Kristie L. Kahl

With the ever-growing treatment landscape in lung cancer care, biomarker testing’s role has become crucial in a patient’s journey. However, there is still a need to accelerate education around biomarker testing while granting access for all patients who receive a non-small cell lung cancer (NSCLC) diagnosis.

For example,Juanita Segura – who is a patient with NSCLC who shared her story in a video during the webinar – underwent biomarker testing which ultimately changed her treatment plan. “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,” she explained, adding that, while waiting seven weeks for her pathology report, she started treatment with traditional chemotherapy and radiation.

Juanita was originally treated at a community cancer center; however, she proactively changed centers to pursue biomarker testing. Luckily, for her, she did, because she found out she did in fact have an actionable mutation.

“And then the last day of my treatments, is when I was told I was ALK-positive … 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,” she said. “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.”

Juanita is still on tarted therapy today, seven years later, as a result of her biomarker testing.

Currently, there are multiple drugs approved by the Food and Drug Administration (FDA) or in trials to evaluate treatment for genomic alterations like ALK, EGFR, ROS1, BRAF V600E, NRTK, MET, KRAS and RET, ultimately improving the prognosis for patients with lung cancer, I-Fen Chang said.

“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,” said Chang, vice president and therapeutic head for Oncology Global Medical at Amgen Oncology.

However, she added, there remains an opportunity to improve education, awareness and access to biomarker testing. “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.”

Because of the gap that remains in awareness of biomarker testing – for both patients and providers – Cancer Support Community recently launched an online 

 to help patients with lung cancer and their caregivers understand what biomarkers matter for them and why. The goal of the tool is to empower patients to also advocate for themselves when it comes to biomarker testing. “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,” explained Claire Saxton, vice president of Cancer Support Community.

Moreover, the tool provides help at each question (in case a patient or their loved one is unsure of the answer) and also prompts for individuals to learn more. Once all question are answered, individuals receive a customized list of any biomarkers for patients to talk to their cancer care team about. Moreover, if a patient has not yet received testing, the tool offers tips for talking to health care teams about getting comprehensive biomarker testing.

If a patient has their biomarker testing results, they can click to learn more about their particular biomarker, what those results may mean and what treatments may be best for that specific subtype of lung cancer.

With an estimated 80% of patients receiving care in the community setting, versus academic institutions, there may also be an unmet need in ensuring patients are getting biomarker testing. In conjunction with the Association of Community Cancer Centers, LUNGevity is conducting a three-year study to understand the unmet needs from the patient side as well as the challenge from the provider’s side, with a particular focus on underserved communities and ethnic subgroups.

“In an ideal world, this should never sit on a patient's shoulders,” Andrea E. Ferris, president and chief executive officer at LUNGevity, said. “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.”

Similarly, the American Cancer Society supports a national lung cancer round table, comprised of 150 organizations, with a high priority focused on biomarker testing challenges in practice.

“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,” explained Robert A. Smith, senior vice president and cancer screening principal investigator of the National Lung Cancer Roundtable at the American Cancer Society.

While the changing landscape of lung cancer can contribute to challenges in coordination of care, the knowledge of biomarker testing puts the power back in the patients’ hands. Therefore, the Association for Molecular Pathology is working on various educational initiatives – including patient-friendly reports for NSCLC biomarker testing.

“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,” said Dr. Eric Konnick, from the University of Washington and the Association of Molecular Pathology.

“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.”

While challenges and barriers currently exist, one thing is clear: The cancer community is coming together as a whole to educate patients about biomarker testing to ensure they are receiving the right treatment in their cancer care.

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The combination use of Lenvima (lenvatinib) plus Keytruda (pembrolizumab) was added as a Category 1 recommendation by the National Comprehensive Cancer Network (NCCN) for the treatment of front-line renal cell carcinoma (RCC).

While these recommendations are intended for oncologists to manage cancer care, it is key for patients to also understand why this regimen is preferred and, moreover, how it can impact their treatment journey.

To help patients better understand the NCCN’s recommendation, and to assist in their conversations with their oncologists, CURE spoke with Eric Jonasch, MD, professor in the Department of Genitourinary Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas, and vice-chair of the NCCN Guidelines Panel for Kidney Cancer.

: Before we get into the new recommendation, can you explain to our patients what the NCCN recommendations are and why they’re important?

