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NCT05654623 (Vepdegestrant in ER+HER2- advanced breast cancer): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 11 Mar 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant (PFS) and commercially TBD.

Clinical Trial

NCTID
NCT05654623
Acronym
VERITAC-2
Drug Name
Vepdegestrant
Drug MoA
PROTAC-based ER degrader
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
ER+HER2- advanced breast cancer
Human Patients
624
Sponsor
Arvinas / Pfizer
Phase
Phase 3

Prediction of , index 1423

Prospective Prediction
Prediction Index
1423
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to fulvestrant as 2L treatment)
Technical Prediction
SUCCESS (statistically significant clinical benefit as 2L treatment)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
421 days in advance
Readout Data Interpretation
vepdegestrant met the primary endpoint in PFS (HR < 0.60) for ESR1m population but not the ITT population; OS data not mature
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
tentatively missed prediction for PFS only ; ultimately could still be correct prediction should OS results turn out to be aligned with predictions
Clinical Benefit Conclusion
statistically insignificant (PFS) and commercially TBD
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
Phase
Phase 3
Status
Active not recruiting
Enrollment
624
Lead sponsor
Pfizer
Conditions
Advanced Breast Cancer
Interventions
DRUG: ARV-471; DRUG: Fulvestrant
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-03-03
Primary completion
2025-01-31
Completion
2028-05-15
Results first posted
2026-02-03
Primary outcomes
  • Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants (From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively))
  • PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation (From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively))

NCT05654623 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials