BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04811027 (Eftilagimod alpha in Recurrent or Metastatic HNSCC): BVCT ex-ante prediction vs. reported outcome

On 4 Sep 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. 2 readouts followed: 12 Jul 2024, True Positive (TP); 5 May 2025, True Positive (TP).

Clinical Trial

NCTID
NCT04811027
Acronym
TACTI-003
Drug Name
Eftilagimod alpha
Drug MoA
a Soluble LAG-3 Fusion Protein
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Recurrent or Metastatic HNSCC
Human Patients
171
Sponsor
Immutep
Phase
Phase 2

Prediction of , index 1240

Prospective Prediction
Prediction Index
1240
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
312 days in advance
Readout Data Interpretation
35.5% ORR vs 30.8% ORR for chemo+pembrolizumab in CPS <1 population (Burtness et al. 2022 J. Clin Oncol).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior to SoC ORR) and commercially TBD (OS data pending)
Prediction Classification
True Positive (TP)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
609 days in advance
Readout Data Interpretation
efti + pembrolizumab achieved 17.6 months mOS; superior to 10.7 months mOS achieved by cetuximab + chemotherapy or 11.3 months mOS achieved by anti-PD1 therapy + chemotherapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
TACTI-003 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Randomized, Phase II Trial to Investigate a Soluble LAG-3 Fusion Protein, Eftilagimod Alpha (Efti; IMP321) in Combination With Pembrolizumab (PD-1 Antagonist) for First Line Treatment of Subjects With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Phase
Phase 2
Status
Completed
Enrollment
171
Lead sponsor
Immutep S.A.S.
Conditions
HNSCC
Interventions
DRUG: eftilagimod alpha; DRUG: pembrolizumab (KEYTRUDA®)
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-08-27
Primary completion
2024-03-11
Completion
2025-11-05
Primary outcomes
  • Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Up to 24 months)

NCT04811027 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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