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Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Clinical Trials in Non-Small Cell Lung Cancer with Biomarker-Driven Treatment Allocation: Ready or Not, Here We Come
Edward B Garon1, Phillip A Abarca2, Jennifer L Strunck1
1Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA.
Abstract:
Lung cancer is the leading cause of cancer mortality. Great advances in non-small cell lung cancer therapy have been seen in the last decade, beginning with the success in treating lung cancer harboring EGFR mutations and ALK-gene rearrangements. The potential of these biomarker-driven therapies has propelled research in biomarker targeted approaches to the forefront of lung cancer research. The successful development of immunotherapeutic agents targeting PD-L1 and PD-1 with an associated non-genomic biomarker has opened a new front in the effort for targeted approaches. Although early-phase lung cancer studies have hinted at the potential to use biomarkers to select patients for allocation to treatment in the conduct of clinical trials, data from late-phase studies have tempered expectations. The data leave unclear the wisdom of routinely restricting enrollment on lung cancer clinical trials to biomarker restricted populations, particularly non-genomic biomarkers.
Insights
Biomarker-targeted therapies show promise for lung cancer treatment, but late-phase trials suggest caution in restricting clinical trial enrollment to biomarker-selected populations, especially for non-genomic biomarkers.
Area of Science:
- Oncology
- Translational Research
- Clinical Trial Design
Background:
- Lung cancer remains a leading cause of cancer mortality globally.
- Significant therapeutic advances in non-small cell lung cancer (NSCLC) have emerged, driven by targeted therapies for EGFR mutations and ALK rearrangements.
- Immunotherapies targeting PD-1/PD-L1, often with non-genomic biomarkers, represent a new frontier in NSCLC treatment.
Purpose of the Study:
- To evaluate the utility of biomarker-driven approaches in NSCLC therapy.
- To assess the impact of biomarker selection on clinical trial enrollment and outcomes.
- To determine the effectiveness of restricting clinical trial access based on genomic and non-genomic biomarkers.
Main Methods:
- Review of recent advances in NSCLC targeted therapies and immunotherapies.
- Analysis of data from early- and late-phase clinical trials investigating biomarker-selected patient populations.
- Examination of the role of both genomic and non-genomic biomarkers in patient stratification.
Main Results:
- Biomarker-targeted therapies, including those for EGFR and ALK, have shown success in NSCLC.
- Immunotherapies targeting PD-1/PD-L1 have expanded treatment options.
- Late-phase trial data indicate that restricting NSCLC clinical trial enrollment to biomarker-defined groups, particularly non-genomic biomarkers, may temper expectations and warrants careful consideration.
Conclusions:
- While biomarker-driven therapies have revolutionized NSCLC treatment, their application in clinical trial design requires nuanced evaluation.
- The routine restriction of clinical trial enrollment to biomarker-selected populations, especially those based on non-genomic markers, is not consistently supported by late-phase data.
- Further research is needed to optimize biomarker strategies for NSCLC clinical trials and ensure broad patient benefit.
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