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This article is sponsored by Eli Lilly and Company.

In this special sponsored episode from Eli Lilly and Company, I am joined by Dr. Lee James, senior vice president, oncology medical affairs at Lilly, to discuss the importance of lung cancer screenings, early diagnosis, and advancements in biomarker testing.

Dr. James has an extensive academic background and patient experience in lung cancer, which drives his enthusiasm for his work, as he noted, “I have been passionate about this space for 20 years.”

Lung cancer is the second most common cancer in both men and women and is the leading cause of cancer deaths in the U.S., responsible for approximately one in five cancer deaths.

Of the types of lung cancer, non-small cell lung cancer (NSCLC) accounts for about 80 to 85 percent of all lung cancers and includes adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.

“Understanding that basically anybody with lungs could potentially get lung cancer is an important reset. We have a lot of work to do to educate people about the prevalence of lung cancer and how it really can be a disease that affects anyone,” Dr. James says.

Screening and early diagnosis

To best improve patient outcomes, lung cancer screening and early detection are critical. Finding and treating lung cancer early, before it has spread, markedly increases a person’s chance of survival. Screening is associated with a 20 percent reduction in the risk of mortality from lung cancer, and one death is prevented for every 320 people who are screened for lung cancer.

Unfortunately, screening adoption rates for eligible patients in the U.S. remain low (18 percent). Eligible patients include those who are ages 50 to 80 years, have a 20 pack-year smoking history or currently smoke cigarettes or quit within the past 15 years. Among those eligible, cited barriers to low-dose computed tomography (LDCT) screening adoption may include limited awareness, inconvenience, medical distrust, stigma, and perceived financial burden.

A LDCT scan is a quick, non-invasive imaging procedure that uses significantly less radiation than a standard CT scan. These images are then processed by a computer to create a detailed view of your lungs.

“We find that only about 18 percent of eligible patients are actually getting lung cancer screening, as opposed to well over 50 or 60 percent for other tumors,” Dr. James says.

Increasing utilization of LDCT screening for NSCLC starts with closing knowledge gaps around eligibility of LDCT screenings and increasing awareness of screening as a treatment option. But early detection is only the first step in improving patient outcomes in NSCLC. Regardless of the stage at diagnosis, comprehensive genomic profiling (CGP) is equally vital and equips patients and care teams with important information to inform treatment decisions.

“Step one is finding the cancer as early as possible. The next step is not stopping with the diagnosis until you know exactly what the molecular profile of that cancer is,” Dr. James says.

The importance of comprehensive genomic profiling

Cancer is a disease of the genome, and finding the appropriate treatment requires a full understanding of the genomic drivers of a person’s specific cancer, which can help provide information about selecting the most effective therapies while ruling out treatments that may be unlikely to help.

CGP is the most thorough type of biomarker testing that looks for alterations in the DNA of a patient’s tumor cells to better understand the genomic drivers of lung cancer and inform options for targeted treatments. This form of testing is used in the precision medicine approach, in which an individual’s unique cancer profile is considered in diagnosis and treatment.

“It is very important that if you really want to understand the full picture of somebody’s cancer, you understand the totality of it. That means comprehensive testing. It is one test, but it looks for many different things,” Dr. James says.

CGP in early-stage NSCLC allows for a better understanding of one’s cancer diagnosis and an opportunity to receive care that is tailored to an individual’s unique cancer profile earlier in the treatment journey. People with lung cancer who receive targeted therapy based on biomarker testing results have a higher five-year survival rate compared with those who receive non-targeted therapy.

“If you look at patients with a mutation discovered by comprehensive testing, get that diagnosis, and go on an appropriate treatment, their five-year survival could be over 80 percent,” Dr. James says.

Approximately 70 percent of people with NSCLC carry biomarkers that can inform treatment decisions, potentially opening doors to targeted therapies regardless of disease stage. This significant proportion underscores the critical role that pulmonologists, oncologists, and surgeons play in their patients’ care, specifically educating them about CGP and advocating for biomarker testing as a standard part of treatment planning. This science-driven approach offers patients more than just options; it offers perspective on potential treatment options.

