Recent Updates
Recently added Catalysts

Vepugratinib

Phase 3

Carcinoma, Transitional Cell | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment450
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07218380A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary TractPHASE3 RECRUITING 450 — — Dec 12, 2025May 1, 2033Jun 3, 2026284 United States, Australia +17
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumab
From baseline up to 90 months
Safety Lead-in: Overall Response Rate (ORR)
From baseline up to 90 months

ORR by Investigator Assessment.

Progression-free Survival (PFS)
Baseline to Study Completion (estimated as 6 years)

PFS by blinded independent committee review (BICR).

Secondary Endpoints
Safety Lead-in: Disease Control Rate (DCR)
From baseline up to the end of Cycle 2 (each Cycle is 21 days)
Safety Lead-in: Time to Response (TTR)
From baseline up to 90 months
Overall Survival (OS)
Baseline to Study Completion (estimated as 6 years)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Vepugratinib + EV + Pembrolizumab (Safety Lead In)EXPERIMENTALVepugratinib administered orally with EV + pembrolizumab administered IV
Vepugratinib + Enfortumab Vedotin (EV) + PembrolizumabEXPERIMENTALVepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
Placebo + EV + PembrolizumabPLACEBO_COMPARATORPlacebo administered orally, and EV + pembrolizumab administered by IV infusion.
Interventions
NameTypeDescription
VepugratinibDRUGAdministered orally
PlaceboOTHERAdministered orally
EVDRUGAdministered by IV infusion
PembrolizumabDRUGAdministered by IV infusion
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites284

Inclusion Criteria: * Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present. * Have a qualifying fibroblast growth facto...

Countries:United StatesAustraliaBrazilCanadaChinaCzechiaDenmarkFranceGermanyHungaryItalyJapanNetherlandsPolandSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07218380lastUpdatePostDate: changed
LOWJun 3, 2026NCT07218380lastUpdatePostDate: changed
LOWMay 26, 2026NCT07218380primaryCompletionDate: changed
LOWMay 24, 2026NCT07218380studyFirstPostDate: changed