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"Companion diagnostics": has their time come and gone?
Fred R Hirsch1, Paul A Bunn2, Roy S Herbst3
1Department of Medicine and Pathology, University of Colorado Cancer Center, Aurora, Colorado. fred.hirsch@ucdenver.edu.
Summary
Companion diagnostics are crucial for targeted cancer therapies but can cause delays. This study questions whether negative results in advanced non-small cell lung cancer trials were due to the drug or the companion diagnostic.
Area of Science:
- Oncology
- Pharmacology
- Biomarkers
Background:
- The rapid advancement of molecularly targeted drugs necessitates the concurrent development of companion diagnostics.
- Companion diagnostics can potentially delay drug development and restrict patient access to effective treatments.
Purpose of the Study:
- To investigate whether negative outcomes in MetMab studies for advanced non-small cell lung cancer (NSCLC) resulted from drug inefficacy or the inadequacy of the companion diagnostic used.
Main Methods:
- Review of MetMab clinical trial data in advanced NSCLC patients.
- Analysis of the performance and appropriateness of the companion diagnostic employed in the MetMab studies.
Main Results:
- Negative trial results may stem from issues with the companion diagnostic rather than the therapeutic agent itself.
- The study highlights the critical role of accurate companion diagnostics in interpreting clinical trial outcomes.
Conclusions:
- The efficacy of targeted therapies like MetMab in NSCLC is heavily reliant on the precision of companion diagnostics.
- Re-evaluation of diagnostic strategies is essential to ensure appropriate patient selection and avoid premature drug discontinuation.
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