“The message to patients is very clear: There is hope. A good part of that hope is based on the science being developed using their full genomic profile,” says Dr. James.

Lilly is committed to working with the lung cancer community to provide broader access to lung cancer screenings and genomic testing for patients.

Lee James is a hematology-oncology certified physician and senior vice president of global oncology medical affairs at Eli Lilly and Company.

VISIT SPONSOR → https://www.lilly.com/conditions/cancer/lung-cancer

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Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. Subscribe at KevinMD.com/podcast.

Today we have a special sponsored episode from Lilly. Dr. Lee James will join Lilly as senior vice president, oncology medical affairs, bringing extensive leadership experience from Bristol Myers Squibb and Pfizer across oncology development and medical affairs. He trained at Cornell, the University of Washington, Fred Hutch, the University of Chicago, and Memorial Sloan Kettering. Lee is also a former practicing oncologist serving high-needs communities in Queens, New York.

Today, we’ll be discussing “Why early detection matters: Transforming lung cancer care.” Find out more at lilly.com. That’s lilly.com. The link will be in the show notes. Lee, welcome to the show.

Lee James: Great. Thanks, Kevin. Thanks so much for having me. It’s great to be here and to have a chance to talk to your audience.

Kevin Pho: All right. So, let’s start by briefly sharing your background and your role at Lilly.

Lee James: Yeah, great. So, as you mentioned, I have an extensive academic background, but the short form of it is really that I’m a medical oncologist by training. I did that training at Sloan Kettering, but I didn’t just do general oncology. In addition to that, I really had a focus in lung cancer. So, I’ve been passionate about this space for 20 years.

After that academic training, I went into private practice in a community group in Queens. And then about 15 years ago, I joined pharma. So, as you said, I’ve been at some different companies. I have the privilege and honor here at Lilly to lead our medical affairs group for oncology. And so I lead a pretty large team of people who think about the safe and effective use of medicines and how we can educate doctors and patients.

Kevin Pho: And what makes you passionate specifically about lung cancer research and working in the lung cancer space?

Lee James: Yeah, I think there are two parts to that. One is that nerdy scientific interest. You know, we understand that cancer is a molecular disease, and over the years we’ve come to understand the real drivers of lung cancer. The brain part of me is just fascinated by our ability to take our understanding of biology, understand how it leads to disease, and then come up with treatments to treat that disease based on our understanding. That’s amazing.

But I’ve also had very personal stories with cancer, as many of us have. I have an aunt who was never married, had no kids, was a nonsmoker, and in her 70s developed lung cancer. And so I was then not on the, you know, white-coat side of the bed, but really sitting with her through the diagnosis journey, the treatment journey, and some difficult end-of-life conversations, and it’s very personal for me as well. I think we’ve come a long way, but it really highlighted for me how much there is yet to do.

Kevin Pho: Can you talk a little bit more about who can be affected by lung cancer and which groups are more at risk?

Lee James: Yeah, you know, I think there’s a lot of misunderstanding around lung cancer, so I’m happy for the opportunity to talk about that. Certainly we know that tobacco is a risk factor, and people can reduce their risk by not smoking. But 20 percent of patients with lung cancer are never smokers or have smoked fewer than 100 cigarettes in their life.

So understanding that basically anybody with lungs could potentially get lung cancer is an important reset, and for me personally, with my aunt, that was firsthand experience of that. So we have a lot of work to do to educate people about the prevalence of lung cancer, but also about how it really can be a disease that affects anyone.

Kevin Pho: You’ve emphasized the importance of early detection and access to screening several times. Once someone is diagnosed with non-small cell lung cancer, are there specific tests beyond imaging that can help guide treatment decisions?

