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Developing biomarker-specific end points in lung cancer clinical trials
Joel W Neal1, Justin F Gainor2, Alice T Shaw2
1Department of Medicine, Division of Oncology, Stanford Cancer Institute and Stanford University School of Medicine, Stanford University, 875 Blake Wilbur Drive, Stanford, CA 94305, USA.
Nature Reviews. Clinical Oncology
|December 24, 2014
Summary
Traditional cancer trial endpoints like overall survival have limitations. Novel biomarkers offer a promising alternative to accelerate drug development and improve patient outcomes in lung cancer research.
Area of Science:
- Oncology
- Clinical Trials
- Biomarker Discovery
Background:
- Traditional efficacy endpoints in cancer drug development, including overall survival (OS) and progression-free survival (PFS), face significant limitations.
- Evaluating OS is time-consuming, and radiographic surrogates like PFS may not accurately reflect benefit with novel immunotherapies due to atypical response kinetics.
Purpose of the Study:
- To review the limitations of current endpoints in lung cancer clinical trials.
- To explore the potential of novel biomarkers as surrogate endpoints to accelerate drug development and improve patient outcomes.
Main Methods:
- Discussion of current limitations of traditional endpoints (OS, PFS, radiographic response).
- Exploration of emerging biomarkers including functional imaging, circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and pharmacodynamic markers.
- Focus on application in lung cancer clinical trials.
Main Results:
- Biomarker-based endpoints can potentially reduce the size, duration, and complexity of cancer trials.
- Biomarkers offer a way to overcome limitations of traditional endpoints, especially for immunotherapies.
- Accelerated drug development and improved patient outcomes are anticipated.
Conclusions:
- There is a critical need for alternative or surrogate endpoints in lung cancer clinical trials.
- Biomarker-based endpoints hold significant promise for streamlining the drug development process.
- Adoption of novel biomarkers could lead to faster delivery of effective cancer therapies to patients.
