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PF-08634404

Phase 3

Endometrial Neoplasms | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: Jun 4, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07578649Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial CancerPHASE3 NOT YET_RECRUITING 600Oct 9, 2026Jan 30, 2031Jun 4, 20264 United States
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS) using RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)
Approximately 36 months

PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by BICR, or death due to any cause, whichever occurs first.

Secondary Endpoints
Overall Survival (OS)
Approximately 56 months
PFS using RECIST v1.1 as assessed by investigator
Approximately 36 months
Objective Response Rate (ORR) as assessed by BICR and investigator
Approximately 56 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-08634404 plus ChemotherapyEXPERIMENTALPF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
Pembrolizumab plus ChemotherapyACTIVE_COMPARATORPembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
Interventions
NameTypeDescription
PF-08634404BIOLOGICALSolution for IV infusion
PembrolizumabBIOLOGICALSolution for IV infusion
Standard of Care ChemotherapyDRUGSolution for IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Women ≥18 years of age who are confirmed not pregnant at screening. * Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded. * Newly diagnosed FIGO Stage III disease with measurab...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07578649lastUpdatePostDate: changed
LOWJun 4, 2026NCT07578649lastUpdatePostDate: changed
LOWJun 4, 2026NCT07578649lastUpdatePostDate: changed
LOWJun 4, 2026NCT07578649lastUpdatePostDate: changed
LOWMay 24, 2026NCT07578649studyFirstPostDate: changed
LOWMay 21, 2026NCT07578649NEW_TRIAL: changed
LOWMay 21, 2026NCT07578649NEW_TRIAL: changed