Lee James: Yeah, absolutely. So, when we think about a diagnosis, we want to know: What is it? What is this cancer? And where is it? How far has it spread from where it started? Those two pieces of information really help us understand what’s likely to happen for that patient with that cancer. When we talk about early detection of lung cancer, that’s really finding it before it has spread throughout the body.

But when we say what it is, that word “lung cancer” is really not enough. It’s the beginning of a diagnosis, but it’s not the full story. So when we say lung cancer, the next step is really the genetic information about the mutations that might be associated with that lung cancer. When I was in training, there were two or three. Now there are upwards of 20. And it is amazing how many different kinds of lung cancer there are.

The molecular mutations become so important because if they are present, they really guide treatment. And so step one is finding the cancer as early as possible, and the next step is really not stopping with the diagnosis until you know exactly what the molecular profile of that cancer is.

Kevin Pho: Now, before talking about the molecular profile, as you know, I’m a primary care physician. Just tell me what kind of options I have to screen for lung cancer, and when should I be thinking about it when I have a patient in front of me in the exam room?

Lee James: Yeah. So the screening recommendations from the USPSTF, the United States Preventive Services Task Force, cover people who are between 50 and 80 and have a substantial smoking history. And maybe I’ll take a moment and talk about what we mean by substantial smoking history. The guidelines talk about 20 pack-years, but maybe your audience might not know what that means. When we say 20 pack-years, that could be somebody who smoked one pack a day for 20 years, two packs a day for 10 years, or four packs a day for five years. That’s how we get to that pack-year exposure.

So the screening recommendations are not going to cover everybody who might get lung cancer, but they certainly do focus on that higher-risk population. So if you’re in your office and you’re talking to a patient, you may say, “Do you smoke?” And they might say no. But that’s not the end of the conversation. You really want to understand their smoking history to see if they meet the risk criteria to go for lung cancer screening.

It’s important to understand that the screening is a low-dose CT scan, and usually people are followed closely. So if there’s a nodule or something that’s found, it doesn’t necessarily mean it is cancer, but everything that’s found should probably be followed up. People who are in a lower-risk category, if they’re younger than 50, might not qualify, but this is really where the conversation between the physician and the patient is so important.

And I know as a primary care doctor, you’re also thinking about colon cancer screening and breast cancer screening. Amazingly, for lung cancer screening, the rates are much lower. We find there are probably only about 13 percent of eligible patients who are actually getting lung cancer screening, as opposed to well over 50 or 60 percent for other tumors. So it’s an important part of the primary care conversation to really go through somebody’s history and understand what the right kind of treatment is for them.

Kevin Pho: You’re listening to a special sponsored episode from Lilly. We’re discussing “Why early detection matters: Transforming lung cancer care.” Find out more at lilly.com. That’s lilly.com. The link will be in the show notes. Lee, how has the use of comprehensive genomic profiling changed treatment options?

Lee James: Yeah. So, it’s a complicated word, so we’ll break it down, starting with “comprehensive.” What does that mean? In the past, when we only had two or three mutations to look for, you might order just two or three tests. So if there was, for example, EGFR, you might order just an EGFR test, and that might be enough. But as I said, now we have such a deep understanding of how many different kinds of mutations there could be.

There are tests that can be done on the tumor itself or on blood that are comprehensive. They look throughout the genome. They look throughout all of the expressed genes and find any abnormalities that are there. So you can find things that maybe you had top of mind, but there are other rarer things that might be discovered through comprehensive genomic testing. So, as I said, it’s very important: If you really want to understand the full picture of somebody’s cancer, it’s important to understand the totality of it, and that means comprehensive testing. It’s one test, but it looks for many, many things.

Kevin Pho: Despite the progress we’ve discussed with early detection and precision medicine, what challenges do physicians still face in getting patients diagnosed and treated?

