevity Foundation; Dr. Eric Konnick, from the University of Washington, Association of Molecular Pathology; Claire Saxton, Vice President of Education at Cancer Support Community; and Bob Smith, Epidemiologist and Vice President of Cancer Screening at the American Cancer Society.

Biomarkers have revolutionized lung cancer treatment, leading to precision medicine for each patient’s cancer. We're here to talk about the importance of biomarker testing and the challenges and opportunities in the areas of awareness of biomarker testing, improving coordination of care and removing barriers to access as well as potential solutions.

Now we will hear from Juanita, a lung cancer patient who went through biomarker testing and found out she is ALK-positive. She’ll talk about her experience getting tested for biomarkers and how her doctor changed her treatment plan based on those results.

Juanita's Video

MS. JUANITA SEGURA:Hi there, my name is Juanita Segura.Before my diagnosis, I used to work here in my city.I was in the front line in case there was a disaster.Prior to that, I did work for the Federal Government, for almost 12 years.I got married at a young age.I gave birth to five wonderful children and now, I am a happy, cheerful, grandma.My passion right now is being a grandma and being a lung cancer advocate.

I was diagnosed about six and a half years ago.I started wheezing.I just had this wheeze, and it wouldn't go away.I was getting tired and I just couldn't finish the workouts.I couldn't do anything.I was struggling.I knew there was something wrong, but I wasn't sure what.I went to go see my doctor; they gave me the inhaler.She did x-rays, she did bloodwork.Nothing came up.She goes, "It's not pneumonia.It's not bronchitis."She says, "You just have asthma."I ended up in the ER, and then, that's when they did a CT scan and they did all kinds of other tests and that's when they told me, "We have to admit you."They didn't tell me that they found a mass, a lump, they just said, "We have to admit you."

I'll never forget when my pulmonary specialist came into the room, and when he said lung cancer, I could feel myself just sinking into the ground.The feeling I got, it was fear.It was mad.I was only 46 years old.Honestly, that was the worst day of my life, was getting diagnosed with stage III lung cancer.

When I was first diagnosed, my husband did all the research.I couldn't because I was so sad, depressed, crying.When I initially went to where I had my treatments, a doctor said you need the biomarker testing because that is going to determine if you have a gene mutation.I had so many bronchoscopies done.Finally, they got enough tissue to send it to the pathologist.It took six weeks.Six weeks for me to get the report.My husband was so upset.My husband wanted it like yesterday.I ended up with traditional chemo and radiation, and then the last day of my treatments, is when I was told I was ALK-positive.At this point, I was just so exhausted from all the treatments of chemo and radiation, that I was like, okay, this is the next phase, next step.It was a great, I'm going to say breakthrough, especially in lung cancer, to be able to go in, get tissue samples of the tumor and send it to the pathology.I was happy because I knew that there was treatment.Yes, a diagnosis of lung cancer is devastating, but to find out that I was ALK-positive and possibly meet my granddaughter, which I did, it was absolutely amazing.I was ecstatic.I was happy.I was thankful, and I was so grateful.

The first thing I tell them, I say, "Did the doctor, or your oncologist, mention biomarker testing?"If not, I tell them, "Write it down."When you go back into your oncologist or your doctor, this is what you're going to ask: biomarker testing, because it's going to determine if you have a gene mutation or not.Make sure you get that biomarker testing done, 'cause if you do have a gene mutation, then you could get on targeted therapy, but it's very, very important; research, do your homework.Write some questions down and bring it up to your doctor.

It made me stronger.It made me a fighter.This journey has showed me to be patient, to be still.It has shown me that don't rush anything, appreciate the little things.It taught me to be humble.It taught me to show kindness.It taught me to love, to have more compassion, more empathy.It showed me peace and now, with this diagnosis, that's what it's taught me, and now, I stop.I stop and I appreciate.I breathe.I'm relaxed.I'm at peace.That's why I say I thank lung cancer for that, 'cause it made me this amazing woman that I am today.

MS. SHAW:Juanita’s story gives us a window into the real patient experience and the potential challenges that some patients can face, in particular with the time it can take to receive testing results. Now I’d like to turn to our panelists to discuss what could be seen as a starting point for biomarker testing, and the importance of increased awareness.

Improving Awareness of Biomarker Testing

MS. SHAW:I-Fen, why is biomarker testing important for lung cancer patients?

MS. I-FEN CHANG:Sandra, thank you for that great question. There's been tremendous scientific advancements occurring in the last decade in lung cancer.Within the last decade, what we've seen is now, we have close to ten genetic mutations that are either emerging or already actionable.Most recently, this includes the addition of KRAS, NTRK, MET and RET.This expanded knowledge coupled with availability of targeted therapies have significantly improved the prognosis for lung cancer patients.Essentially, we're starting to move away from this one-size-fits-all approach of treating lung cancer, and really starting to enter an era of personalized medicine.While not every genetic mutation currently has an available targeted therapy, Juanita's lung cancer story and her experience with biomarker testing is an example of how comprehensive biomarker testing can help physicians potentially match the right targeted therapy to a patient, based on their molecular profile.

