Eli Lilly and Company Lilly Corporate Center 2006 Annual ...
Partnering with Industry Katherine Y. Look M.D. Medical Fellow I Eli Lilly NCI/GCIG Panel Discussion...
-
Upload
jodie-joseph -
Category
Documents
-
view
218 -
download
0
Transcript of Partnering with Industry Katherine Y. Look M.D. Medical Fellow I Eli Lilly NCI/GCIG Panel Discussion...
Partnering Partnering with Industrywith Industry
Katherine Y. Look M.D. Katherine Y. Look M.D.
Medical Fellow IMedical Fellow I
Eli Lilly Eli Lilly NCI/GCIG Panel DiscussionMay 29, 2009
Partnering Partnering Industry Industry PerspectivePerspectiveWhat we BringWhat we Bring
Novel MoleculesNovel MoleculesGlobal PresenceGlobal PresenceAdvocacy LinksAdvocacy LinksFinancial supportFinancial support
What we NeedWhat we Need
TimelinessTimeliness
ConceptConcept→PA→FPV→PA→FPV
RegulatoryRegulatory Quality Quality Data Data CollectionCollection
Cooperation with Cooperation with CTR CTR
RequirementsRequirements
Pfisterer J et al JCO 2006
Pfisterer J et al JCO 2006
Pfisterer J et al JNCI 2006
Pfisterer J et al JNCI 2006
TFI 12 mos
Ferrero JM et al Annals Oncology 2007
Ferrero JM et al Annals Oncology 2007
CALYPSOCALYPSO
Sponsors and CollaboratorsSponsors and Collaborators: :
ARCAGY/ GINECO GROUP ARCAGY/ GINECO GROUP
Schering-Plough Schering-Plough
Arbeitsgemeinschaft Arbeitsgemeinschaft Gynaekologische Onkologie Gynaekologische Onkologie Austria AGO Ovarian Cancer Austria AGO Ovarian Cancer Study Group Study Group
ANZGOG ANZGOG
European Organization for European Organization for Research and Treatment of Research and Treatment of Cancer Cancer
NCIC CTG NCIC CTG
NSGO NSGO
ClinicalTrials.gov Identifier: ClinicalTrials.gov Identifier: NCT00189553NCT00189553
StandardStandardCarboplatin AUC 5 every 3 Carboplatin AUC 5 every 3 or 4 weeks or 4 weeks Paclitaxel 175 mg/m² at Paclitaxel 175 mg/m² at day 1 every 3 weeks day 1 every 3 weeks
Experimental Experimental Carboplatin AUC 5 every 3 Carboplatin AUC 5 every 3 or 4 weekor 4 week Pegylated liposomal Pegylated liposomal doxorubicin 30 mg/m² doxorubicin 30 mg/m² every 4 weeks every 4 weeks
6 cycles or until 6 cycles or until progressionprogression
CALYPSOCALYPSO
Eligibility CriteriaEligibility Criteria
Measurable disease (RECIST) Measurable disease (RECIST) oror
CA125 assessable disease (GCIG) CA125 assessable disease (GCIG) oror
Histologically proven Dx of relapseHistologically proven Dx of relapse
Progression > 6 m after 1Progression > 6 m after 1stst or 2 or 2ndnd Platinum Platinum
based therapy. Prior taxane derivativebased therapy. Prior taxane derivative
required.required.
