ESMO 2023 BioNTech Data
BNT211 Demonstrates Encouraging Signs of Activity at Dose Level 2
Phase 1/2 FIH study (NCT04503278): Efficacy at all dose level 2
Haanen J. et al. Presented at ESMO 2023. Abstract #LBA35.
60
30
Change in target sum [%]
60
30
-90
Best response and change in target sum (DL2 only)
ས།།
Change in target sum [%]
60
40
40
20
20
O
-20
-40
-60
-80
-100
0
CLDN6 CAR-T
<DL2 DL2 >DL2 Total
Safety evaluable
patients, n
10
27
7
44
Efficacy evaluable
9
22
7 38
patients, n
Patients with PR/CR, n
1
13
3
17
Patients with SD, n
1
8
2
11
Patients with PD, n
7
1
2
10
ORR, %
50
100
150
200
DCR, %
Days post-infusion
11.1
59.1 42.9
44.7
22.2 95.5 71.4
73.7
GCT EOC Others
Data cut-off: 10 Sep 2023. Waterfall plot showing best percent change from baseline in sum of target lesion diameters and spider plot showing percent change in target sum from baseline over time for patients treated with CLDN6 CAR-T± CLDN6 CARVac at DL2 (N = 22). Patient had non-measurable disease per RECIST
1.1 and BOR was assessed by tumor marker response. ** Patient achieved complete response after surgical removal of tumors. Response data was pending for 5 patients at the data cut-off. Dotted lines show standard response evaluation criteria used to determine objective tumor response for target lesions per RECIST 1.1
(CR -100%, PR = 30 to -100%, SD = -30 to 20%, and PD = 20% or higher). Graphs contains additional data entered manually into the database following the data cut-off date that was not available in formal outputs. BOR = best overall response; CR = complete response; DCR disease control rate; DL = dose level;
EOC epithelial ovarian cancer; GCT = germ cell tumor; PD = progressive disease; ORR = objective response rate; PR = partial response; SD = stable disease.
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