clinical trials: fact vs. fiction, courtney hudson, ceo & co-founder, emergingmed
TRANSCRIPT
Clinical Trials: Fact vs. Fiction
understand your options and the right timing
to consider clinical trials Presented by Courtney Hudson, CEO & Founder, EmergingMed
Ovarian Cancer National Conference | Washington, DC | July 9, 2016
Agenda
1. The basics of clinical trials2. When to search3. What’s available4. About targeted therapies & genomic
profiling5. Considerations for phase I clinical
trials6. Discussion & questions
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What are clinical trials? Measurements of benefits/risks of new
therapies New drug OR drug combination OR
modality OR dosage/sequence OR patient population
Is experimental therapy better or worse or same
Interim analysis and ongoing reviews1.800.535.1682
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What are clinical trials? Enrollment criteria:
Diagnosis, stage, treatment history, genomic profile
Regimens vs. cycles Phases: 1 1/2 2 2/3 3 Informed consent: you may leave
anytime
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Clinical trials may/may not be right for you
Today’s goal: arm you with information to successfully navigate the fast-changing world of ovarian cancer research & clinical trials
Explore clinical trials at each treatment decision
When to search for trials5
OCRFA Clinical Trial Matching Service1. Call a Clinical Trial Navigator
1.800.535.16822. Complete/update profile3. Call trial sites to learn more about trial
matches 4. Review trial matches with your medical
team5. Other resources: ClinicalTrials.gov, your
hospital’s website
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What’s Available7
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Studies specifically for ovarian cancer
41 phase 2 and phase 3 studies
16 targeted therapies25 unique targets
&Hundreds of agents in phase I
trialsas of July 8, 2016
Source: EmergingMed database, ClinicalTrials.gov
Clinical trials mirror treatment paradigm
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3RD LINE…
DIAGNOSIS OR
SUSPICION OF
OVARIAN CANCER
SURGERY
1ST LINE PLATINU
M BASED THERAP
Y 2ND LINEPLATINU
M RESISTA
NT<6
months benefit
2ND LINEPLATINU
M SENSITIV
E
REMISSION
1. Clinical trials expect you receive standard of care (vs. off-label)
2. Narrow window of time to enroll
CONTINUED
REMISSION
SEND TISSUE FOR GENOMIC TESTING
Clinical trials offered at each defined stage
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3RD LINE…
DIAGNOSIS OR
SUSPICION OF
OVARIAN CANCER
SURGERY
1ST LINE PLATINU
M BASED THERAP
Y 2ND LINEPLATINU
M RESISTA
NT<6
months benefit
2ND LINEPLATINU
M SENSITIV
E
REMISSION
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24
12
16
untreated
…AND HUNDREDS OF
PHASE I SOLID TUMOR
TRIALS
The business of developing cancer therapies
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No longer takes 10 years to study a drug
Drug developers may first test new therapies in ‘easier cancers’ before ovarian
Phase I trials for more targeted therapies
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Identifying biomarkers specific to your tumor may help you make more informed decisions today…and tomorrow
DNA—RNA—Proteins
About targeted therapies & genomic profiling12
25 molecular targets across 41 ovarian cancer phase II, III studies (as of 7/8/2016)
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Androgen receptor FLK1 PDGFR
Aromatase FR-alpha SRCBCR/ABL* (BRCA) HIF1-alpha TOP1Cancer stemness
pathways IL2R TOP2CDK4 KDR tubulinCDK6 NADPH VEGFRCHK1 PARP VEGFR2CSK PD-1 Wee1FGFR PDGFR 1.800.535.1682
16 targeted therapies in these 41 studies
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Unique Targeted Agents US brand name Unique Targeted
AgentsUS brand
name rhuMAb-VEGF / RG435 niraparib
TLC D-99 Doxil, Dox-SL, LipDox, Evacet olaparib Lynparza
bevacizumab Avastin palbociclib Ibrancecediranib Recentin pazopanib Votrientdenileukin difitox Ontak pembrolizumab Keytrudafarletuzumab prexasertibdurvalumab (MEDI4736) regorafenib Stivarganintedanib veliparib
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Considerations for Phase I trials
Are you 1st, 30th, or 100th patient? First-in-human or testing target
Safety and dosage are tested first, 3-by-3
Anti-cancer activity added as goal 70%+ of all agents move on to
Phase II Over 900 targeted agents in all
cancer studies today (vs 16)WARRANTS A FRESH LOOK AT RISK VS. BENEFIT EQUATION?
OCRFA Clinical Trial Matching Service1. Call a Clinical Trial Navigator
1.800.535.16822. Complete/update profile3. Call trial sites to learn more about trial
matches 4. Review trial matches with your medical
team5. Other resources: ClinicalTrials.gov, your
hospital’s website
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