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AEZS-108

Phase 2

Ovarian Cancer | Small molecule | Oncology |COSCIENS Biopharma Inc.|Last Updated: Dec 13, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00569257Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological TumorsPHASE2 COMPLETED 85 — — Dec 1, 2007Jul 1, 2011Dec 13, 201117 Bulgaria, Germany
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Study Endpoints
Primary Endpoints
Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
up to six 3-weekly treatment cycles
Secondary Endpoints
Time-to-progression (TTP); Overall survival
up to observation of event
Safety of AEZS-108 (possibly drug-related adverse events)
4 weeks beyond last drug admnistration
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AEZS-108DRUGintravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor * Histologically confirmed epithelial ovarian cancer (Stratum A) * Advanced (FIGO III or IV) or recurrent disease * Progression during treatment with a platinum-...

Countries:BulgariaGermany
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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
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Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
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Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
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Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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