Transcript ISPY3 - National Biomarker Development Alliance (NBDA)

Clinical Perspective
Where Biomarkers Can Make a
Difference
Decision to
Intervene:
normal
Evidence
of
Disease
Disability
Death
Opportunity #1: Fate
Regression, Stability, Progression
Opportunity #2: Rate
Slow, Moderate, Fast
Opportunity #3: intervention/reverse fate
Targeted to biologic subtype
Screening/Prevention
Who is at risk for what type
Treatment
What type and when
Risk
Assessment
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
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
Feedback
to
consortium
Analysis of
biomarker
data
Drug
graduates
Agreement
on
candidate
marker
MARKER
PHASE
Promising
qualifying
biomarker
Acceleration of
Knowledge Turns
File
IDE
Identify next
agent
combination
3 YR RFS
confirms
SCREENING
pCR result
PHASE
CONFIRMATORY
ContinuousAdapts on drugs
enrollment
PHASE
(~60 patients)
Enroll,
on biomarker
randomize Adapts
pCR
(~300 patients)
I-SPY 2 TRIAL
on
amendment
signal
approved
qualifying
confirmed
biomarkers
or is dropped
Surgical
Therapy to
Confirm
pCR
Agent Enters
New agent/combination qualifies
and is approved for I-SPY 2
pCR not
confirmed
Full
Approval
Accelerated
Approval for
Agent/
Approval for
biomarker/PMA