Beyond ALK & EGFR: Shifting the treatment paradigm of early-stage NSCLC

With more than 25 FDA approved therapies that target genomic mutations, treatment options for patients with non-small cell lung cancer (NSCLC) have improved considerably in the last 20 years. These target therapies dramatically improve clinical outcomes and save lives, but only when biomarker testing is performed to identify the genomic drivers that underlie each patient’s tumor.

A new study from Biofidelity is examining how its Aspyre technology can bridge the gaps in clinical care that prevent early-stage NSCLC patients from receiving molecular profiling and, as a result, highly effective targeted therapies.

“Advancing genomic testing for early-stage resectable NSCLC patients is crucial, and this study offers two opportunities: additional research about actionable mutations in this population and the assessment of a new platform with the potential to improve patient care,” said Dr. Shetal Patel from the University of North Carolina.

Read on to see how you can join this study and help expand testing options for Early Stage NSCLC.

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Identifying additional actionable mutations in early-stage NSCLC

Patients with resectable stage IB-IIIA, IIIB (T3, N2) NSCLC are usually only offered testing for ALK and EGFR mutations to determine their eligibility for neoadjuvant therapy. However, data suggests these early-stage patients may harbor additional actionable mutations. In fact, the International Association for the Study of Lung Cancer now “highly encourages” biomarker testing for oncogenic drivers other than EGFR and ALK alterations in patients with early-stage disease.¹

In this new study, researchers will use the highly sensitive Aspyre Clinical Test for Lung tissue assay to identify additional actionable mutations in this patient population, offering a unique opportunity to gather data in a timely and cost-effective manner.  The information may then be used to design future definitive clinical trials that aim to expand the list of actionable genomic alterations for this patient population, which could make targeted treatment options available to a larger group of patients.

“Ultimately, the results of this study can be used in future studies that will empower us to tailor treatments more precisely, improve outcomes and enhance the quality of life for patients with early-stage NSCLC,” Dr. Patel continued.

Bridging the Treatment Gaps

Aspyre Clinical Test for Lung has the potential to improve on the existing gaps in clinical care for early-stage NSCLC patients². These gaps exist due to a number of limitations with next generation sequencing (NGS) assays, the current standard for molecular profiling.

Turnaround Time (TAT)

This study will measure the time to genomic result availability of Aspyre Clinical Test for Lung, which is currently advertised as 48 hours. In contrast, NGS testing for EGFR mutations and ALK rearrangements typically have a TAT of 10 business days following receipt of the sample, often resulting in delayed clinical decision-making.

Limited Tissue Availability and Sample Quality

Tissue biopsies from early-stage patients are usually small in size. NGS assays have strict input requirements, often resulting in nearly 15% of these tissue samples untested due to insufficient quantity³. NGS is also sensitive to sample quality, with up to 25% of tissue samples failing assay quality control (QC)^2,3,4. Aspyre Clinical Test for Lung has less stringent sample input requirements, with evidence that Aspyre Clinical Test for Lung can handle low quality samples in addition to other sample preparation types generally not amenable to NGS sequencing⁵.

Cost Effectiveness

NGS is comprehensive genomic testing that produces far more information beyond the small number of actionable mutations that are potentially present in early-stage NSCLC, making such broad-based testing unreasonably expensive. If you are interested in participating in this important research and subsequent publication, or would like more information, email e.shapiro@biofidelity.com. A full study synopsis can be found here.

References

1. Jonathan D. Spicer et al. Neoadjuvant and Adjuvant Treatments for Early Stage Resectable NSCLC: Consensus Recommendations From the International Association for the Study of Lung Cancer. J of Thoracic Oncology. June 18, 2024.

2. Sadik H, Pritchard D, Keeling D-M, et al: Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer [Internet]. JCO Precis Oncol 6:e2200246, 2022 Available from: https://ascopubs.org/doi/full/10.1200/PO.22.00246

3. Tsimberidou A, Sireci A, Dumanois R, Pritchard D. Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care. JCO Oncol Pract. 20:761-766, 2024. doi: 10.1200/OP.23.00601

4. Hagemann IS, Devarakonda S, Lockwood CM, et al: Clinical next‐generation sequencing in patients with non–small cell lung cancer. Cancer 121:631–639, 2015

5. Shapiro E, Evans R, Gillon-Zhang E, Brown J, King C, Kiser C, Rossi M, Davis D, Taylor M, Clower, J, Yang J, Taylor C, Snyder R, Levin W. ASPYRE-Lung addresses critical gaps in NGS-based biomarker testing: robust variant calling from NGS QC fails. Poster presented at: The American Association for Cancer Research Annual Meeting, April, 2024; San Diego CA.