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NCT04401748 (Venetoclax in 1L higher-risk myelodysplastic syndrome): BVCT ex-ante prediction vs. reported outcome

On 24 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Jun 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04401748
Acronym
Verona
Drug Name
Venetoclax
Drug MoA
BCL2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L higher-risk myelodysplastic syndrome (HR-MDS)
Human Patients
531
Sponsor
AbbVie
Phase
Phase 3

Prediction of , index 1623

Prospective Prediction
Prediction Index
1623
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in CR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
112 days in advance
Readout Data Interpretation
venetoclax + azacitidine failed to meet the primary endpoint of OS (HR = 0.908 p = 0.3772) compared with azacitidine alone
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of venetoclax’s MoA for 1L HR-MDS that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
Phase
Phase 3
Status
Active not recruiting
Enrollment
531
Lead sponsor
AbbVie
Conditions
Myelodysplastic Syndrome (MDS)
Interventions
DRUG: Venetoclax; DRUG: Azacitidine; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-09-10
Primary completion
2027-07
Completion
2027-07
Primary outcomes
  • Overall survival (OS) (Up To 5 Years)

NCT04401748 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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