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Clinical Trials for Ovarian Cancer: Fact vs. Fiction

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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

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Clinical Trials for Ovarian Cancer: Fact vs. Fiction

  1. 1. FACT VS FICTION: CLINICAL TRIALS FOR OVARIAN CANCER Courtney Hudson, CEO & Founder, EmergingMedFebruary 9, 2017
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 13. Considerations for phase I trials13 www.ShareCancerSupport.org 1.877.769.4832
  14. 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. 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

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