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NCT05338970 (Patritumab Deruxtecan in advanced NSCLC): BVCT ex-ante prediction vs. reported outcome

On 9 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. 2 readouts followed: 24 Sep 2024, True Negative (TN); 29 May 2025, True Negative (TN).

Clinical Trial

Acronym
HERTHENA-Lung02
Drug Name
Patritumab Deruxtecan
Drug MoA
anti-HER3 ADC conjugated with a TOP1 inhibitor payload
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced NSCLC
Human Patients
586
Sponsor
Daiichi Sankyo Company / Merck & Co.
Phase
Phase 3

Prediction of , index 1782

Prospective Prediction
Prediction Index
1782
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS inferior to chemotherapy yet numerically superior to BL-B01D1)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ORR/PFS numerically superior to chemotherapy yet numerically inferior to BL-B01D1); partial FAILURE (statistically insignificant clinical benefit in tolerability inferior to chemotherapy yet numerically superior to BL-B01D1)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
15 days in advance
Readout Data Interpretation
statistically significant improvement in PFS over the SoC chemotherapy (without disclosure of the specific data and p-value; indicating probably weak efficacy in PFS).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably weakly significant (in PFS) and commercially TBD (OS data not mature)
Prediction Classification
True Negative (TN)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
262 days in advance
Readout Data Interpretation
patritumab deruxtecan failed to achieve statistically significant clinical benefit in OS compared with the SoC chemotherapy; and achieved 5.8 months mPFS; slightly superior to 5.6 months mPFS achieved by the SoC chemotherapy (HR = 0.77; P=0.011) (see add'l link below); BLA voluntarily withdrawn
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak efficacy (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 Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)
Phase
Phase 3
Status
Active not recruiting
Enrollment
586
Lead sponsor
Daiichi Sankyo
Conditions
Nonsquamous Non-small Cell Lung Cancer; EGFR L858R; EGFR Exon 19 Deletion
Interventions
DRUG: Patritumab Deruxtecan; DRUG: Platinum-based chemotherapy
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-07-08
Primary completion
2024-05-31
Completion
2026-12-31
Primary outcomes
  • Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1 (Baseline up to approximately 49 months)

NCT05338970 on ClinicalTrials.gov

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