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Clinical Perspective

Clinical Perspective. Where Biomarkers Can Make a Difference. normal. Evidence of Disease. Disability Death. Screening/Prevention Who is at risk for what type. Decision to Intervene: Risk Assessment. Treatment What type and when. Problems/opportunities. Tumor heterogeneity

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Clinical Perspective

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  1. Clinical Perspective

  2. Where Biomarkers Can Make a Difference normal Evidence of Disease Disability Death Screening/Prevention Who is at risk for what type Decision to Intervene: Risk Assessment Treatment What type and when

  3. Problems/opportunities • Tumor heterogeneity • Along a spectrum of indolent to aggressive • From early to late risk for recurrence • Among patients with high risk for early recurrence • Within a given tumor • For those at risk, standard therapy has made a difference, but not all benefit equally or at all • There are hundreds of agents in the pipeline but limited ability to test them • Biomarkers/ Companion Diagnostics for targeted agents are lacking

  4. Women at Risk for Early Systemic Recurrence of Breast Cancer Biomarker: 70 gene high risk • Are unlikely to be cured with surgery alone • Order of surgery, systemic therapy has no impact on survival outcomes • Neoadjuvant approach is an opportunity • Downstage tumors, refine local therapy options • Better understand response to therapy, prognosis • Accelerate targeted drug development to improve outcomes in highest risk women • Particularly relevant as a tool to sort out optimal treatments in the molecular era

  5. Acceleration ofKnowledge Turns MARKER PHASE Full Approval SCREENING PHASE Adapts on drugs (~60 patients) CONFIRMATORY PHASE Adapts on biomarker (~300 patients) Accelerated Approval for Agent/ Approval for biomarker/PMA pCR not confirmed Agent Enters New agent/combination qualifies and is approved for I-SPY 2

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