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Revumenib

Phase 1

Blinatumomab | Small molecule | Oncology |Amgen Inc.|Last Updated: May 5, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07283640A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic LeukemiaPHASE1 NOT YET_RECRUITING 20May 18, 2026Aug 31, 2031May 5, 20261 United States
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Study Endpoints
Primary Endpoints
Safety and adverse events (AEs).
Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALTreatment with SC Blinatumomab + Revumenib in R/R ALL
Cohort 2EXPERIMENTALTreatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL
Interventions
NameTypeDescription
RevumenibDRUGGiven by po
BlinatumomabDRUGGiven by IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Eligibility Criteria • The following groups of participants will be eligible: * Participants \> 18 years of age with relapsed and/or refractory (defined as \>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or * Participants \>18 years of age with persistent measurable residual...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07283640studyFirstPostDate: changed