PD Dr. med. Matthias Scheffler is an oncologist working in the Lung Cancer Group Cologne (LCGC) at the University Hospital of Cologne and is also an investigator at Network Genomic Medicine (NGM). He studied medicine at Cologne University, where he also went on to complete his doctoral thesis. He leads the molecular tumor board of the Center for Integrated Oncology (CIO) Aachen Bonn Köln Düsseldorf.

What is biomarker testing and why is biomarker testing important?

Biomarker testing is a group of laboratory-based tests that look for naturally occurring molecules of health, in samples of a patient’s blood, bodily fluids and tissues.³ The test results are given to clinicians so they can plan the best care for their patients. In lung cancer, biomarkers are often driver mutations which are genetic alterations that cause cells to grow out of control. Common driver mutations in lung cancer are: KRAS, EGFR, BRAF, ALK, MET, ROS-1, NTRK.⁴

I believe all patients newly diagnosed with lung cancer should undergo biomarker testing. For me, as a clinician, it is important to identify the most appropriate treatment for each of my patients; knowing their biomarker status is paramount to me making this decision.

How does biomarker testing help clinicians to decide the most appropriate treatment option for each patient?

Biomarker testing may help clinicians and patients to better understand the characteristics of their lung cancer, as well as potentially personalize a treatment plan to help the patient fight the cancer more effectively.³ Choices around selecting the most appropriate lung cancer treatment depends on the patient’s lung cancer type and stage as well as their general health.⁵ In the case of non-small cell lung cancer (NSCLC) for example, about 40% of patients are diagnosed when they are in stage IV.⁶ In this patient group, radiotherapy is not recommended and limited benefits (e.g. reduced response rates, shorter response times, poor overall survival) are seen with chemotherapy regimens, which have remained unchanged for many years, especially in lung cancer patients that have relapsed or whose cancer has spread.⁷ Therefore, we need to continue to research and develop other systemic treatment options for patients with advanced cancer. Targeted therapies aimed at particular mutations, as well as several immuno-oncology therapies targeting specific proteins, are showing great promise in helping to address the current unmet need in lung cancer.⁴

What does the future of biomarker testing look like?

As more and more biomarkers emerge, laboratories should think about switching to testing methods which can evaluate multiple biomarkers in a single test (known as next generation sequencing). This will help to reduce costs, increase the number of patients who can have complete testing done, and reduce the need for sample retesting. I also think it’ll continue to be critical for there to be good communication between the laboratory pathologist and treating clinician to ensure the right tests are ordered and undertaken quickly, to reduce the time of initiating tailored treatment plans.^8,9,10

Dr. Anne-Marie Baird, Bsc, PhD is a senior research fellow in Trinity College Dublin and is President of LuCE, a non-profit umbrella organization that aims to provide a voice for people impacted by lung cancer in Europe.

How would you rate current access to lung cancer biomarker testing in Europe?

Depending on the type of lung cancer, availability of biomarker testing is key to selecting the most appropriate treatment option, but access to testing differs widely across and within European countries. There is currently a low adoption of broad panel testing (next generation sequencing) and the use of liquid-based biopsies, and in some instances a lack of reimbursement for biomarker testing. This means that many people impacted by lung cancer are potentially receiving suboptimal care.

What do you think are the biggest barriers for patients when trying to access biomarker testing?

There are a number of barriers that impact testing, and these can range from infrastructure and health system issues, to more simply a lack of availability. We do find in some instances that even where testing is available, it may not necessarily be used. There is a need for better education and awareness around the importance of biomarker testing to determine tumor characteristics and thus increase the chances of accessing an effective targeted therapy. This need applies not just to people impacted by this disease, but also to the clinicians who treat the disease. Biomarker testing in lung cancer is a rapidly evolving and complex space, therefore, there can be difficulties in accessing accurate and up-to-date quality information that is written in easily accessible language. Having access to such information will help people find out more about their disease and help with decisions around their lung cancer care.

