Courtney Hudson, CEO & Co-Founder of EmergingMed, explains the basics of clinical trials and the process of developing new treatments in the emerging age of personalized medicine and immunotherapy. Lean how to identify appropriate clinical trials, find strategies to determine your best options, and figure out which questions to ask when making your decisions. Watch the accompanying webinar: https://vimeo.com/203510985

1. FACT VS FICTION:
CLINICAL TRIALS FOR OVARIAN CANCER
Courtney Hudson, CEO & Founder, EmergingMedFebruary 9, 2017

2. Agenda
1. How to search for clinical trials?
2. What’s out there?
3. About targeted therapies & tumor
profiling
4. Considerations for phase I clinical trials
5. Discussion & questions
2
www.ShareCancerSupport.org 1.877.769.4832

3. Today’s goal: empower you with information
to successfully explore & access ovarian
cancer research and clinical trials
uClinical trials may/may not be right for you
uExplore clinical trials at every treatment decision
uNEVER required to enroll or stay enrolled
How to search for trials?3
www.ShareCancerSupport.org 1.877.769.4832

4. SHARE Clinical Trial Matching Service
1) Complete profile
2) Update profile
3) Review matches with
Clinical Trial Navigator
4) Talk to trial site(s)
5) Discuss with your doctor
4
www.ShareCancerSupport.org 1.877.769.4832

5. Clinical trials measure, measure, measure
¨ Clinical trials explore risk/benefit of new therapies:
v New drug OR combination OR dosage/sequence
¨ Is experimental therapy better/worse vs. standard placebo
¨ Phases: I, II, III ….and now I/II….II/III
¨ Eligibility:
v Diagnosis, stage, treatment history
v And now tumor biomarkers…Tomorrow?
¨ Interim analysis
5
LESSONS Childhood Leukemia
LEARNED Breast Cancer– BMT & HDC

6. u 50 Phase II or III studies specifically
for ovarian cancer
u 45 Phase I trials specifically for
ovarian cancer patients
u Hundreds of general Phase 1 trials
What’s out there? as of 2/9/20176
www.ShareCancerSupport.org 1.877.769.4832

7. Clinical trials are designed around today’s
treatment strategies
7
3RD LINE…
DIAGNOSIS
OR
SUSPICION
OF
OVARIAN
CANCER
SURGERY
1ST LINE
PLATINUM
BASED
THERAPY
2ND LINE
PLATINUM
RESISTANT
<6 months
benefit
2ND LINE
PLATINUM
SENSITIVE
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
BIOMARKER TESTING

8. Clinical trials offered at all stages
8
3RD LINE…
DIAGNOSIS
OR
SUSPICION
OF
OVARIAN
CANCER
SURGERY
1ST LINE
PLATINUM
BASED
THERAPY
2ND LINE
PLATINUM
RESISTANT
<6 months
benefit
2ND LINE
PLATINUM
SENSITIVE
REMISSION
36
57
52
413
untreated
4
neo-adjuvant
6
adjuvant
Ø 95 unique trials specifically seeking
ovarian cancer patients
50 of 95 are phase II and/or III
Ø Some trials enroll patients at multiple
stages of this journey

9. Identifying biomarkers specific to YOUR
tumor may help you make more informed
decisions today or tomorrow…
Ø … REMAIN ON THE LOOKOUT FOR NEW RESEARCH
AND TARGETED AGENTS SPECIFIC TO YOUR TUMOR’S
GENOMIC PROFILE
About targeted therapies & genomic profiling9
www.ShareCancerSupport.org 1.877.769.4832

10. Today’s landscape in 50 phase II or III
studies specifically for ovarian cancer
10
v No longer takes 10 years to study a drug
v Drug developers may first test new therapies
in ‘easier cancers’ before ovarian
v Consider Phase I trials to find a targeted
therapy???
www.ShareCancerSupport.org 1.877.769.4832

11. Examples of 36 molecular targets being
explored today in ovarian studies
11
www.ShareCancerSupport.org 1.877.769.4832
AR CTLA4 IAP NKG2A TP53
ATR FAK IDO1 PARP (1,2) VEGFR 1,2
AURK FGFR IFN receptors PD-1 , PDL-1 VEGFR2
B7H1 FKBP12 JAK1 PDCD1 WEE1
BET FLK1 JAK2 PDGFR
Cancer
stemness
pathways
FOLR1FR KDR RAFT1
CHK1 FRAP Mesothelin TGFB1
CSF1R HDAC MTOR TGFB2

12. Examples of 29 targeted therapies in
ovarian cancer studies
12
avelumab GSK1120212 olaparib
AZD1775 INCB018424 pazopanib
BBI503 INCB024360 pembrolizumab
bevacizumab IPH2201 PLX3397
BMS-986158 Lenvatinib RG435
cediranib maleate LY2606368 rucaparib
COTI-2 MK-1775 tremelimumab
durvalumab nintedanib veliparib
ENMD-2076 niraparib VX-970
farletuzumab nivolumab
www.ShareCancerSupport.org 1.877.769.4832

13. Considerations for phase I trials13
www.ShareCancerSupport.org 1.877.769.4832

14. Phase I, first-in-human trials and targeted
therapies
¨ 70% vs 10% of all agents move on to Phase II
v Most are targeted; example of IèII
¨ Over 700 in all cancer studies today (vs 45 ovarian)
v Phase I/II or II/III…roll-over
v May need to become patient at phase I site
¨ Are you 1st, 30th, 100th patient?
¨ Anti-cancer activity added as goal
v Along with toxicity, metabolism
14
WARRANTS A FRESH LOOK AT RISK VS. BENEFIT EQUATION

15. Courtney Hudson
chudson@emergingmed.com
To search for trials and get registered:
Thank you and good luck15
www.ShareCancerSupport.org
1.877.769.4832