At Amgen, we often hear similar stories to Juanita's.What we have found is that patients are still struggling to find the right tools that can help them understand their biomarker testing status and the results.This has been a catalyst to drive our commitment in supporting three particular areas and efforts.This includes increasing awareness around comprehensive biomarker testing, helping ensure that testing is broadly available for patients, and very importantly, ensuring that these results are readily available to help guide treatment decisions between physicians and patients.

We believe that as community, we need to ensure that not only are we empowering the patients, but we also ensure that the best care is available for patients regardless of the setting that they receive the care, whether this is in a community setting or if the care is taking place in an academic center.Together with the nation's lead cancer organization, some of whom I have the pleasure to have in this panel with me today, we share a common goal which is really to accelerate education and access to comprehensive biomarker testing for patients that are living with lung cancer.

MS. SHAW:Thank you, I-Fen.Claire, Cancer Support Community is really committed to empowering patients, what have you learned at CSC about what patients experience when comes to understanding biomarker testing and some of the factors that are contributing to lack of awareness?

MS. CLAIRE SAXTON:Thanks.At the Cancer Support Community, we hear from patients that, at the point of diagnosis, whether it's a first diagnosis or a recurrence of lung cancer, patients are confused.They're overwhelmed.They hear an alphabet soup of things like MET and RET, and KRAS, and ALK, and don't really know what it means.One of the things that we're working on at Cancer Support Community is how do we best explain biomarker testing in a consistent easy way?

If your doctor says to you, "This drug targets ALK," you might have no understanding of what that means, but if we just turn it around and say, "If you test positive on an ALK test, then this specific kind of drug could be a good treatment for you.That's something that most people can understand, even if they are overwhelmed, or at least their loved ones can hear and help them understand what's going on.

In an ideal world, no patient would ever have to know all about biomarker testing, or even that it exists.The healthcare team would just take care of it and it would happen.But these are the newest treatments for lung cancer, and so not every cancer doctor that treats multiple kinds of cancer can stay up-to-date on all of the newest ways to treat each different subtype of lung cancer.

One of the things that we're trying to do with precision medicine is to figure out what subtype of cancer do you have and how we best treat that subtype.

MS. SHAW:Thanks, Claire.We know LUNGevity understands the underserved lung cancer patient treated in the community.Andrea, what insights can you share on your research and outreach to these patients?

MS. ANDREA FERRIS:Firstly, thank you for having me for the support for this.I think this is a really important topic to discuss.Just to clarify a little bit, Sandra, I don't know that anybody fully understands yet, but we're doing a lot of research to try to understand the underserved patient.Because really, in lung cancer, as we know, 80% of the cancer care is delivered in a community setting, not in an academic setting, and that's where most people access their drugs, their treatments and the testing as well.

We've been conducting a three-year study in collaboration with the Association of Community Cancer Centers, where we're trying to understand the unmet needs from the patient side, and the ACCC is trying to understand from the provider's side, so that we can create, together, information and understanding for the patient and for the provider.To Claire's point, in an ideal world, this should never sit on a patient's shoulders.We just want to make sure that information is health-literate, culturally sensitive and linguistically appropriate so that all people, who are diagnosed with lung cancer, can really benefit from the advancements in the treatments.That's where we are trying to go with this information.

I think in terms of what understanding has uncovered thus far, is not surprisingly, the biggest divide is around socio-economic status and income levels, in terms of where people get information, education levels as well, and how they access care.We're trying to provide information that's very pragmatic, of what it is, how does this impact me, how does it impact my treatment.What is it going to feel like?What should I expect?Very pragmatic questions along those lines, as well, which I think are hugely important to make sure that people have that information.

MS. SHAW:Thanks, Andrea.There's lots of good information about the community.When thinking about all of the things we've learned, Claire, Cancer Support Community has solutions for patients to help understand and navigate biomarker testing.Can you share and tell more about that?

MS. SAXTON:Sure.Cancer Support Community has launched a new online tool to help lung cancer patients and their loved ones navigate biomarker testing.You can find our tool on our website at www.CancerSupportCommunity.org/biomarker-testing-tool, and here you can see what the homepage of the tool looks like.

Anyone with lung cancer should ask their cancer care team members about comprehensive biomarker testing.But if you want to know more about which biomarkers matter for you and why, our online biomarker testing tool can give you customized information.You just have to answer a few questions about the kind and stage of lung cancer that you or your loved one has.

If you don't know the kind or stage of lung cancer you or your loved one has, the tool provides help at each question and prompts for you to learn more.