 The NCCN guidelines, our national coalition of centers of excellence, are organized by cancer type. We have a panel of specialists, including medical, surgical and radiation oncologists that populate these panels. There's a chair and vice chair for each of these panels. The goal really is to assess the different therapies that are available for a particular cancer, and to then make recommendations about the whether these should be used, what the level of evidence is and the level of enthusiasm for these particular therapies.

For example, if you have a clinical trial that is well designed … which usually means it's a randomized study, meaning that it's a study where you have two groups of individuals, one group who receives the standard of care and the other group will receive some sort of experimental therapy. If that trial is well designed and the results show there's a clear benefit for the experimental therapy, then (that drug will) end up getting a level 1 recommendation. And then there's also the preferred status, where the panel can state their preference for specific regimens.

So, this is just a way of allowing physicians to understand where, based on these expert recommendations, these particular treatments lie in the in the treatment armamentarium.

: Why is it significant that the addition of Lenvima plus Keytruda is now recommended as a preferred regimen for patients with first-line RCC?

 That's significant because it shows that, across the various therapies or combinations that are available for renal cell carcinoma, this particular regimen would be one of the first ones we would consider using in a particular disease state. This therapy was tested in the front-line setting, meaning individuals have not received prior therapy for advanced kidney cancer. And it is one of the preferred regimens because the strength of the evidence is such that we would want to see this being prioritized.

 So this study looked at over 1,000 individuals who had advanced renal cell carcinoma. It was actually three arms: The standard-of-care arm was Sutent (sunitinib); there was an arm with Lenvima plus Keytruda; and there was an arm with Lenvima plus Afinitor (everolimus).

The primary end point of this study was to look at progression-free survival, or the time it took for patients who are on this study to start having their disease grow again. And then there were a number of secondary end points, which are response to therapy, or how much shrinkage there is/ of the tumors, and also overall survival. This trial basically showed various, very strong results in all of these domains.

The progression-free survival was almost two years (23.9 months), compared to nine months for the standard-of-care arm. The overall survival – where we sort of look at the probability of death at a certain point in time or a median point in time – was clearly in favor of this regimen. And also, the response rate, meaning the percentage of individuals who had shrinkage, was almost doubled with this combination. And so, these are very strong data. And actually, even more impressively, the percentage of individuals who had complete shrinkage of their disease was 16%.

All of these various factors, together, show that this is one of the strongest regimens that's been tested so far in this particular setting, in advanced kidney cancer. And so the NCCN panel felt that these data deserve preferred status.

: What does it mean that this is a category 1 recommendation?

 A category 1 designation is driven by concordance amongst NCCN panelist and by the strength of the evidence. First, there is concordance amongst the panel that this regimen is efficacious. Second is that the quality of the data are very high. For example, this trial is randomized, there's a sufficiently large number of individuals in the trial that show that it's a robust study, and there are other studies that have supported these results, to show that it is not just a chance occurrence that this trial was positive. So these are the various things that make an NCCN level 1 designation.

: Is there anything in particular patients should know about this recommendation?

 Just that the preferred regimens should be prioritized in the consideration of treatment. Having said that, a skilled oncologist who makes these decisions can prioritize those therapies, even within the preferred category. Or there might be some circumstances that will make a preferred regimen not appropriate for a particular patient.

So, this is obviously a conversation that needs to occur between the patient and the physician. The physician can then explain what the different regimens are in these various categories, explain why one would be chosen over the other and whether there may be other choices that are not preferred, but that might actually be ideal for that particular patient for various reasons.

: What do you think patients with front-line renal cell carcinoma have to look forward to now that we have another preferred option in the regime?

 We are seeing that overall survival has increased consistently over the past five years, as more and more of these combination regimens have been approved. So, the chance of having a prolongation of survival has become a reality for many patients. The chance of a complete disappearance of disease is no longer a fantasy, but a reality. There is a small percentage of individuals who are cured in 2021, which is amazing. I would have been afraid to say that five years ago.

But, having said that, we are dealing with regimens that carry a real burden of toxicity, and can have an impact on quality of life. So, maintaining that dialogue between the treating team, the patient and the patient’s family to make sure that we can maximize quality of life while we're improving quantity of life is critical.

CURE spoke with Dr. Eric Jonasch about the National Comprehensive Cancer Network’s Category 1 recommendation for the combination use of Lenvima plus Keytruda for the treatment of front-line renal cell carcinoma. In particular, how it can impact a patient’s treatment journey.

Kristie L. Kahl

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NCCN Recommends Lenvima Plus Keytruda for First-Line Renal Cell Carcinoma: What Patients Should Know

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