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Blinatumomab

Phase 1

Philadelphia Chromosome-Positive | Small molecule | Oncology |Novartis AG|Last Updated: May 15, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06308588Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic LeukemiaPHASE1 RECRUITING 40Aug 5, 2024May 1, 2029May 15, 20262 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
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Blinatumomab + AsciminibEXPERIMENTALParticipants found to be eligible to take part in this study will receive 5 cycles of blinatumomab and asciminib, followed by asciminib alone for as long as it benefits the participant. Participants will receive blinatumomab as a continuous (non-stop) infusion on Days 4-31 of Cycle 1 and on Days 1-28 of Cycles 2-5. Participants will take asciminib by mouth 2 times every day during this study.
Interventions
NameTypeDescription
BlinatumomabDRUGGiven by Infusion
AsciminibDRUGGiven by PO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Diagnosis of one of the following: a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06308588studyFirstPostDate: changed