Once you answer these questions, you'll get a customized list of any biomarkers that it might make sense to talk to your cancer care team about.If you have not yet been tested or don't know if you've had comprehensive biomarker testing, the tool has tips for talking to your healthcare team about getting comprehensive biomarker testing.

If you have your biomarker test results, you can click to learn more about the particular biomarkers that you tested positive for and what your results may mean for what treatments may be best for your specific subtype of lung cancer.

In the example that we're showing on the screen, this is the current result someone with advanced non-small cell lung cancer would get after answering those few questions the tool asks.If, for example, after comprehensive biomarker testing, you found out that you tested positive for ALK, like Juanita did, you could click on that red button that says ALK to learn more about what that means for you.That then, brings you to customized information about what ALK is and how ALK-positive lung cancer is treated.Depending on how you answer the questions, the tool can also bring you to information on talking to your cancer care team, on finding a clinical trial, or on understanding what your particular biomarker tests results mean for you.

I'd encourage anyone who's interested to check out our biomarker testing tool for themselves.Again, that link is www.CancerSupportCommunity.org/biomarker-testing-tool.

MS. SHAW:Thanks, Claire, for going over that great resource for patients.Along with the extensive research you've done, Andrea, what other efforts is LUNGevity spearheading to reach out to patients and advance education?

MS. FERRIS:Thank you, Sandra.That does look like a great tool.Similar to all the organizations that are part of today's panel as well, and others, we have comprehensive education available for patients.Importantly, though, we also have health-literate versions of the education, and also, it's available in multiple languages.I do think that it's very important to reach people in ways that they can understand the information and when they need the information.In addition to that, we've established a network of community-based organizations and we're working with them to provide information in lunch-and-learns, our survivorship conferences, as well as our survivorship support services as well, can help to answer questions and to pair people up with other patients or people who have been through a similar experience, similar treatments, and disease.Because I think often times that too, is a very important venue to learn and to feel heard.

We do provide all of those things.In addition to that we also have embarked on awareness campaigns to make people aware about biomarker testing and where they can get information and support.Actually, today, I don't know if it's crossed the wire yet, we're launching and announcing a new public service awareness campaign that is multi-state - - multi-year about biomarker testing.But I do think that it's hugely important to ensure that we have information available to all people, in manners in which they can absorb it.

Improving Coordination of Care

MS. SHAW:Thank you all, for sharing all this great work that you've been doing around raising awareness and the tools and resources that you're providing to the community.With biomarker testing, really adding a new dimension to cancer care, it obviously has an impact on the overall coordination of care as well, and how a patient's clinical team really works together.Robert, we know this is an area where the American Cancer Society is focusing, what are the challenges in clinical practice, related to coordination of care, and how do they impact patients?Share with us some of the differences in the community versus the academic setting that we've heard about?

DR. ROBERT SMITH:Thank you, Sandra, that's really an important question, and I'm glad to be here.The American Cancer Society has supported a national lung cancer roundtable.It's now an organization of 150 organizations, so some of those member organizations are on this call today.Everybody appreciates the multidisciplinary care in any setting for any disease is a real challenge, but it really is critical to good outcomes.Ultimately, all of those specialists have to be prepared to deliver those outcomes.

As part of our efforts, we've placed a high priority on biomarker testing.We have a task force specifically focused on it.In collaboration with some of the advocacy organizations on this call today, we have worked with CHEST, which is the pulmonologist organization, and ASCO, and we've done surveys of their membership to try to understand some of the challenges and readiness to do biomarker testing and what their routine experiences are.

One of the things we've seen is a considerable variation in knowledge.This is a rapidly changing field and clinicians readily acknowledge that it's hard to keep up.We see variations in guidelines in current care.We see variations in the performance of testing, the adequacy of tissue collection, and variations in multidisciplinary coordination and almost a complete lack of feedback in performance.We see differences between the performance and readiness to perform biomarker testing between academic settings, and as Andrea mentioned, most importantly, community-based settings.I want to stress, it's not as if academic settings are doing a particularly great job either.They also emphasize that they face the very same challenges that we see in the community settings, and especially in delivering multidisciplinary care.

We face an enormous challenge, but I think it's a challenge that can be met, and one of the things that makes this especially important, is that increasingly, biomarker testing is not just going to be a standard of care for patients with very advanced stage disease, but we're going to start seeing biomarker testing for earlier stage disease.

MS. SHAW:That's really great to hear, Robert.What can we do to encourage the uptake of biomarker testing, for all patients, so that patients get the right care at the right time?

DR. SMITH:We've got a lot of experience accelerating best practices over the years, and I think we know many of the things that need to be done.I think the simplest thing we can begin with is to create the educational opportunities to bring the clinicians up to speed and create a climate where they will want to stay up to speed.For example, in addition to assessing the challenges that we have, as we did with these surveys, we held a biomarker summit last September, where we identified the challenges and came up with a range of solutions that we think ought to be able to make a difference, and those are going to be catalyzed in the strategic plan that will be published in Cancer and will be open-access to anybody who wants to read it.

