Q3 2020 Sales Performance
ORR (%)
bintrafusp alfa (M7824)*
Encouraging clinical efficacy, pivotal study started in BTC
Non small cell lung cancer (NSCLC) 2L
Pembrolizumab response rates in KEYNOTE
010 and KEYNOTE 001 studies in 2L NSCLC
100%
80%
60%
44%
40%
18%
27%
18%
29%
20%
0%
All
PD-L1+*
PD-L1 high*
■Keynote 010 Keynote 001
bintrafusp alfa response rates in 2L NSCLC
1200mg
(data cut off 23 July 2018)
ORR (%)
100%
80%
86%
(6/7)
60%
37%
40%
25%
(10/27)
20%
(10/40)
0%
All
PD-L1+* PD-L1 high*
• Durable responses across all PD-L1 expression
levels in 2L NSCLC
Efficacy according to independent read, RECIST 1.1
gsk
Biliary tract cancer (BTC) 2L
B
Minor, peripheral
Significant
biliary duct
duation...
..bifurcation
biliary duet
dilation
Extra-
hepatio
tumor
Intra
hepatic
tumor
Change in Sum of Diameters (%)
• Overall Response Rate (ORR) of 20%
• Median Overall Survival (mOS) of 12.7 months
• Benchmark
2L Chemotherapy: 5-8% ORR and 7.2 months mOS#
Pembrolizumab: 5.8% ORR and 9.1 months mOS (Keynote-158)^
* PD-L1+ (pembro:22C3 TPS ≥1%; M7824: EMD001 ≥1%), PD-L1 high (pembro:22C3 TPS ≥ 50%; M7824: EMD 001 ≥ 80%; TPS ≥50% with 22C3 comparable to ≥80% with EMD 001 assessments)
+ Alliance with Merck KGaA, Darmstadt, Germany; # Salati et al., ASCO 2019; ^ Ueno et al., ESMO 2018
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