BioNTech Results Presentation Deck
BNT311: Phase 1 / 2a - Anti-tumor activity in immune checkpoint
recurrent/refractory NSCLC Expansion
A
Best relative change in SoD
from baseline (%)
50
20
25-
ā
0
-25
-50-
-100
PD-L1 TPS, %:
BOR to prior ICI:
-75-
15
PR
-IPP
Best change from baseline in tumor size
FB---PD-
PR PD
NA
PD
SD* SD SD* SD*
45 85
PR PR PD
NE UPR PR*
PR*
NA 10
PD NA SD
80 NA NA
PD NE
B
Change in SoD from baseline (%)
50
25
0
-25-
-50-
-75-
-100
3
Target lesion SoD change from baseline
9
12
Study week
15
18
BOR
PD
SD
PR
Time point
response
PD
SD
PR
NA
As of October 12, 2020, 24 patients were enrolled in expansion cohort 1, which includes patients with NSCLC with progression on or after
ICI therapy
21
12 patients had post-baseline scans; 6 patients were still on treatment with BNT311/GEN1046, 6 patients discontinued.
Preliminary efficacy in 12 patients who could be objectively assessed showed two patients who achieved confirmed PR, one with
unconfirmed PR, and four patients with SD
Data cut-off: October 12, 2020.
*Denotes patients with ongoing treatment.
aPR was not confirmed by a subsequent scan.
Includes all patients who had at least one post-baseline tumor assessment (schedule is every 6 weeks), and thus could be assessed for clinical benefit; 6 of 12 patients are still on treatment.
BOR, best overall response; ICI, immune checkpoint inhibitor; NA, not available, NE, non-evaluable; NSCLC, non-small cell lung cancer; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response;
RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SoD, sum of diameters; TPS, tumor proportion score; uPR, unconfirmed partial response.
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