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  11. The Esmo Tumour-agnostic Classifier And Screener (etac-s): A Tool For Assessing Tumour-agnostic Potential Of Molecularly Guided Therapies And For Steering Drug Development

The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development

C B Westphalen1, D Martins-Branco2, J R Beal3

  • 1Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Munich; German Cancer Consortium (DKTK), partner site Munich, German Cancer Research Center (DKFZ), Heidelberg, Germany.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|August 26, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Defining minimum requirements for tumour-agnostic drug development is crucial. The study proposes a screening tool and taxonomy for molecularly guided treatment options (MGTOs) to assess tumour-agnostic potential.

Keywords:
biomarkersclassificationdrug developmentmolecular targeted therapy

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Area of Science:

  • Precision oncology
  • Molecularly guided treatment options (MGTOs)
  • Drug development

Background:

  • Precision oncology has advanced, leading to tumour-agnostic molecularly guided treatment options (MGTOs).
  • However, clear minimum requirements for establishing tumour-agnostic potential are lacking.

Purpose of the Study:

  • To optimize tumour-agnostic drug development.
  • To define minimum requirements for assessing tumour-agnostic potential.
  • To develop a screening tool and taxonomy for MGTOs.

Main Methods:

  • International experts reviewed regulatory data for approved tumour-agnostic indications.
  • Scenarios for minimum objective response rate (ORR), tumor types, and patient numbers were assessed.
  • A screening tool was developed and tested on recent approvals.
  • A taxonomy for MGTOs and a framework for development were conceptualized.

Main Results:

  • Tumour-agnostic indications showed an ORR ≥ 20% in at least 4 tumor types, with ≥5 evaluable patients each.
  • These criteria may serve as a screening tool for tumour-agnostic potential.
  • A taxonomy classifying MGTOs as tumour-agnostic, tumour-modulated, or tumour-restricted was proposed.

Conclusions:

  • The ESMO Tumour-Agnostic Classifier (ETAC) highlights the interaction between molecular targets and tumor biology.
  • Proposed minimum requirements (ETAC-S) can screen for tumour-agnostic potential in drug development.
  • Further definition of ETAC cut-offs is needed.
tumour-agnostic