We are, with the support of Amgen, beginning a program of nation-wide ECHOs.ECHOs are a clinical learning environment.It stands for Extension of Community Healthcare Outcomes.The American Cancer Society is an ECHO hub, and what you would do in any specific state where you launch these ECHOs, is you would identify a number of treatment settings, hospital systems, cancer care settings, and these would be your spokes.The way doctors and clinicians learn in these ECHO settings is through clinical cases.They bring their challenges and their particular cases to the ECHOs and discuss them.Usually, there's always a lecture from an expert and then the clinical cases are built around that particular topic for that particular session.The idea is that everybody teaches, and everybody learns.We will start these in Georgia, Tennessee, Kentucky, and Mississippi.These will be pilots and I imagine for the first year or so, every state that we go in will be a new pilot, as we learn more and more about how to deliver these ECHOs.We're going to bring them to all 50 states.

We also, expect to develop educational materials, webinars, but the point I want to stress here is, in these state-based ECHOs, we are going to take a state-wide model approach, where the ECHOs will continue from the larger centers to the smaller ones, with the idea that there ought to be an approach to collaboration and cooperation and networking so that the community cancer centers have an opportunity to deliver higher quality care with support from larger centers.

I think a particularly important emphasis, and I think everybody who heard Juanita's story and her very good outcome, but nonetheless was startled to hear that she had to wait six weeks for her results.That is something that everybody agrees has to be improved.We have to overcome this delay in turnaround time.We have to get it to a level that everybody wishes they had, which is less than two weeks.I think one of the factors that we also have to come to terms with, are perhaps some of the more intractable ones, which is overcoming the inconsistent insurance coverage for biomarker testing.At our summit, health plans complained that they have a hard time determining whether they should cover a particular biomarker testing or not, and there was agreement that there could be a program of actually supporting pulling together the data on the clinical and test utility of these tests to help them reach these decisions more quickly, following a standard algorithm that would be common across the industry.

I think we've got a big challenge ahead of us, but I think if we all work together, if we identify challenges across the specialty societies and get them engaged as well, we will make faster progress than we've made today.

MS. SHAW:Thank you, Robert.It sounds like you guys are doing a tremendous amount of work on improving the uptake of biomarker testing and have solutions to improve the implementation overall and coordination of care.Eric, from your perspective, as a pathologist and a critical part of the clinical team, what are some of the barriers that exist today in the coordination of care, and needs to be done to increase awareness, understanding and adoption of biomarker testing among oncology clinicians?

DR. ERIC KONNICK:I think I can echo a lot of the things that've already been said.One of the things that's always surprising to me in some ways and not others, is how fast this field changes.When I think back to about the last 18 months, even in the midst of the pandemic, we've changed our practice four or five times in how we test for and report biomarker findings, specifically in lung cancer.You know, we're in an academic setting and that's part of our mission is education and training the next generation of physicians and pathologists, and so we're on the cutting edge in a lot of ways.But I think about the challenges in the community setting where they may not have the resources and the expertise and all the other colleagues that we rely on constantly.It's hard to keep up, and how do you disseminate that information and practice up to the standard of care at any given moment.I think education is absolutely a part of the mission in order to get this out there and bring people up to the standard of care.

The other part is, again, with how things change so quickly.Sometimes how we interpret things and how we will treat things changes, and that goes for the oncologists as well, and so you're really having that communication back and forth between the pathologist, the laboratory medicine physician, the molecular pathologist, and the oncologist is critical.

Barriers, I think one of the main ones we see is consistency.We're a tertiary referral center and so patients are often treated in the community before they come to the academic setting.They've had "comprehensive testing" at the outside, based on nodes and things like that, but we've had so many patients where they didn't have a driver mutation identified outside and we repeat the testing and find something that is treatable.This is more than six weeks delay; this is sometimes years later because they didn't have that comprehensive testing.So that vocabulary of what is included in a test result is critically important, not just to pathologists and patients, but also to oncologists.Just assuming that this word means what you think it means, isn't necessarily true.

I think there's a lot of work to be done that can precure, but at the end of the day, one of the things I always fall back on, is local care is good care if you're able to have those resources in your community and have that communication between the patient, the oncologist, pathologist, you're going to have much better care and much better outcomes than if those things are disaggregated and separate.

Removing Barriers to Access

MS. SHAW:It sounds like we are consistently saying education for physicians, education for patients, awareness, is the theme throughout all of this.Based on what we've learned so far, it's really easy to see the impact that biomarkers can have for lung cancer patients.Unfortunately, there are instances when patients still have challenges.Thinking of some of those barriers to access, Eric, when it comes to actually implementing the testing for patients, what are some of the challenges?

