The evidence is increasingly clear: comprehensive biomarker testing can improve patient outcomes and may reduce overall cost of care.
So why is knowing a patient’s biomarker so important to better care?
The advances in lung cancer treatment over the past decade, particularly in precision oncology, has made it essential to get a comprehensive picture of every patient’s tumor to help guide treatment decisions. This is because approximately half of all patients with advanced non-small cell lung cancer (NSCLC) harbor a driver mutation.1 Comprehensive biomarker testing at diagnosis, coupled with imaging and other clinical data is therefore critical to provide a fully informed diagnosis that can help both doctors and patients develop a personalized treatment plan to help improve outcomes.2,3
Today, biomarker testing can be performed either as a single gene test or as a comprehensive gene panel by next generation sequencing (NGS). As of June 2021, there are nine biomarkers currently actionable in NSCLC (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, EGFR exon 20 insertion, KRAS G12C).4 The newest actionable biomarker, KRAS G12C, until recently had no targeted therapy approved for patients. Treatment developments for this driver mutation are important as approximately 13 percent of all patients with non-squamous NSCLC have the KRAS G12C mutation and treatment options are limited for patients whose first-line treatment has failed or has stopped working.5
However, patients won’t know if they may benefit from a targeted therapy without receiving biomarker testing. Therefore, the expanding list of actionable biomarkers in NSCLC makes NGS an efficient and effective way to test all the relevant biomarkers at one time using a tissue sample or from the blood (liquid biopsy) when tissue is not available.
Despite clinical practice guidelines and recommendations from professional medical organizations to conduct comprehensive biomarker testing at diagnosis, broad panel testing remains inadequate in patients with advanced NSCLC. Case in point: in a real-world study conducted by the MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Network) Consortium™ focused on U.S. Oncology Network community practices across the country, less than 50% of the >3400 patients with NSCLC evaluated received comprehensive biomarker testing.6 However, rates are improving because there is growing consensus from many stakeholders about the importance of biomarker testing.7
The benefits of comprehensive biomarker testing are clear:
- Improved patient outcomes: The use of targeted therapy, enabled by biomarker testing, has been associated with a more favorable outcome in advanced NSCLC, with a 31 percent reduction in risk of death and improved survival duration that was about 1.5-fold longer compared to patients with an identified mutational driver but did not receive targeted therapy.2
- Healthcare cost savings: CVS Health presented a poster at the American Society of Clinical Oncology (ASCO) annual meeting, one of the world’s largest medical meetings, on costs associated with comprehensive versus narrow panel testing (or single gene testing) and found that broad panel testing significantly reduces the overall total cost of lung cancer care.8 One of the key observations from the poster was that "identifying the broader genomic landscape of a patient’s tumor earlier will empower oncology providers and lung cancer patients with information to make timely, precise treatment decisions that are ultimately more cost-effective and deliver better quality care."
As more targeted therapies aimed at driver mutations in NSCLC are approved, patients, providers and insurers will reap the benefits of comprehensive biomarker testing, but more must be done by all stakeholders to improve testing rates.
What can health system leaders do? Here are four questions to consider when evaluating health system readiness for biomarker testing:
- Is there an interdisciplinary precision medicine team responsible for biomarker testing?
- Have major NSCLC testing guidelines been reviewed and incorporated reflex testing systemwide, which calls for performing testing for currently known lung cancer drivers at the same time as diagnostic testing?
- Can healthcare practitioners (HCP) order biomarker testing from the Electronic Medical Record (EMR) software?
- Can HCPs easily search for patient biomarker results in the EMR?
What is Amgen doing to help increase the rate of biomarker testing for patients with advanced NSCLC to improve patient outcomes?
Amgen recognizes that there are barriers to comprehensive biomarker testing, but we are committed to working with the cancer community to help address these barriers. We are working with several patient advocacy organizations such as the LUNGevity Foundation, the Cancer Support Community, and the American Cancer Society to help empower patients on their treatment journey through education and development of tools on biomarker testing. One particular program that Amgen is supporting is No One Missed, a campaign driven by LUNGevity to build public awareness of comprehensive biomarker testing as a critical part of every NSCLC diagnosis and empower patients to discuss comprehensive biomarker testing with their healthcare team. This program has a particular emphasis on reaching underserved communities where testing rates are even lower.
In addition, Amgen is working with professional societies and healthcare provider organizations, particularly in the community setting, such as Association of Community Cancer Centers, Community Oncology Alliance, Association for Molecular Pathology, US Oncology and ION networks, on programs that address gaps in comprehensive biomarker testing and on identifying best practices and solutions to testing barriers.
Another way Amgen is working to address potential barriers to testing is through our Biomarker Assist™ program, which helps more patients with advanced NSCLC gain access to biomarker testing. Through the program, eligible patients may be able to save on out-of-pocket costs of biomarker testing. For full terms and conditions, visit www.BiomarkerAssist.com or contact 1-888-4ASSIST to learn more.