ECOG PS < 2ECOG PS < 2
Adequate organ function Adequate organ function
Exclusion CriteriaExclusion Criteria
LMP tumorsLMP tumors
Prior RTPrior RT
Prior other malignancyPrior other malignancy
Pre-existing NCI CTCAE neurotox > G1Pre-existing NCI CTCAE neurotox > G1
Severe hypersensitivity to Cb, Pac, CaelyxSevere hypersensitivity to Cb, Pac, Caelyx
11•• Outcome Measure Outcome Measure: :
PFSPFS
2 2 • • Outcomes Measure(s): Outcomes Measure(s):
Toxicity, Toxicity,
QOL, QOL,
OSOS
Enrollment: Enrollment: 976976
Start Date: Start Date:
April 2005April 2005
Estimated Completion Date: Estimated Completion Date:
November 2012November 2012
http://www.clinicaltrials.gov/ct2/show/NCT00189553 accessed May 4
, 2009 , 2009
Challenges Challenges OpportunitiesOpportunities
Intellectual Intellectual PropertyPropertyBiomarkerBiomarker-Pt -Pt SegmentationSegmentation
ContractingContracting
DataData
NDANDA
sNDAsNDA
Timeline(s)Timeline(s)
Stakeholder Stakeholder dialogue Safe dialogue Safe harborharbor
Common ClausesCommon Clauses
StreamlinedStreamlined
OptimizedOptimized
Standardized/caBIGStandardized/caBIGSurrogate Endpoints Surrogate Endpoints
(PFS -Ind/Review-EBM)(PFS -Ind/Review-EBM)
Curt G; McClellan M, Benner JS; Niederhuber JEThe Oncologist 2009 in press
DiscussionDiscussion
Common GoalsCommon Goals
OS, PFS, QOL GainsOS, PFS, QOL Gains
Rapid Accrual Rapid Accrual
Lessons Learned Lessons Learned
What is working….What is working….
What is slowing us What is slowing us down..down..
Examples (if desired) Examples (if desired)
-- Platin resistant Platin resistant
- Front Line - Front Line therapytherapy
Registration Endpoints: Registration Endpoints: Industry PerspectiveIndustry Perspective
Platinum Resistant Platinum Resistant Recurrent Ovary Recurrent Ovary CancerCancerAgent/Dose Author/YR RR% M PFS (m) M OS (m)
Alimta 500 Vergote 09 9.3 2.8 11.9
Alimta 900 Vergote 09 10.4 2.8 10.3
Alimta 900 Miller 09 21 2.9 11.4
L. Doxil 50 vs Topo
Gordon 04 12 2.3 8.9
L. Doxil 50 vs gemcitabine
Mutch 07 11.7 3.1 13.5
L. Doxil 50 vs Trabectedin + L Doxil
Monk 08* ESMO, IGCS abstract only
12.2 3.7 NA
Platinum Resistant Platinum Resistant Ovary Cancer: Proposals Ovary Cancer: Proposals UD UD GOGGOG
Phase 3: 2 X 2 Factorial design Phase 3: 2 X 2 Factorial design Docetaxel vs LD with concurrent Docetaxel vs LD with concurrent randomization w/wo VEGF Traprandomization w/wo VEGF Trap
SGCTGSGCTG‡‡: RP2 N = 250 1: RP2 N = 250 1○○EP PFSEP PFSddCb3T80 3/4wk X 18 vs LD 50 Q4ddCb3T80 3/4wk X 18 vs LD 50 Q4
EORTCEORTC‡‡
Picoplatin phase 2/3 (Poniard)Picoplatin phase 2/3 (Poniard)EORTCEORTC‡‡
HDAC Inhibitor phase 2HDAC Inhibitor phase 2
‡‡ discussed at GCIG November 2008 discussed at GCIG November 2008
GCIG Proposals UD Nov 08 GCIG Proposals UD Nov 08 Has FPV Occurred? Has FPV Occurred?
AGO 12AGO 12: : CbCb55TT175 175 vs Cbvs Cb55TT175175 BIBF 1120 200 bid BIBF 1120 200 bid
N = 1300N = 1300
11○○EP: PFS EP: PFS
22○○ EP: OS, PFI, CA125, QOL EP: OS, PFI, CA125, QOL
AGO 16AGO 16: : DC lst line +/- Pazopanib (GSK)DC lst line +/- Pazopanib (GSK)
11○○EP: PFSEP: PFS
Schedule: CA125 Q3m X 18 m: CT Q6Schedule: CA125 Q3m X 18 m: CT Q6
FPV = First Patient Visit