DR. KONNICK:Again, just knowing that you need to test for something is critical and the other part of it is knowing what the best method is.We talk about these biomarkers like these are black boxes, where you send in a sample and you get out a result, but there is a lot of nuance here.I'm going to use a different method for a different finding, depending on what that cancer is, and what the mutational spectrum is and all kinds of other things.There is a lot of complexity here, and so that does cause problems.

The other thing that we find, especially when you're on the forefront of things, it's already been mentioned, is unfortunately, insurance reimbursement.We've seen patients that are absolutely a high likelihood to have a driver mutation, but their insurance coverage doesn't allow them to get the testing or they would have to pay for it out-of-pocket and they couldn't do that.We've seen oncologists basically screen their patients and decide whether or not patients get testing based on socioeconomic factors.That's a huge barrier right now.

MS. SHAW:That's unfortunate to hear some of the health equity issues that are out there.Thinking of these challenges and access issues, Andrea, outside of the major institutions in the community practice setting, a different set of challenges exists.Can you share more about what your research has shown and what you've learned in that particular area?

MS. FERRIS:Sandra, I think a lot of it has been spoken to already, between Bob and Eric.I think, as we've discussed, it's hugely important to have information available to patients about biomarker testing, but to Claire's point before, they shouldn't have to ask.The ideal goal is that this should be done reflexively, where it is a comprehensive panel where all mutations are tested for, not just for ones that have an available treatment, but ones that are in clinical trial or ones to come, too.

I think, as Bob mentioned, with respect to the payors, it's a hugely important issue not just on the commercial payor side, but Medicare and also, Medicaid.We are working with the American Cancer Society Cancer Action Network at the state level to ensure that Medicaid covers comprehensive biomarker testing as well.

It was also touched upon the multidisciplinary teams, often times in a community setting, you don't have that.Again, it becomes a policy issue, with respect to telehealth or telemedicine, not just reimbursement, but can people who specialize in interpreting these reports practice across state lines.I think that there are a lot of sort of systemic issues that need to be addressed, that a lot of us are working on together, and then, also, with individual efforts to ensure that people can benefit from comprehensive biomarker testing no matter where they live or where they are treated.You know, we're getting to that, so in the meantime though, I do think that patients should, at a minimum, ask their doctor for comprehensive biomarker testing.Ask if they've had it, and if not, not to be afraid to go get a second opinion or to go elsewhere for that, and to know that resources exist to help them, if their insurance doesn't pay, to get coverage for these tests, because it is essential in lung cancer to know your biomarker and to understand your disease before going on to a treatment.

MS. SHAW:Thanks for sharing that great advice for patients and how they can engage with their healthcare professionals when it comes to biomarker testing.Eric, we've heard the Association of Molecular Pathologists is working on a Precision Medicine Initiative.Can you tell us more about that?

DR. KONNICK:Yes.The Association for Molecular Pathology, or AMP, has many different projects in the works kind of under this umbrella.Currently, there's some educational initiatives that we're working on, some patient-facing products to help patients understand what goes on in the laboratory, how that testing is actually producing a result. We've been working with LUNGevity in terms of coming together on common terminologies that can be used in biomarker testing and reporting, to really bring some consistency there.We've also had some surveys of our membership and the wider laboratory community, looking at the effects of COVID for example on our ability to do testing and what the work that goes into that testing is, to really give us a better idea of where the weak points are, where we can advocate for changes in policy to help improve the quality of care and consistency of care.

Many different things going on all the time, but I mean, I think you can get from the Association's name, Molecular Pathology, that's what we do.We do that personalized medicine as part of everyone of our members' practice.

MS. SHAW:That sounds great.I-Fen, to wrap things up, what are the kinds of things that industry can do to make things easier for all of this?

MS. CHANG:That's a great question.I think it's important for us as an industry to continue to support the educational and awareness efforts that the advocacy community and the panelists that you've heard from, today, are spearheading.The barriers and some of the solutions that we've discussed today, is just the beginning of a joint journey.These efforts are especially important and some of these issues have been amplified now, as we start to learn a little bit more about the long-term consequences of the COVID pandemic.Just to give you an example, some of the statistics that we've seen have shown that about a third of adults have not received their recommended screenings for associated age risk.This coupled by the fact that almost half of the patients have missed their routine preventative appointments during COVID, can have a tremendous impact in terms of early diagnosis and potentially, even the outcomes of patients.

These issues that we've discussed today, are quite complex, and in order for us to find these sustainable solutions, we really believe that we need to take a multiprong and a multidisciplinary approach.We believe that the efforts that we've embarked on are unique, as they bring together various voices.It brings the voices of the patient advocacy groups, physicians, as well as industry partners, together, all with a common goal and as we've discussed, this is ultimately to raise awareness and potentially remove some of the barriers that are associated with biomarker testing.