Lee James: Yeah. So, I think if we think about the lived experience of a patient, right, the patient journey, it starts off with somebody who might have no symptoms or might have symptoms that lead them to a diagnosis. Getting a timely diagnosis is important because the earlier you find a cancer, the better the outcomes are. We talk about early-stage disease as catching something so early that surgery, or surgery and some other treatment options, might be enough for that cancer to go away and not come back. And when we think about a cancer going away and not coming back, that begins to feel like, you know, a potential cure for that patient, because they had something and they don’t have it anymore.

Once the cancer has spread, cure may not be an option, but the goal is to really maximize the amount of time that they have and the quality of that time. And this is where genomic testing is so important. If you look at patients with a mutation, and they have comprehensive testing, and they get that diagnosis, and they go on an appropriate treatment, their five-year survival could be over 80 percent. For those same patients without that information, their five-year survival is less than 10 percent. So I think that’s really an important take-home: It’s not just that this is guiding treatment, but it’s guiding treatment in a way that potentially has a huge impact for patients.

So, like I said, early detection is important and the diagnosis is important, but I think for all patients, it’s really about understanding their disease. Some people have stigma about lung cancer, but in a way, nobody should. Cancers happen to everybody, and it’s important to really just treat it as a disease, to understand and acknowledge that there might be some emotion that goes around that, but not to let that get in the way of making the best treatment choices.

Kevin Pho: Can you tell us about some of the challenges we still face regarding genomic testing, and how can clinicians work to address these challenges?

Lee James: Yeah. So most times, the person who might be ordering that genetic testing is not necessarily the oncologist. In your practice, I’m sure you have a pulmonologist that you work with. That pulmonologist might be the one who’s obtaining a tissue sample to send for testing. So when we talk about education, it’s certainly primary care doctors, but also the doctors who are obtaining tissue, because they’re going to be ordering the testing in a timely way, either on the blood or on the tissue that they get, in order to get the right diagnosis. So that’s one challenge: having the people obtaining the tissue know what they need to do with it.

I think another key part of the challenge is that our health care system is complex. It’s fragmented, and it’s easy for people to fall through the cracks. If you’re sending them to one doctor to get the tissue, and another doctor for radiology, and another doctor to talk about the results, there’s a chance that not all the information flows through or that patients are lost in the system. And so I think there is a lot of work to be done in making sure that things happen in a timely way.

I think the other real challenge is just educating people. Some people hear that word “lung cancer,” and they think that’s the end and they shouldn’t even do anything about it. So I also think this is about educating physicians and patients about all the progress that’s been made in this disease. When we look at the numbers, when I was in training, the five-year survival rate for lung cancer in general was around 2 percent. And recent data, you know, the 2026 numbers on the prevalence of cancer and survival, show us that that has increased dramatically. And so we have to really change our mindset from an outdated way of thinking, that there’s no hope, to really understanding the current landscape and that there are a lot of effective treatments.

Kevin Pho: So help me clarify where in the diagnostic pathway genomic testing would play. Would it be after you get a tissue diagnosis? And how can clinicians best communicate the value of comprehensive genomic profiling to newly diagnosed patients?

Lee James: Yeah. So the sooner it happens, the better, right? If that pulmonologist or that radiologist is getting tissue, that’s the best time to order it, right? Or if a really well-informed primary care doctor says, “Oh, this is the diagnosis. I don’t see all the information,” you know, really following up while that tissue is still available and sending it for testing.

But the next step would be that even if that patient doesn’t have the testing up front, they can go to their medical oncologist, who can access the tissue that has already been taken and send it for testing. Now, that requires sufficient tissue. So this is also where education is important. If a pulmonologist goes in and just gets a little bit of tissue, enough, they think, to establish lung cancer or not, that might not be enough to do the comprehensive genomic testing. And so it’s incumbent on anybody who’s getting the tissue to get enough so that all the appropriate testing can be done.

Kevin Pho: Can you share maybe an anonymized case study where genomic testing really changed the treatment course of a patient? I know I’m putting you on the spot here, but is there a case study you could share with us to really illustrate some of these tenets in action?

