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KOS-1584

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 17, 2016

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 Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651508Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)PHASE2 COMPLETED 1Apr 1, 2008Oct 1, 2008May 17, 20161 United States
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Study Endpoints
Primary Endpoints
Objective response rate of KOS-1584
up to one year
Secondary Endpoints
Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.
up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Arm 25mg/m2EXPERIMENTALKOS-1584 25mg/m2
Interventions
NameTypeDescription
KOS-1584DRUG25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV. * Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC. * Good performance status. Exclusion Criteria: * Prior treatment with an epothilone. * Known central nervo...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
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Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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