What are the biggest needs for lung cancer patients around their care?

Several areas of high unmet need exist in the lung cancer community and these vary widely across Europe from inadequate access to healthcare professionals, diagnostics, therapeutics and clinical trials. One of the goals of treatment is to live longer, however, it should have as limited a negative impact on quality of life as possible. In our most recent LuCE report we found that the emotional wellbeing of 77.2% of caregivers and 52.5% of people with lung cancer has been negatively affected.¹¹ Being able to customize treatment plans to individuals, which includes the supportive care that they need to maximize outcomes, is something we should strive for. At LuCE, we advocate for improvements in all aspects of care and we want a future where geographical location or socioeconomic status does not impact a person’s outcome.

Securing a detailed lung cancer diagnosis at the start of a lung cancer journey, through biomarker testing, is critical in order for clinicians and patients to better understand the characteristics of the cancer as well as make informed decisions and develop a customized care plan. At Amgen, we are committed to bringing promising new therapies to patients with complex cancers, where there remains significant unmet need. We are also supporting efforts around the world to help ensure high quality biomarker testing is accessible for patients with lung cancer – read more about how we are supporting the European Molecular Quality Network (EMQN) External Quality Assurance (EQA) scheme here.

References

¹ European Cancer Information System. Data explorer. Incidence and mortality 2020. EU-27. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-AE27$2-All$4-1,2$3-All$6-0,85$5-2008,2008$7-7,8$CEstByCancer$X0_8-3$CEstRelativeCanc$X1_8-3$X1_9-AE27 Accessed January 2021.

² Lung Cancer Europe. Lung Cancer Our Diagnosis. Available at: https://www.lungcancereurope.eu/lung-cancer/ Accessed January 2021.

³ LunGevity Foundation. Biomarker Testing. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/diagnosing-lung-cancer/biomarker-testing#:~:text=Biomarker%20testing%20(also%20known%20as,PD%2DL1%20protein%20expression%20level. Accessed January 2021.

⁴ESMO. Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment, and follow-up. Annals of Oncology 2018 [Updated September 2020]; 29 (Supp 4): iv192–iv237. Available from: https://www.esmo.org/guidelines/lung-and-chest-tumours/clinical-practice-living-guidelines-metastatic-non-small-cell-lung-cancer

⁵ Lung Cancer Europe. Treatment and clinical trials. Available at: https://www.lungcancereurope.eu/lung-cancer/treatments-and-clinical-trials/ Accessed January 2021.

⁶ Lung Cancer Europe. Types of lung cancer and staging. Available at: https://www.lungcancereurope.eu/lung-cancer/types-of-lung-cancer-and-staging/ Accessed January 2021.

⁷ Scagliotti GV, Bironzo P and Vansteenkiste JF. Addressing the unmet need in lung cancer: the potential of immuno-oncology. Cancer Treat Rev. 2015;41(6):465-475. DOI: 10.1016/j.ctrv.2015.04.001.

⁸ Kerr KM, et al. Second ESMO consensus conference on lung cancer pathology and molecular biomarkers for non-small cell lung cancer. Ann Oncol. 2014;25(9):1681-1690. DOI: 10.1093/annonc/mdu145.

⁹ Dietel M et al. Diagnostic procedures for non-small cell lung cancer (NSCLC): recommendations of the European Expert Group. Thorax. 2016;71:177-184 DOI:10.1136/thoraxjnl-2014-206677.

¹⁰ Pennell, et al. Biomarker Testing for Patients With Advanced Non–Small Cell Lung Cancer: Real-World Issues and Tough Choices. ASCO Educational Book. 2019:531-542

¹¹ Lung Cancer Europe. 5^th LuCE report on lung cancer. Psychological and social impact of lung cancer. 2020. Available at: https://www.lungcancereurope.eu/2020/10/15/5th-edition-of-the-luce-report/ Accessed January 2021.