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Missing the target in cancer therapy

Jacob J Adashek1, Alexey Goloubev2, Shumei Kato3

  • 1Department of Internal Medicine, University of South Florida, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.

Nature Cancer
|August 9, 2021
PubMed

Insights

Molecular biomarkers improve cancer therapy outcomes and drug approvals. However, many clinical trials exclude patients lacking these essential biomarkers, hindering progress for lethal malignancies.

Area of Science:

  • Oncology
  • Translational Medicine
  • Biomarker Discovery

Background:

  • Molecular biomarkers are crucial for predicting patient response to targeted cancer therapies.
  • Current clinical trials often enroll patients without biomarkers, limiting treatment efficacy and drug development.

Purpose of the Study:

  • To highlight the critical role of molecular biomarkers in precision oncology.
  • To address the challenge of biomarker-negative patient populations in cancer clinical trials.

Main Methods:

  • Review of current clinical trial methodologies in oncology.
  • Analysis of biomarker-driven therapy versus standard care outcomes.
  • Examination of drug approval success rates based on biomarker utilization.

Main Results:

  • Biomarker-guided therapies significantly improve patient outcomes and survival rates.
  • Exclusion of biomarker-positive patients in trials leads to suboptimal drug development and approval.
  • Targeted therapies show higher efficacy when administered to biomarker-selected patient cohorts.

Conclusions:

  • Integrating molecular biomarkers into clinical trials is essential for advancing precision cancer medicine.
  • Addressing the challenge of biomarker-negative patients requires innovative trial designs and biomarker discovery efforts.
  • Widespread adoption of biomarker-based patient stratification will accelerate the development of effective cancer treatments.

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