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BMS-986158

Phase 1

Myelofibrosis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 8, 2026

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment216
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04817007A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)PHASE1 ACTIVE NOT_RECRUITING 216 — — Mar 22, 2021Aug 31, 2028May 8, 202649 United States, Australia +9
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Up to 52 months
Incidence of serious adverse events (SAEs)
Up to 52 months
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to 26 months
Incidence of AEs leading to discontinuation
Up to 52 months
Incidence of death
Up to 52 months
Secondary Endpoints
Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Up to 175 days
Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Up to 175 days
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Up to 175 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 1B: BMS-986158 + FedratinibEXPERIMENTAL -
Part 2A1: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 2B1: BMS-986158 + FedratinibEXPERIMENTAL -
Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicableEXPERIMENTAL -
Part 2A2 Add-On: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 2A3: BMS-986158 + RuxolitinibEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986158DRUGSpecified dose on specified days
RuxolitinibDRUGSpecified dose on specified days
FedratinibDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis * Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment ...

Countries:United StatesAustraliaFranceGermanyGreeceIsraelItalyPolandRomaniaSouth KoreaSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04817007primaryCompletionDate: changed
LOWMay 24, 2026NCT04817007studyFirstPostDate: changed