Lee James: Yeah, sure. So, I’ll tell a story about a patient that I have known now for many years. You know, the story has a nice outcome. This person was a medical student and passed out on rounds. They were found to have a huge amount of fluid around their heart and ended up in the ICU. They took some of that fluid and saw that the student had lung cancer. They took that fluid, sent it for testing, and found a brand-new mutation for which there was an available treatment.

Within days of getting that treatment, the patient started to feel better, and they were able to walk out of the hospital two weeks after being in the ICU. That person then decided not to pursue medicine but a PhD, and still on treatment, was able to complete their PhD work and is now married and has kids. And so it is an amazing story about the value of understanding. Even in a young medical student who had never smoked, but with a cancer that’s driven by a mutation, when you know the right information, you can have a really substantial impact.

I think the part of that story that really resonates with me also is all the other people in someone’s life who are impacted by a cancer diagnosis, and how, when you can have the right treatment, you’re also extending the sphere of impact of a beneficial treatment because of the quality of life and the amount of time that somebody has available.

Kevin Pho: You’re listening to a special sponsored episode from Lilly. We’re discussing “Why early detection matters: Transforming lung cancer care.” Find out more at lilly.com. That’s lilly.com. The link will be in the show notes. Lee, how would you describe the role Lilly plays in the lung cancer treatment space and its commitment to patients?

Lee James: Yeah. So, Lilly has been in the lung cancer space for a long time. Even when I was in fellowship and practice, I was very excited about the lung cancer medicines that Lilly had. And that long-standing commitment to the disease and the space and the patients has really borne out, because today Lilly has very exciting treatments that are being developed. Many of them are molecularly targeted treatments, which can impact patients with a particular mutation, while some of the treatments we have in our pipeline could impact people with a broader profile and not necessarily one particular mutation.

So I think the commitment of Lilly goes beyond just one disease or one narrow part, right? It’s really a commitment to patient education, working with advocacy partners, and working with established societies to really make sure that the information is out there and available. Make sure doctors and patients are talking. Really, hopefully, lifting the tide for all boats, so that there are more patients who are getting treated appropriately, who are being screened appropriately, and who are being tested appropriately. So I’m very excited and very proud to work for a company that has such a long-standing commitment and has so many different approaches to helping patients.

Kevin Pho: And what message would you like to give to patients with non-small cell lung cancer? And what message would you like to give to clinicians?

Lee James: Yeah. So the message to patients is very clear: There is hope, and a good part of that hope is based on the science that we have developed, and their diagnosis is not complete until they know their full genomic profile. That’s the message to patients: There is hope, and you need all the information.

I think the message to clinicians is similar in a way, right? There is hope. There’s not a reason to have a narrow, dark view of the prognosis, and the diagnosis is not complete until you have comprehensive testing. And importantly for physicians, screening, because the earlier you find a tumor, the better the outcomes can be.

Kevin Pho: And before we end, Lee, any last thoughts or take-home messages you want to share with the KevinMD audience?

Lee James: Yeah, I just think we are at such an exciting time in oncology in general, and in lung cancer in particular. Always be on the lookout for the latest treatment advances. I do want to put in a plug for clinical trials, because many of the most exciting or innovative therapies are actually available through a clinical trial. And so in addition to thinking about standard of care, all of the guidelines talk about consideration of a clinical trial.

There’s a great need to understand how patients might benefit from a new treatment, and the only way to do that is enrollment. So in addition to all the great work that your audience is doing in standard of care, I also always want them to be thinking about clinical trials as another option for patients.

Kevin Pho: You’ve listened to a special sponsored episode from Lilly, discussing “Why early detection matters: Transforming lung cancer care.” Find out more at lilly.com. That’s lilly.com. The link will be in the show notes. Lee, thank you so much for sharing your perspective and insight. Thanks for coming on the show.

Lee James: Great, Kevin. Thank you so much. It’s really a pleasure to be here.