Progress and Opportunities to Advance Clinical Cancer Therapeutics Using Tumor Dynamic Models
René Bruno1, Dean Bottino2, Dinesh P de Alwis3
1Genentech-Roche, Marseille, France. rene.bruno@roche.com.
Abstract:
There is a need for new approaches and endpoints in oncology drug development, particularly with the advent of immunotherapies and the multiple drug combinations under investigation. Tumor dynamics modeling, a key component to oncology "model-informed drug development," has shown a growing number of applications and a broader adoption by drug developers and regulatory agencies in the past years to support drug development and approval in a variety of ways. Tumor dynamics modeling is also being investigated in personalized cancer therapy approaches. These models and applications are reviewed and discussed, as well as the limitations and issues open for further investigations. A close collaboration between stakeholders like clinical investigators, statisticians, and pharmacometricians is warranted to advance clinical cancer therapeutics.
Insights
Tumor dynamics modeling is crucial for advancing oncology drug development, especially with new immunotherapies and combination treatments. This approach aids drug approval and personalized cancer therapy, requiring collaboration among experts.
Area of Science:
- Oncology
- Pharmacometrics
- Drug Development
Background:
- The evolution of cancer treatments, including immunotherapies and combination therapies, necessitates novel approaches in drug development.
- Tumor dynamics modeling is increasingly adopted by pharmaceutical companies and regulatory bodies.
- This modeling is also being explored for personalized cancer treatment strategies.
Purpose of the Study:
- To review and discuss the applications of tumor dynamics modeling in oncology drug development.
- To highlight the growing role of model-informed drug development (MIDD).
- To identify limitations and areas for future research in tumor dynamics modeling.
Main Methods:
- Review of current literature and applications of tumor dynamics modeling.
- Discussion of the integration of modeling into drug development and regulatory processes.
- Exploration of the use of these models in personalized medicine.
Main Results:
- Tumor dynamics modeling supports oncology drug development and approval in various capacities.
- Significant adoption of these modeling techniques by industry and regulatory agencies.
- Emerging applications in personalized cancer therapy approaches.
Conclusions:
- Tumor dynamics modeling is a valuable tool in modern oncology drug development.
- Continued research is needed to address current limitations and expand applications.
- Enhanced collaboration among clinical investigators, statisticians, and pharmacometricians is essential for progress.
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