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NCT05499390 (Ivonescimab in Advanced Non-small-cell Lung Cancer): BVCT ex-ante prediction vs. reported outcome

On 9 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (superior).

Clinical Trial

NCTID
NCT05499390
Acronym
HARMONi-2
Drug Name
Ivonescimab (AK112)
Drug MoA
anti-PD-1 and anti-VEGF tetravalent bsAb
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Non-small-cell Lung Cancer
Human Patients
398
Sponsor
Summit Therapeutics
Phase
Phase 3

Prediction of , index 1666

Prospective Prediction
Prediction Index
1666
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS superior to pembrolizumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS superior to pembrolizumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
61 days in advance
Readout Data Interpretation
Median PFS of 11.14 Months vs. 5.82 Months by pembrolizumab and serious TRAEs were 20.8% vs. 16.1%; respectively; in ivonescimab and pembrolizumab arms.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (superior)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized Controlled, Multi-center Phase III Clinical Trial of AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
Phase
Phase 3
Status
Active not recruiting
Enrollment
398
Lead sponsor
Akeso
Conditions
Advanced Non-small-cell Lung Cancer
Interventions
DRUG: AK112; DRUG: Pembrolizumab
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-11-09
Primary completion
2024-01-29
Completion
2026-12-31
Primary outcomes
  • PFS assessed by IRRC per RECIST v1.1 (Up to 2 approximately years)

NCT05499390 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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