BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

BNT111: Global Phase 2 Clinical Trial in Anti-PD1 R/R Melanoma Patients 25 BNT111-01 Patients with anti-PD1-R/R, unresectable Stage III or IV melanoma ● 2:1:1 ● R n=120 BNT111 + cem iplim ab ≤ 24 months n=60 n=30 n=30 BNT111 ≤ 24 months Addition of cemiplimab upon disease progression Cemiplimab ≤ 24 months Open-label, randomized Phase 2 trial BNT111 and cemiplimab in combination or as single agents Collaboration with Regeneron Addition of BNT111 upon disease progression Success Measures for BNT111 Trial ORR 30% 000 0 0 0 OS Follow-up every 3 months for ≤ 48 months from first dose Primary Endpoints ● Secondary Endpoints ORR (key secondary endpoint arms 2, 3) DOR, DCR, TTR, PFS by RECIST 1.1 OS, safety, tolerability, PRO ● Arm 1: ORR by RECIST 1.1 ● PD1, Programmed cell death protein 1; R/R, refractory/relapsed; ORR, overall response rate; DoR, Duration of Response; DCR, disease control rate; TTR, time to response; PFS, progression free survival; OS, overall survival; PRO, patient reported outcomes https://clinical trials.gov/ct2/show/record/NCT04526899 BIONTECH
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