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Published on: March 20, 2021
Opportunities posed by novel patient selection biomarker approaches in oncology drug development: going beyond the
Grant Sellar1, John D Alvarez, Frank Loganzo
1Wyeth Research, Translational Medicine, 500 Arcola Road, Collegeville, PA 19426, USA.
Abstract:
An area of unmet medical need in clinical oncology has been optimizing patient selection for a given therapeutic with the goal of getting the right drug to the right patient. Recent studies have developed preclinical approaches to identifying molecular 'signatures of resistance' for cytotoxic therapies and prospective validation of this strategy is ongoing in the clinic. New challenges in this setting include identifying approaches to patient selection for cytostatic compounds such as signaling pathway inhibitors and stem cell targets. Here, we discuss the biomarker methodologies developed using traditional cytotoxic drugs and how these approaches can be adapted to identify biomarkers of patient selection for novel signaling inhibitors and other novel targets. It has become increasingly clear that such biomarker discovery and validation needs to begin early and continue throughout the drug development process.
Insights
Optimizing cancer therapy involves selecting the right patient for the right drug. This research adapts biomarker discovery methods from cytotoxic drugs to identify patient selection strategies for novel targeted therapies.
Area of Science:
- Oncology
- Translational Medicine
- Biomarker Discovery
Background:
- Patient selection for cancer therapeutics remains an unmet medical need.
- Preclinical models have identified molecular resistance signatures for cytotoxic therapies.
- Selecting patients for novel cytostatic agents, like signaling pathway inhibitors, presents new challenges.
Purpose of the Study:
- To discuss biomarker methodologies for patient selection in oncology.
- To adapt existing biomarker strategies for novel targeted therapies.
- To emphasize the importance of early and continuous biomarker discovery and validation.
Main Methods:
- Review of biomarker methodologies developed for traditional cytotoxic drugs.
- Adaptation of these methodologies for novel signaling inhibitors and other targets.
- Discussion of preclinical and clinical validation strategies.
Main Results:
- Biomarker discovery for cytotoxic drugs has advanced significantly.
- These approaches can be adapted for patient selection in targeted cancer therapy.
- Early and ongoing biomarker development is crucial for successful drug implementation.
Conclusions:
- Biomarker-driven patient selection is essential for optimizing cancer treatment.
- Methodologies for cytotoxic drug biomarkers can inform strategies for novel targeted agents.
- Continuous biomarker discovery and validation throughout drug development are critical.
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