BioNTech Results Presentation Deck slide image

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 BIONTECH
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