Our ultimate hope is that no matter where the lung cancer patient lives, where they receive their care, and whatever their socioeconomical status may be, that comprehensive biomarker testing be widely available to them.

Questions and Answers

MS. SHAW:Thank you, I-Fen, and thank you to all of our panelists.Just a reminder to the audience, if the audience would like to submit a question, we encourage you to ask questions during the event.You can submit questions still, by typing them in the Q&A box.Our first question is for Robert.We had a lot of questions about family risk or genetics for lung cancer.Can you explain the difference between genetics and genomics in lung cancer?

DR. SMITH:There are simple family histories for which we cannot really attribute that risk to a specific mutation, that is associated with high penetrance, in other words, very, very high risk.But our risk models due show that family history matters, and as we get to the point where we can either test to identify those patients that have an absolute risk, that would approximate those that presently, we rely on from a history of tobacco use, there may be an opportunity to include these patients in guidelines and recommendations.I think this is a goal that all of us have, is some way to identify the many patients that we don't have a good risk profile right now, or at least one that's not associated with the randomized trials and the guidelines that we have for screening, to bring those patients in.

We do have this for breast and colorectal cancer, and we have guidelines that are very specific to bringing them in to screening, for example, many years younger than otherwise would be the case for people who don't have that family history.

MS. SHAW:Thanks, Robert.The next question we have is for Claire.Someone commented they did not see a KRAS link on the slide; is there one for the biomarker testing tool?

MS. SAXTON:Sure.The slide that you saw showed one part of the screen, which talked about those biomarkers that are associated with a currently approved targeted therapy drug that could be used if you test positive for them.If you keep scrolling down, you can see other biomarkers that are in clinical trials, including KRAS and several others.

MS. SHAW:Thanks for that clarification on the tool, Claire.Our next question is for Eric.Eric, if biomarker testing was conducted, for example, on pleural effusion and identified a biomarker but subsequently another effusion was identified, for example, pericardial, does the biomarker testing need to be redone to confirm the same gene mutation, or rule out there is not a different one?

DR. KONNICK:That's a really good question and one that, unfortunately, we see very frequently.If a patient has a biomarker that is actionable and they're on treatment for that, and then they have a relapse, which can be an effusion for example, it's certainly reasonable to retest and see if, number one, if the same original mutation was present, and then also, what we're increasingly looking for, are things called resistance mutations.Those resistance mutations will often direct the next line of therapy or direct patients to clinical trials.It really will depend on the clinical scenario.So again, if a patient was responding and now is not responding, or is suspected of not responding, retesting is absolutely reasonable.But if they're responding just as well, it may not be a reason for testing at that time.

MS. SHAW:Thanks, Eric, and I've got another one for you.Is there any biomarker for small cell lung cancer?

DR. KONNICK:Not as we think of in the comprehensive setting.We do see providers occasionally testing looking for potential targets, but we haven't seen things as consistently.The mutations that we think are core to small cell lung cancer don't have treatments at this time.

MS. SHAW:Thanks, Eric.Andrea, the next one's for you.Is molecular testing the same as comprehensive biomarker testing?

MS. FERRIS:Very good question, and this is why we had the consistent testing terminology working group.Going back to 2015, we did an audit, there were 23 different terms being used for the same thing.Molecular testing, and Eric or Bob, you might want to opine from a more scientific perspective than this, but comprehensive biomarker testing is the broadest umbrella term we could use for what we're trying to do.Comprehensive, meaning that it's not a singular test.We're not just testing for EGFR.We're not just testing for ALK.We're doing them all at the same time on what's called the multi-analyte panel or a comprehensive test.Sometimes it's next-gen sequencing, so I think that molecular testing is a type of comprehensive biomarker testing, but I think that really you want to ask for the full panel, rather than just the one-offs, because chances are pretty good the pathologist will run out of tissue before being able to test for all of the known biomarkers that are actionable, either with approved therapies or ones in clinical trial.But Eric or Bob, I don't know if you want to clarify on that.

MS. SHAW:Thank you.

DR. KONNICK:I can certainly comment on that.They're often used synonymously, in terms of molecular testing, comprehensive testing, but at the end of the day, we see a lot of corporations especially, have trademarks and things like that to refer to their tests.Those tests do have different things that they're looking for, and even at different institutions, they'll have a comprehensive panel that includes some things but not others.It is a shorthand to allow easier conversation without going through all the different things that were tested.But one of the things our oncologists do is when they have a new patient come into our system that's had testing on the outside, they send us the outside reports and say, "Tell me what we're missing from this." Again, it's that communication and our ability to say I'm looking at the pathology, I know this would be a challenge in this situation, here's what I recommend.Do we need to do a new biopsy, et cetera?Again, it is much more complicated than just a single test, and so just to recognize that complexity.

