BioNTech Results Presentation Deck
BNT113: First Patient Dosed in Potentially Registrational Phase 2 Trial in
HPV16+ and PD-L1+ HNSCC
BNT113
Unresectable,
recurrent or
metastatic HPV16+
HNSCC, PD-L1+
(CPS ≥1)
29
n ≤ 285
●
Part A: Safety Run-in
BNT113 +
pembrolizumab
n = 12-18
≤ 24 months
●
SRC decision on safety and
RP2DR to start Part B based on
safety in Part A after one
complete cycle
Primary Endpoints
Part A: Emergence of TEAES
Part B: OS, ORR
Part B: Randomization
●
1:1
n = 267
Open-label, controlled, Phase 2 study
BNT113 in combination with pembrolizumab as frontline treatment for metastatic HPV 16+ and PD-L1+ HNSCC
• HPV 16 companion diagnostic is being co-developed and will be clinically validated alongside the trial
Secondary Endpoints
PFS, DCR, DOR
●
>
Safety
Patient reported outcomes
Part B
BNT113 + pembrolizumab
≤ 24 months
Pembrolizumab monotherapy
≤24 months
Success Measures for BNT113 Trial
• mOS: 18 months (HR=0.667)
• ORR: 40%
HPV, human papilloma virus; PD-L1, programmed death-ligand 1; CPS, Combined positive score; HNSCC, head and neck squamous cell carcinoma; SRC, safety review committee; TEAEs, treatment
emergent adverse events; OS, overall survival; mOS, median overall survival; ORR, overall response rate; HR, hazard ratio; DOR, duration of response; DCR, disease control rate; PFS, progression free
survival
¹Burtness, et al. Lancet 2019 Nov 23; 394(10212):1915-28
https://www.clinical trials.gov/ct2/show/NCT04534205
BIONTECHView entire presentation