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IPH2102 at /kg

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Innate Pharma S.A.|Last Updated: Feb 8, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01687387Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)PHASE2 COMPLETED 152Oct 1, 2012Nov 17, 2016Feb 8, 201943 France
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Study Endpoints
Primary Endpoints
Leukemia-Free Survival
from date of randomization until the date of first documented relapse, assessed up to 48 months
Secondary Endpoints
Number of Participants With Adverse Events
from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IPH2102 at 1 mg/kgEXPERIMENTALlirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 0.1 mg/kgEXPERIMENTALlirilumab (IPH2102/BMS986015) at 0.1 mg/kg
Placebo (Normal saline solution)PLACEBO_COMPARATORNormal saline solution
Interventions
NameTypeDescription
IPH2102 at 0.1 mg/kgDRUGevery 3 months
IPH2102 at 1 mg/kgDRUGevery 4 weeks
Placebo (normal saline solution)DRUGevery 4 weeks
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Eligibility Criteria
Age Range60 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: 1. Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Stand...

Countries:France
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