MS. FERRIS:Could I just add to that too, Sandra?I think that from a patient perspective, and again, I hope that patients don't need to ask for this, but if they do, at a minimum, make sure that you're being tested for all of the biomarkers that are in NCCN Guidelines, at an absolute minimum.That's something that all clinicians should be able to refer to.It's the National Comprehensive Cancer Networking guidelines, is what it stands for.They create the guidelines that ensures pay for and that clinicians often rely on, so I would say at a minimum, make sure that you're being tested for anything that's listed there, but in addition to other ones that are perhaps in clinical trial.

MS. SHAW:One additional thing, for pages for patients, is NCCN also has a patient version of their guidelines and you can download an app of the patient version.So, you can get a patient friendly version of guidelines for your type of lung cancer.Bob, did you have anything to add to that, before I move to the next question?

DR. SMITH:These answers are very comprehensive and everything I was about to say somebody came and said.But Andrea's point in particular, given the fact that turnaround times are slow, sequential testing just puts the patient in this long period of limbo.We have seen that clinicians who report that their setting has a policy about testing, tend to have higher rates of testing and more guideline adherent testing, but a policy could be out-of-date.So, to Andrea's point, the patient needs to be tested for every mutation that's associated with a treatment that is FDA-approved.There need to be additional ones because even if it isn't FDA-approved, it could be a focus of a clinical trial.The idea of testing for one biomarker at a time, is something that we've just got to put a stop to.

MS. SHAW:Thanks, Bob.The next question's for Eric.If a cancer has metastasized to the lungs, is the biomarker testing the same?

DR. KONNICK:It's a good question.It depends on the cancer type, so some cancers have biomarkers associated with them that have approved therapies or therapies in clinical trials, and unfortunately, we still have some types of cancer that don't.Most settings will recommend a comprehensive type test on metastatic disease to look for potential targets.There's actually a couple that are approved for all cancer types, which is great.Something called - - stability, tumor mutational burden, and then, NTRK mutations, or NTRK fusions for NRTK-1, -2, and -3, those can be tested in any cancer type because we've seen those in every cancer type.At a very minimum, regardless of it's a sarcoma, carcinoma, melanoma, those would be reasonable, and then, beyond that, it'll depend on the specific cancer.

MS. SHAW:Thanks, Eric, for covering all those mutations.I-Fen, if I found out I have a KRAS mutation, but I'm not enrolled in a trial, what can I do to gain access to the KRAS therapy?

MS. CHANG:That's a great question.I think the first thing is to really understand that there are different types of KRAS mutations, right?In the case of many of the studies that are currently available, it's specific to KRAS G12C which is a specific point mutation.For patients with that type of mutation, there are various clinical trials that are available.Clinicaltrials.gov is a good source to find out where these trials are, what types of designs are available for those patients that are not eligible for clinical trials, or don't meet the clinical trial eligibility.There are companies also, that are offering expanded access programs for patients before these products become commercially available.

MS. SHAW:Thanks, I-Fen.The next question is for Andrea.Andrea, is coverage currently considered a state option, or is it not addressed, and if it's not addressed, is there a strategy for working with CMS instead of state-by-state?

MS. FERRIS:That's a very complex question.I wish I had my policy person on the phone with me.But I think it's an answer of both.CMS for Medicare, they have a national coverage decision for FDA-approved next-gen sequencing, that's for Medicare.Medicaid is a state-by-state insurance program for underserved populations, so that is a state-by-state initiative that you need to work with the local offices for Medicaid reimbursement.Then, there are also commercial payors who are neither Medicare, nor Medicaid, and they make their own decisions, and we are working with them as well.And then, there are the employer-based health systems as well, and so you have to work with them separately.But I think it once it is adopted and the clinicians and the oncologists are demanding that comprehensive biomarker testing be done, because that is how you create your optimal outcomes and treatment paths, at some point in time, I don't think we're quite there yet, it will become standard practice and hopefully, be reimbursed.

Bob, I don't know if you have any more information from the ACS side.I know we're working with ACS CAN, your policy group on the state-level work, but I'm not sure if you have any other insights on that?

DR. SMITH:I really don't, but I'm glad that we're working in parallel on these issues, and they're the ones that I think are going to be able to pursue policy issues that actually could be effective.This is where a lot of efforts are coming together simultaneously, which is a good thing, and they're really pros at this kind of thing.Especially at the state level, they have people in every state that can pursue these policies if the state is ready to take them up.

MS. FERRIS:Yeah.We did a state-by-state report card as well, where we looked at each state to see whether they were covering screening, comprehensive biomarker testing and participation in clinical trials.We're dovetailing that with the work that you guys are doing to really target the areas that have high incidence of lung cancer and are not yet covering it, to ensure that happens.

MS. SHAW:Policy is always a complicated area, but thanks to you guys, I think you covered off on all those issues.Claire, is NGS the same as comprehensive biomarker testing?

