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Precision Endpoints for Contemporary Precision Oncology Trials

Regina Hoo1,2,3, Kevin L M Chua4,5, Pankaj Kumar Panda6

  • 1Division of Medical Oncology, National Cancer Centre Singapore, Singapore.

Cancer Discovery
|April 4, 2024
PubMed
Abstract

Insights

Traditional clinical trial endpoints miss key treatment effects. Mechanism-driven biomarkers and surrogate endpoints offer better insights into anti-tumor activity for precision therapies.

Area of Science:

  • Oncology
  • Pharmacology
  • Biomarker Research

Background:

  • Traditional clinical trial endpoints like progression-free survival and overall survival are insufficient for evaluating novel therapeutic interventions.
  • These standard metrics do not fully capture the complex pharmacologic and pharmacodynamic actions of treatments.

Purpose of the Study:

  • To highlight the limitations of current aggregated clinical trial data for precision therapy decisions.
  • To advocate for the integration of mechanism-driven biomarkers and surrogate endpoints.

Main Methods:

  • Review of existing clinical trial methodologies and endpoint limitations.
  • Conceptual framework for incorporating orthogonal readouts.

Main Results:

  • Traditional endpoints fail to capture the full spectrum of treatment effects.
  • Mechanism-driven biomarkers and surrogate endpoints provide valuable, individualized anti-tumor activity data.
  • Relying solely on aggregated trial data hinders effective go/no-go decisions for precision therapies.

Conclusions:

  • There is a critical need to move beyond traditional endpoints in clinical trials.
  • Integrating mechanism-driven biomarkers and validated surrogate endpoints is essential for precise therapeutic evaluation.
  • Individual-level data from these novel endpoints can improve decision-making for precision medicine.

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