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NCT06396065 (Ivonescimab in 2L advanced EGFR-mutant NSCLC): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 30 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (PFS) and commercially insufficient (non-superior OS).

Clinical Trial

NCTID
NCT06396065
Acronym
HARMONi
Drug Name
Ivonescimab
Drug MoA
anti-PD-1 and anti-VEGF
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
2L advanced EGFR-mutant NSCLC
Human Patients
420
Sponsor
Summit Therapeutics
Phase
Phase 3

Prediction of , index 1667

Prospective Prediction
Prediction Index
1667
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate additive clinical benefit in OS numerically superior to carboplatin + pemetrexed combotherapy)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS non-superior to carboplatin + pemetrexed combotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
294 days in advance
Readout Data Interpretation
ivonescimab + chemotherapy achieved statistically significant clinical benefit in PFS compared with the SoC chemotherapy (HR=0.52; p<0.0001); yet failed to achieve statistically significant clinical benefit in OS compared with the SoC chemotherapy (HR=0.79 p=0.057)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (PFS) and commercially insufficient (non-superior OS)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Phase
Phase 3
Status
Active not recruiting
Enrollment
420
Lead sponsor
Summit Therapeutics
Conditions
Non-Squamous Non-small Cell Lung Cancer
Interventions
DRUG: AK112 Injection; DRUG: Placebo Injection
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-04
Primary completion
2025-04-12
Completion
2026-12-31
Primary outcomes
  • Progression-free survival (PFS) (Up to 2 years)
  • Overall Survival (OS) in the ITT population (Up to 2 years)

NCT06396065 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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