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MEDI4736

Phase 1

Solid Tumors | Small molecule | Oncology |Incyte Corporation|Last Updated: Jan 13, 2022

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 Enrollment176
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02318277A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)PHASE1 COMPLETED 176 — — Jan 5, 2015Oct 16, 2020Jan 13, 202213 United States
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Study Endpoints
Primary Endpoints
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured every 8 weeks for duration of study treatment [approximately 12 months]

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Endpoints
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
Measured every 8 weeks for duration of study treatment [approximately 6 months]
Phase 2: Number of Treatment-Emergent Adverse Events
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI4736 + INCB024360EXPERIMENTALMEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
Interventions
NameTypeDescription
MEDI4736DRUGMEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360DRUGINCB024360: Oral daily dosing
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Male or female subjects, age 18 years or older * Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors * Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to tre...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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