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ARRY-614, p38/Tie2 inhibitor;

Phase 1

Myelodysplastic Syndromes | Small molecule | Hematology |Pfizer, Inc.|Last Updated: Sep 9, 2020

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
UNCONTROLLED
Total Trials2
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01496495A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic SyndromesPHASE1 COMPLETED 71 — — Jan 1, 2012Mar 18, 2015Sep 9, 20204 United States
NCT00916227A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic SyndromePHASE1 COMPLETED 45 — — Jun 1, 2009 -Sep 9, 20203 United States
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Study Endpoints
Primary Endpoints
Establish the maximum tolerated dose (MTD) of study drug.
Part 1, 9 months
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, 9 months; Part 2, 9 months
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Part 1, 9 months; Part 2, 9 months
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Part 1, one year; Part 2, one year
Secondary Endpoints
Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
Part 1, 9 months; Part 2, 9 months
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Part 1, one year; Part 2, one year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-614EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-614, p38/Tie2 inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria (Part 1 and Part 2): * Diagnosis of MDS by bone marrow biopsy. * International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS. * May have received prior therapy for MDS. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2...

Countries:United States
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY10PHASE3Luspatercept, Epoetin Alfa, Epoetin alfa, Azacitidine, BMS-986497
AbbVie, Inc.ABBV3PHASE3Venetoclax, Azacitidine, venetoclax + azacitidine +/- donor lymphocyte infusion
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK4PHASE3Elritercept, Epoetin Alfa, TAK-226
argenx SE Sponsored ADRARGX1PHASE3Empasiprubart, IVIG
Incyte CorporationINCY4PHASE2Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D, Conditioning Regimen E
Novartis AG Sponsored ADRNVS2PHASE2decitabine, spartalizumab, sabatolimab, azacitidine, venetoclax
Geron CorporationGERN3PHASE2Imetelstat, Cytarabine, Fludarabine, Hydrocortisone, Leucovorin Calcium
GSK plc Sponsored ADRGSK1PHASE2Momelotinib
Agios Pharmaceuticals, Inc.AGIO1PHASE2Tebapivat
ICON PlcICLR1PHASE2SP-420
Ascentage Pharma Group International Unsponsored ADRAAPG2PHASE3Lisaftoclax, Azacitidine, APG-115, Cytarabine
Tango Therapeutics, Inc.TNGX2PHASE3Ivosidenib, Azacitidine, AG-120
Johnson & JohnsonJNJ3PHASE1JNJ-89853413, JNJ-75348780, JNJ-67856633, JNJ-54179060, JNJ-64264681
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
TScan Therapeutics, Inc.TCRX2PHASE1Undisclosed
Pfizer Inc.PFE1PHASE1SEA-CD70, azacitidine, Venetoclax
Precigen IncPGEN1PHASE1PRGN-3006 T Cells
AstraZeneca PLCAZN1PHASE1AZD3632, Posaconazole
Foghorn Therapeutics, Inc.FHTX1PHASE1FHD-286, Low Dose Cytarabine, Decitabine
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