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tanespimycin

Phase 3

Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 7, 2015

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00546780A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First RelapsePHASE3 COMPLETED 31Feb 1, 2008Mar 1, 2010Jun 28, 201119 United States, Canada
NCT00514371A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple MyelomaPHASE2 COMPLETED 22Aug 1, 2007Feb 1, 2009Dec 7, 201511 United States
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Study Endpoints
Primary Endpoints
Progression-free survival
6-24 months
Objective Response Rate
approximately 3 months
Secondary Endpoints
Overall survival in each arm of the study
Up to 24 months
Response rate between treatment arms and time-to-event endpoints.
Up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AACTIVE_COMPARATORTanespimycin + Bortezomib
Arm BACTIVE_COMPARATORBortezomib
tanespimycin and bortezomibEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
bortezomib and tanespimycinEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
bortezomib tanespimycinEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
Interventions
NameTypeDescription
TanespimycinDRUGSolution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
BortezomibDRUGSolution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Good Performance Status * Documented evidence of multiple myeloma * Documented progression of disease after initial response to one line of therapy * Measurable disease (serum M-protein \>.5g/dl or \> 200 mg urinary M protein excretion) Exclusion Criteria: * Prior treatment ...

Countries:United StatesCanada
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Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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