BioNTech Results Presentation Deck
BNT311: Phase 2 Trial Targeting CPI-experienced PD-L1+ R/R NSCLC
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Stage IV metastatic R/R
NSCLC (2L+)
PD-L1 TPS ≥1%
20
R
FPD in December 2021 N-130
Primary Endpoints
1:1:1
ORR per RECIST 1.1
Standard of Care Benchmark
2
Docetaxel, ORR: 4-15% ²
A: BNT311 monotherapy
Open-label, randomized Phase 2 trial
BNT311 as monotherapy and in combination with Pembrolizumab after
treatment with SOC immune checkpoint inhibitor
B*: BNT311+ pembrolizumab
C*: BNT311 + pembrolizumab
(alternative treatment schedule)
Secondary Endpoints
• PFS
• DOR
Significant unmet need in R/R NSCLC
~1.8 million lung cancer deaths worldwide annually¹
NSCLC is most common type (~85%) ²
5-year survival only 4% for advanced or metastatic.
NSCLC3
CPI therapy fails in majority of NSCLC patients due to
evolution of resistance
Poor prognosis for CPI R/R NSCLC
Estimated PFS of < 6 months and OS of <1 year
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New strategies needed to overcome
resistance and maximize efficacy
Partnered with Genmab; 50:50 profit/loss collaboration
R/R, refractory/relapsed; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; SOC, Standard of Care; CPI, check point inhibitor;
TPS, tumor proportion score; ORR; objective response rate; PFS, progression free survival; DoR, duration of response; OS, Overall Survival
*Following Safety run-in
¹Bray et al., 2018; 2https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics; Cancer statistics, 2018.Siegel et al., CA Cancer J Clin. 2018 Jan; 68(1):7-30
2Qu et al., 2022; https://journals.sagepub.com/doi/10.1177/1758835921992968
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