MS. SAXTON:This might be better put to our pathologist, but my understanding is that NGS, next generation sequencing, is one method to do comprehensive biomarker testing, so that you're getting multiple mutations being looked at at the same time rather than that sequential one-at-a-time mutation by mutation kind of testing.

MS. SHAW:Eric, do you have anything you'd like to add?

DR. KONNICK:Yes, the next generation sequencing is one of our laboratory techniques, but it depends on how you're going to consider it comprehensive.For example, we don't test for proteins when we use next-gen sequencing, we're looking at DNA or RNA with that particular technique.Things that we would commonly test for, like PD-L1 antibodies, that isn't part of next-gen sequencing.The testing we do for HER2 in breast cancer, and other cancers, esophageal cancer, that's looking at proteins.That isn't part of next-gen sequencing.Again, it's one of those things where next-gen sequencing, or NGS, is a technique, and it's multiplex and it's very powerful, but it doesn't cover all the things we need to test for.

MS. SHAW:Thanks, Eric.Next question for Claire, if chemotherapy is suggested to be started, while I wait for the results for comprehensive biomarker testing, can that impact potential benefits of targeted therapy, once the biomarker results are received? - -.

MS. SAXTON:The medical professionals on the call are more than welcome to jump in on this as well, but from a patient perspective, we know that some of these targeted therapies are providing actual benefit knowing that you have a particular subtype.If you don't find out if you have that particular subtype of lung cancer, and you just treat it generically with chemo, you can end up with people having the side effects of chemo, without knowing that that chemo will actually be helping to treat the cancer.

MS. SHAW:Bob, Eric, do you guys have anything to add to that? - -?

DR. KONNICK:Yeah, there's certainly situations where you would, if you have a mutation that is targetable, you would want to start with therapy for that.The other thing to always consider is that while that's the ideal situation, sometimes there's other considerations that indicate to an oncologist that they need to act now, and so that may be chemotherapy, that may be radiation.We think of those things as medical emergencies sometimes, and so, I think, again, there's some nuance to it, but there may be other reasons that they're considering that particular treatment at a given time.Again, you're having that conversation with your oncologist and knowing about what the biomarker testing that's indicated, and discussing those options is absolutely critical and it's important for patients to have that conversation.

DR. SMITH:The only thing I would add to what Eric just said, was just comprehensive, is that you'd like to be able to make these decisions under the best circumstances, which means that you're not making them in the absence of having the information on your biomarker tests in time.In other words, it needs to be timely.Too often patients go on therapies that maybe won't be the best therapies for them because they're naturally impatient with how much time has elapsed.

MS. SHAW:Bob, kind of going along with that theme of giving the results to the patient, when biomarker tests are done, are there any guidelines about giving the patient the report?

DR. SMITH:These reports can actually be baffling, even for clinicians.The more complex ones can go on for pages and pages and pages, and some have complained that it's very difficult to even ascertain what information is immediately most pertinent to the patient.I think that the important thing is that whichever markers might be tailored to a particular therapy, that the patients get these, and get them in timely basis, so they can make an informed decision with their doctor.

MS. SHAW:Yeah.That's very important.Andrea, a follow up question.Is the state-by-state info about coverage of testing available online, do you know?

MS. FERRIS:Yes, it's on our website, which is www.LUNGevity.org, in our policy area, or you can go into the search and look for lung cancer score card.

MS. SHAW:Thank you for that, Andrea.With that, we're almost out of time.Are there any final thoughts from the panel that you'd like to share before we wrap up?Anyone?

DR. SMITH:Well, I'll just say that I hope that the next time we do this, and I hope we do do it a next time, that we will be able to show that there's been progress in our collective work to make prompt and effective biomarker testing as a standard of care in all settings.

MS. SHAW:Thanks, Bob.We all agree on that.Go ahead, Andrea.

MS. FERRIS:The only other thing that I was going to mention, and I think it's been brought up a few times, in some of the responses to the questions, is I think comprehensive biomarker testing is hugely important and it's essential, but I think it's equally, if not more important, that, if possible, which isn't always medically possible, but to wait for the outcomes and wait for the results before making treatment decisions with your clinician.It's not enough just to get tested, you need to use the results of the test in order to be put on to the right treatment for you.I think that's hugely important as well.

MS. SHAW:Yeah, and for all the patients online, don't hesitate to reach out to these great organizations when you need help, you need answers, and you need support.They're certainly there for you, day in and day out.Thank you all, for your participation, it's been a great session.If you’d like to watch this webinar again, it will be available on the Webinars-On-Demand page of Curetoday.com within the coming days. I want to thank our panelists and the audience for attending and participating today. I would also like to thank Amgen for making today’s educational webinar possible. Don’t forget to check your email tomorrow for the survey to be entered to win a gift card. Thanks to all for joining, we’ll see you next time. Good-bye.