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NCT05111626 (Bemarituzumab in 1L advanced gastric cancer/ GEJ cancer…): BVCT ex-ante prediction vs. reported outcome

On 4 Dec 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 4 Nov 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant (ORR/PFS) and commercially maybe sufficient (OS).

Clinical Trial

NCTID
NCT05111626
Acronym
FORTITUDE-102
Drug Name
Bemarituzumab
Drug MoA
FGFR2B inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L advanced gastric cancer/ GEJ cancer with FGFR2b over expression
Human Patients
515
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 1853

Prospective Prediction
Prediction Index
1853
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in OS superior to nivolumab + chemotherapy)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in ORR/PFS superior to nivolumab + chemotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
335 days in advance
Readout Data Interpretation
bemarituzumab + chemotherapy + nivolumab failed to deliver sufficient efficacy in PFS/ORR and further development has been discontinued
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modeling of drug MoA for ORR/PFS that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant (ORR/PFS) and commercially maybe sufficient (OS)
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
Phase
Phase 3
Status
Terminated
Enrollment
515
Lead sponsor
Amgen
Conditions
Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG: Bemarituzumab; DRUG: Nivolumab; DRUG: Chemotherapy; OTHER: Placebo
Design
Randomized · Sequential · Double
Primary purpose
Treatment
Start
2022-03-14
Primary completion
2025-10-14
Completion
2025-10-29
Primary outcomes
  • Part 1: Number of Participants Who Experienced DLTs (28 days)
  • Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) (Up to 4.5 years)
  • Part 1: Number of Participants Who Experienced One or More Related TEAEs (Up to 4.5 years)
  • Part 1: Number of Participants With Clinically Significant Changes in Vital Signs (Up to 4.5 years)
  • Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity (Up to 4.5 years)

NCT05111626 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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