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Advances in precision medicine continue to enhance the lung cancer treatment landscape, which is great news for patients and doctors. New therapies that target specific proteins linked to genetic mutations have the potential to improve outcomes for some patients. Roughly half of all patients with non-small cell lung cancer (NSCLC) harbor an actionable driver mutation, and further data show that targeted therapeutic approaches enabled by biomarker testing can lead to improved survival.1 This makes lung cancer a leading example of why comprehensive biomarker testing and re-evaluating patient data when new medicines become available are crucial steps at all stages of the treatment decision-making process.

The medical community understands the value of biomarker testing, illustrated by improved testing rates. Still, gaps remain, driven by several factors — cost, racial disparities in healthcare, or hospital operational issues.2,3 Additionally, biomarker information often doesn’t follow a patient through their treatment journey.

“There are many reasons for the gap in biomarker testing and why the data often does not find its way to doctors during the later stages of treatment, and we must collaborate across disciplines to understand and address the hurdles,” said Dr. Giuseppe Giaccone, vice president of Global Development, Thoracic Oncology at Amgen. “Investigation into identifying new biomarkers will grow the number of actionable targets. As more therapies arrive against known and emerging biomarkers in lung and other cancers, there is the potential to bring precision medicine to more patients — but only if we invest the same effort into advancing biomarker testing at all stages of treatment and making sure that doctors have access to up-to-date information when needed.”

There are opportunities to overcome these disparities and broaden the use of biomarker testing to realize the full potential of precision medicine at all stages of a patient’s treatment journey.

Comprehensive vs. single-gene testing

Biomarker testing is becoming more comprehensive. Broad panel next-generation sequencing (NGS) tests, which search for all known actionable and emerging mutations in one test, are recommended in many clinical guidelines over single-gene tests.4,5 Patients should be informed of the results and share the information if seeking second opinions. However, high upfront costs, reimbursement, and long turnaround times for results can deter some practicing oncologists from using NGS tests.6,7 Nevertheless, research suggests that NGS testing can lower healthcare costs and deliver clinical benefits for patients.8,9 Financial support may be available for patients, and Amgen partners with third-party organizations, such as the Association of Community Cancer Centers, to help practices better navigate testing.

Test, reassess, and retest

Biomarker testing at diagnosis can provide information vital to informing the first lines of treatment. But it isn’t a one-and-done situation. Later biomarker evaluation may uncover changes in a tumor’s genomic profile vital to second- and third-line treatment regimens. Ongoing testing may also determine if patients are eligible for new clinical trials or new therapies targeting biomarkers that become actionable after initial diagnosis.

That’s why it’s vital for biomarker testing results to be filed away. They may be particularly helpful, for example, if there’s progression to later stages of cancer or a change in doctor.10,11 Since 2019, actionable biomarkers for NSCLC have doubled in number.12,13,14 This includes the KRAS G12C mutation found in about 13% of patients with NSCLC.15 Meanwhile, DLL3 — a protein typically expressed at very low levels within normal tissues, but expressed on the cell surface at high levels in more than 80% of SCLC tumors — is being explored as a potential target for new therapies, known as T-cell engagers, that are designed to harness the immune system to help attack cancer cells.16

Innovation in liquid biopsies

Biomarker testing begins with a biopsy. A tissue biopsy to analyze tumor cells is considered the gold standard, though liquid biopsies that analyze cell-free DNA (cfDNA) shed from tumors cells into the patient’s bloodstream provide an option when there isn’t enough tissue to test, or a tumor is difficult to biopsy. Because liquid biopsies are performed on peripheral blood that’s easy to access, they can lower turnaround time for results and hasten time to treatment.17

All patients with advanced NSCLC should receive comprehensive biomarker testing

Smokers are less likely to receive biomarker testing compared to never or former smokers, which could negatively impact treatment.18 The two most common driver mutations associated with NSCLC are EGFR and KRAS G12C.19,20 About 40% of patients with EGFR-mutated NSCLC and roughly 93% of patients with KRAS G12C-mutated NSCLC have a smoking history.21,22 All patients with advanced NSCLC should undergo comprehensive biomarker testing since driver mutations can occur regardless of patient age or smoking status.

Other factors contribute to the testing gap, including where a patient is diagnosed and race. Data shows less than half of community oncology practices use biomarker testing to guide patient discussions versus 73% of academic clinicians.23 Further research shows Black patients with non-squamous NSCLC are 20% less likely to receive NGS comprehensive biomarker testing compared to white patients.24

Expanding access to biomarker testing requires a multiprong approach

More can be done to improve biomarker testing, including raising awareness among patients and doctors at community hospitals, supporting oncology practices in implementing biomarker testing and addressing disparities in care.

Amgen supports initiatives that promote biomarker testing awareness and access with several organizations, such as Community Oncology Alliance, LUNGevity, Cancer Support Community and the European Society of Pathology.

 To learn more about how Amgen is working to expand access to biomarker testing and improve access to precision medicine, visit


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