Timely Biomarker Testing in NSCLC Informs Treatment Selection

“Non-small cell lung cancer is a very common cancer diagnosed in men and women and is the most frequent cause of cancer-related deaths in both men and women,” Lee Schwartzberg, MD, notes. “Moreover, the majority of patients are diagnosed with advanced disease and need systemic therapy.”

Developments in precision medicine in the past decade have shown that over half of all advanced cases of NSCLC have a specific driver alteration, according to Dr. Schwartzberg, who has published studies on the use of biomarker testing in NSCLC and other cancers. “These alterations can be targeted with a specific drug to inhibit the cancer and control it,” he says. “Further, each of these driver alterations has a validated biomarker test to accurately identify the alteration.”

Physician’s Weekly spoke with Dr. Schwartzberg to learn more about the use of biomarker testing in patients with NSCLC, both in the early and late stages of the disease.

PW: Why is it important to perform biomarker testing in patients with NSCLC?

Dr. Schwartzberg: The advent of next-generation sequencing has made comprehensive genomic profiling (CGP) both cost-effective and more accurate in identifying these biomarkers. Therefore, all patients with advanced lung cancer should have CGP before initiating any therapy to ensure the optimal, precision treatment is offered to an individual.

How does testing vary in early versus later stages of disease?

Early-stage NSCLC has traditionally been treated with surgery followed by adjuvant chemotherapy, which afforded a modest reduction in risk of relapse and improved survival. The recent ADURA trial definitively demonstrated that patients with an alteration in the EGFR gene, which is present in 15% to 20% of NSCLC cases, had a 50% improvement in long-term survival when given a targeted agent after surgery with or without chemotherapy. Additionally, adjuvant treatment with immunotherapy added to chemotherapy shows the largest benefit in patients who have a positive biomarker test for PD-L1. EGFR alterations can be detected by single gene assay or CGP, with the latter being more accurate. While not the standard of care yet, clinical trials are investigating the adjuvant use of other driver alteration inhibitors, which would then support uniform utilization of CGP in both early and advanced cases.

Is biomarker testing common practice for patients with NSCLC?

Yes, but it is far from universal. There remains a gap in biomarker testing, which means that many patients who could benefit greatly from the right precision therapy are not aware of this potential. Some patients also start on standard chemotherapy before biomarker testing is performed and reported, potentially exposing them to unnecessary toxicity.

What steps are needed to improve biomarker testing for these patients?

There are several potential barriers to biomarker testing that should be systematically explored in every care setting. The availability of tissue necessary for appropriate testing is one issue, which can be overcome by liquid biopsy if necessary. The timing of testing is also complicated by whether a patient is diagnosed as an inpatient or outpatient because of the vagaries of reimbursement. Most importantly, every oncologist and multidisciplinary lung cancer care team should be dedicated to solving care path problems that prevent patients with NSCLC from receiving timely biomarker testing to inform initial and subsequent treatment choices. Optimizing biomarker testing for NSCLC can literally make the difference between life and death for our patients.