Clinical trials and biomarker development with molecularly targeted agents and radiotherapy

Neesha Dhani1, Lillian L Siu

  • 1Princess Margaret Hospital, Division of Medical Oncology and Hematology, Department of Medicine, University of Toronto, Toronto, ON, Canada.

Abstract

Insights

Conventional drug development models may not suit targeted cancer therapies. Utilizing genomic and proteomic profiling can accelerate the development of effective oncology treatments by identifying biomarkers for patient selection and improved clinical efficacy.

Area of Science:

  • Oncology
  • Pharmacology
  • Biomarker Discovery

Background:

  • Traditional cytotoxic chemotherapy drug development paradigms may be suboptimal for molecularly targeted agents.
  • Targeted agents often exhibit improved therapeutic indices and reduced toxicity to normal tissues compared to conventional chemotherapeutics.

Purpose of the Study:

  • To address the need for expedited drug development in oncology for novel therapeutics.
  • To optimize the selection of investigational agents with higher potential for clinical benefit.

Main Methods:

  • Leveraging high-throughput genomic, proteomic, and metabolomic profiling techniques.
  • Identifying biomarkers or indicators of treatment response through advanced profiling.

Main Results:

  • Preclinical investigations can be made more effective through advanced profiling.
  • Biomarker identification facilitates better patient selection and treatment response prediction.

Conclusions:

  • High-throughput profiling enables more efficient preclinical evaluation of targeted oncology therapeutics.
  • Validating novel endpoints is crucial for accelerating the drug development and approval process for targeted therapies in oncology.

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