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Peginterferon

Phase 3

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

Peginterferon development status

Highest phase Phase 3
Registered trials 4 across 4 sponsors since Nov 2005

Peginterferon target and mechanism

Molecular targetIFNAR1, IFNAR2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment244

FDA Designations

No designations recorded

Peginterferon clinical trials

Peginterferon · 1 trial · 1 indication

Phase 3 1
NCT00732641Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)Multiple Myeloma
COMPLETED244 Analytics
PHASE3COMPLETED
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Multiple MyelomaUnlock trial analytics

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 to 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 338 trials

Frequently asked questions about Peginterferon

What is Peginterferon used for?

Peginterferon is being studied as a maintenance therapy for people with multiple myeloma who have responded to induction therapy. It is an oncology asset developed by Merck & Company, Inc. under the ticker MRK. The program is in Phase 3 development, and the single registered trial in this indication has completed.

What does Peginterferon target?

Peginterferon targets IFNAR1 and IFNAR2, the two subunits of the type I interferon receptor. It acts as an agonist at this receptor complex. By binding and activating IFNAR1 and IFNAR2, peginterferon triggers interferon signaling, which is the basis for its evaluation as a maintenance treatment in multiple myeloma.

Who makes Peginterferon?

Peginterferon is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 3 multiple myeloma maintenance program for this agent. The asset is identified in ChEMBL under the identifier CHEMBL1201560.

What phase is Peginterferon in?

Peginterferon is in Phase 3 development for multiple myeloma. It is an investigational agent and is not approved for this use. The Phase 3 trial in this program has completed, and no trials are currently listed as active for this indication.

What clinical trials is Peginterferon in?

Peginterferon has been evaluated in the Phase 3 trial NCT00732641, titled Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy. That trial enrolled 244 participants, was randomized, used a no-treatment control, and has completed. Participants were 18 years or older.