Partnering with Industry Katherine Y. Look M.D. Medical Fellow I Eli Lilly NCI/GCIG Panel Discussion May 29, 2009

Partnering Industry Perspective What we Bring Novel Molecules Global Presence Advocacy Links Financial support What we Need Timeliness Concept →PA→FPV Regulatory Quality Data Collection Cooperation with CTR Requirements

Pfisterer J et al JCO 2006

Pfisterer J et al JNCI 2006

TFI  12 mos Ferrero JM et al Annals Oncology 2007

CALYPSO Sponsors and Collaborators: ARCAGY/ GINECO GROUP Schering-Plough Arbeitsgemeinschaft Gynaekologische Onkologie Austria AGO Ovarian Cancer Study Group ANZGOG European Organization for Research and Treatment of Cancer NCIC CTG NSGO ClinicalTrials.gov Identifier: NCT Standard Standard Carboplatin AUC 5 every 3 or 4 weeks Paclitaxel 175 mg/m² at day 1 every 3 weeks Experimental Experimental Carboplatin AUC 5 every 3 or 4 week Pegylated liposomal doxorubicin 30 mg/m² every 4 weeks Pegylated liposomal doxorubicin 30 mg/m² every 4 weeks 6 cycles or until progression 6 cycles or until progression

CALYPSO Eligibility Criteria Measurable disease (RECIST) or CA125 assessable disease (GCIG) or Histologically proven Dx of relapse Progression > 6 m after 1 st or 2 nd Platinum based therapy. Prior taxane derivative required. ECOG PS < 2 Adequate organ function Exclusion Criteria LMP tumors Prior RT Prior other malignancy Pre-existing NCI CTCAE neurotox > G1 Severe hypersensitivity to Cb, Pac, Caelyx 1 Outcome Measure: PFS 2 Outcomes Measure(s): Toxicity,QOL,OS Enrollment: 976 Start Date: April 2005 Estimated Completion Date: November accessed May 4http:// accessed May 4, accessed May 4

Challenges Opportunities Intellectual Property Biomarker -Pt Segmentation ContractingDataNDAsNDATimeline(s) Stakeholder dialogue Safe harbor Common Clauses StreamlinedOptimizedStandardized/caBIG Surrogate Endpoints (PFS -Ind/Review-EBM) Curt G; McClellan M, Benner JS; Niederhuber JE The Oncologist 2009 in press

Discussion Common Goals OS, PFS, QOL Gains Rapid Accrual Lessons Learned What is working…. What is slowing us down.. Examples (if desired) - Platin resistant - Front Line therapy

Registration Endpoints: Industry Perspective

Platinum Resistant Recurrent Ovary Cancer Agent/Dose Author/YRRR%M PFS (m)M OS (m) Alimta 500Vergote Alimta 900Vergote Alimta 900Miller L. Doxil 50 vs Topo Gordon L. Doxil 50 vs gemcitabine Mutch L. Doxil 50 vs Trabectedin + L Doxil Monk 08* ESMO, IGCS abstract only NA

Platinum Resistant Ovary Cancer: Proposals UD GOG Phase 3: 2 X 2 Factorial design Docetaxel vs LD with concurrent randomization w/wo VEGF Trap SGCTG ‡ : RP2 N = ○ EP PFS ddCb3T80 3/4wk X 18 vs LD 50 Q4 EORTC ‡ Picoplatin phase 2/3 (Poniard) EORTC ‡ HDAC Inhibitor phase 2 ‡ discussed at GCIG November 2008

GCIG Proposals UD Nov 08 Has FPV Occurred? AGO 12: Cb 5 T 175 vs Cb 5 T 175 BIBF bid N = ○ EP: PFS 2 ○ EP: OS, PFI, CA125, QOL AGO 16: DC lst line +/- Pazopanib (GSK) 1 ○ EP: PFS Schedule: CA125 Q3m X 18 m: CT Q6 FPV = First Patient Visit