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Velzatinib

Phase 3

Gastrointestinal Stromal Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: May 13, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07585266A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)PHASE3 NOT YET_RECRUITING 800Jun 15, 2026Sep 28, 2032May 13, 2026 -
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR)
Up to approximately 74 months

PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.

Secondary Endpoints
Confirmed Objective Response Rate (ORR) as assessed by BICR
Up to approximately 75 months
Overall survival (OS)
Up to approximately 75 months
Confirmed ORR as assessed by Investigator assessment
Up to approximately 75 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VelzatinibEXPERIMENTAL -
ImatinibEXPERIMENTAL -
Interventions
NameTypeDescription
VelzatinibDRUGVelzatinib will be administered
ImatinibDRUGImatinib will be administered
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF). * Has histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Has ...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07585266studyFirstPostDate: changed
LOWMay 21, 2026NCT07585266NEW_TRIAL: changed
LOWMay 21, 2026NCT07585266NEW_TRIAL: changed