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NCT04534205 (BNT113 in Head and Neck Cancer): BVCT ex-ante prediction vs. reported outcome

On 9 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Sep 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (yet weak additive efficacy) and commercially TBD.

Clinical Trial

NCTID
NCT04534205
Acronym
AHEAD-MERIT
Drug Name
BNT113
Drug MoA
HPV16 E6/7 RNA-LPX mRNA vaccine
Drug Modality
mRNA vaccine
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Head and Neck Cancer
Human Patients
285
Sponsor
BioNTech
Phase
Phase 2

Prediction of , index 1733

Prospective Prediction
Prediction Index
1733
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS non-superior to pembrolizumab + chemotherapy as 1L SoC)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS against pembrolizumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
39 days in advance
Readout Data Interpretation
BNT113 + pembrolizumab achieved 40% uORR + 3.9-month mPFS; which is non-superior to 36% ORR + 4.9-month mPFS achieved be chemo + pembrolizumab in KEYNOTE-048 (Lancet DOI- 10.1016/S0140-6736(19)32591-7t).
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (yet weak additive efficacy) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1
Phase
Phase 2, Phase 3
Status
Active not recruiting
Enrollment
358
Lead sponsor
BioNTech SE
Conditions
Unresectable Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer
Interventions
BIOLOGICAL: BNT113; BIOLOGICAL: Pembrolizumab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-01-07
Primary completion
2028-08
Completion
2028-08
Primary outcomes
  • Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab (up to 27 months)
  • Part B - Overall survival (OS) (up to 48 months)
  • Part B - Progression-free survival (PFS) (up to 48 months)

NCT04534205 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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