Campaign aims to increase use of ‘crucial’ biomarker testing in NSCLC
National Comprehensive Cancer Network guidelines recommend all patients with advanced nonsquamous non-small cell lung cancer undergo biomarker testing.
Biomarker testing has the potential to identify mutations in specific genes — oncogenes that cause cancer cells to divide and grow — that can match patients with appropriate FDA-approved targeted therapies or immune checkpoint inhibitors.
Despite the recommendation, testing remains far from universal.
Data presented by Robert and colleagues at this year’s virtual ASCO Annual Meeting showed that only 46% of patients with advanced NSCLC underwent testing for five targetable biomarkers for which FDA-approved therapies existed between 2018 and 2020. Testing rates for individual biomarkers ranged from 59% for BRAF to 67% for ROS1, 70% for ALK, 71% for EGFR and 84% for PD-L1.
Bruno and colleagues presented data at ASCO that identified racial disparities in use of biomarker testing for patients with advanced NSCLC.
LUNGevity Foundation — a nonprofit organization that aims to improve outcomes for people with lung cancer — launched its No One Missed campaign this year to increase biomarker testing in NSCLC.
The goal is to ensure every patient undergoes testing, resulting in a fully informed diagnosis that can guide optimal treatment.
“Without biomarker testing, [patients with lung cancer] may miss the opportunity to receive therapies targeted to their type of lung cancer,” Christine M. Lovly, MD, PhD, associate professor of medicine in the division of hematology-oncology and Ingram associate professor of cancer research at Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, said in a press release. “With a rapidly expanding number of FDA-approved, biomarker-driven therapies for NSCLC and new scientific breakthroughs on the horizon for all lung cancers, the role of biomarker testing is critical. There has never been a more important time to bring this message to ... patients and providers.”
Healio spoke with Lovly about the campaign, the importance of biomarker testing in NSCLC, and the role oncologists and other members of the care team have in ensuring their patients undergo this testing.
Healio: Why is it so important that patients with nonsquamous NSCLC undergo guideline-recommended biomarker testing, and how important is an effort like No One Missed to achieve that goal?
Lovly: According to American Cancer Society, 235,760 Americans will be diagnosed with lung cancer this year. NSCLC will account for about 85% of those cases.
A significant number of patients with NSCLC will have tumors with genetic changes, also known as driver mutations. Presence of these driver mutations makes their lung cancer eligible to be treated with a targeted therapy, which is defined as a treatment that is matched to a specific biomarker within the tumor.
Coupled with imaging and tumor biopsy, evaluating for tumor biomarkers is a critical part of the diagnosis and treatment planning for patients with NSCLC. However, data suggest that not every patient with nonsquamous NSCLC has received tumor biomarker testing based on professional guidelines. We need to understand the barriers to obtaining tumor biomarker testing so that we, as a cancer community, can provide the best overall care to our patients. That is why this awareness campaign is so important. We are working to ensure there is “no one missed” when it comes to biomarker testing in NSCLC, because it is crucial to getting a fully informed diagnosis and appropriate treatment.
Healio: Did the low rates of biomarker testing identified in the study by Gierman and colleagues surprise you?
Lovly: We are all on a learning curve, and there are many barriers that physicians and health care workers may experience with respect to obtaining recommended tumor biomarker testing. New biomarkers along with drugs that match them are being added constantly to the lung cancer treatment regimen. It is often difficult to keep pace with this tremendous amount of progress. I am excited about the No One Missed campaign because we are trying to help the entire cancer community to deliver the most current, most precise treatment plan for all patients with lung cancer, and tumor biomarker testing is a critical part of this equation.
Healio: Why do so many patients with NSCLC not undergo guideline-recommended comprehensive biomarker testing, and what barriers must be overcome before testing becomes more widespread?
Lovly: There are many reasons why tumor biopsy samples from patients with lung cancer are not being tested. Potential barriers to biomarker testing include inadequate tumor material in the biopsy sample, operational challenges involved in tissue stewardship and handling/processing, variability in insurance coverage for testing, and increased costs for patients due to insufficient reimbursement payments for performing biomarker testing. Further, although the rapidly evolving number and type of biomarkers in lung cancer is a testament to research advances, it can be challenging for providers to stay current.
Healio: How does the lack of testing hinder informed decision-making and reduce chances for optimal treatment?
Lovly: If health care providers are not aware that a patient’s tumor is positive for a certain biomarker, they cannot prescribe the appropriate therapy that targets that biomarker. Biomarker testing results are crucial data. Without that information, an oncologist cannot make a fully informed diagnosis or treatment decision. Biomarker testing also helps us to prevent a patient from getting suboptimal treatment or sequence of therapies. For example, some patients with lung cancer whose tumors harbor a driver mutation who receive an immunotherapy before they receive a targeted therapy experience a higher incidence of severe immune-related adverse effects. This has been reported among patients with EGFR mutations who received osimertinib (Tagrisso, AstraZeneca) after an immune checkpoint inhibitor, and among patients with oncogenic alterations in ALK, ROS1 or MET who received crizotinib (Xalkori; Pfizer, EMD Serono) after an immune checkpoint inhibitor.
Healio: What would you say to oncologists and other members of the cancer care team to encourage them to play an active role in making sure patients undergo guideline-recommended biomarker testing?
Lovly: Biomarker testing results are a crucial piece of information needed to provide appropriate therapy when possible. Each year, more and more markers and therapies are being identified. These newly available therapies are one factor contributing to improved survival rates for patients with lung cancer. We all share the common desire to deliver the best treatment options for our patients. We also share the professional responsibility to ensure that we are able to provide our patients with the most informed treatment recommendations possible.
Healio: What can clinicians who already have embraced the concept of comprehensive biomarker testing for their patients do to support the No One Missed campaign?
Lovly: Talk with your patients and your colleagues in the medical community about what biomarker testing is and why it is important. Stay up to date with the latest research and findings on new treatment options for patients. Share resources from the No One Missed section of LUNGevity Foundation’s website with patients who need additional information on biomarker testing. We welcome, and encourage, any advocates for biomarker testing in their own medical communities.
Healio: No One Missed will introduce tools to empower patients and caregivers to request comprehensive biomarker testing. Will the campaign include components directed toward oncologists and other members of the cancer care team to increase awareness of this issue?
Lovly: During this first phase, we have been focused on engaging patients and their families and loved ones, so they feel informed and empowered to discuss biomarker testing with their health care team. We also believe it is critical to assist health care providers in communicating with their patients, and we plan to create point-of-care materials to facilitate these conversations. We will work closely with multiple oncology professional societies and organizations to glean their expertise on the best ways to educate providers on what biomarker testing is and why it is important.
Healio: Is there anything else you feel is important to emphasize?
Lovly: A pivotal paper published in The New England Journal of Medicine in 2020 showed a reduction in incidence of lung cancer and decreased mortality from NSCLC in particular. This improved outcome for patients with NSCLC was attributed, in part, to research leading to treatment advances, especially in the use of targeted therapies. Therefore, it is crucial that we obtain biomarker testing for our patients in order to deliver on the promise of precision medicine.
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