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Peginterferon

Phase 3

Multiple Myeloma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 4, 2017

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
RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment244
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00732641Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)PHASE3 COMPLETED 244Dec 1, 2000Nov 1, 2010Apr 4, 2017 -
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Study Endpoints
Primary Endpoints
Number of Days With Progression Free Survival (PFS)
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)

PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse. PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse.

Secondary Endpoints
Number of Days of Overall Survival (OS)
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
Number of Participants With Complete Response (CR) to Treatment
Month 9 & Month 18
Number of Participants With Partial Response (PR) to Treatment
Month 9 & Month 18
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Peginterferon α-2bEXPERIMENTALPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
No TreatmentNO_INTERVENTIONParticipants will be observed and will receive no treatment.
Interventions
NameTypeDescription
PeginterferonDRUGPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must demonstrate willingness to participate in the study and to adhere to dose and visit schedules * Must be ≤85 years of age of either sex, and any race * Must have stage II or III multiple myeloma with a histological confirmation consistent with the diagnosis of multiple my...

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Competitive Landscape -Multiple Myeloma 228 trials
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Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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