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
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Arm 1: ORR by RECIST 1.1
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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
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