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NCT05546476 (ponsegromab in Cancer Cachexia): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 14 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05546476
Acronym
PROACC-1
Drug Name
ponsegromab
Drug MoA
anti-GDF15 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Cancer Cachexia
Human Patients
187
Sponsor
Pfizer
Phase
Phase 2

Prediction of , index 1416

Prospective Prediction
Prediction Index
1416
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
243 days in advance
Readout Data Interpretation
ponsegromab exhibited non-positive dose-response relationship and failed to meet key secondary/exploratory endpoints (at most 4-point increase in FAACT-ACS; at most 2-point increase in FAACT-5IASS; CRCSD; physical activity; gait endpoints).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
Phase
Phase 2
Status
Completed
Enrollment
187
Lead sponsor
Pfizer
Conditions
Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Loss of Appetite; Fatigue; Cachexia
Interventions
DRUG: ponsegromab; DRUG: Placebo for ponsegromab
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-11-21
Primary completion
2024-03-13
Completion
2025-04-23
Results first posted
2025-04-29
Primary outcomes
  • Part A: Change From Baseline in Body Weight at Week 12 (Baseline, Week 12)

NCT05546476 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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