a
at baseline.
1. Brahmer J, et al. New Engl J Med. 2015;373:123–135. 2. Spigel DR, et al. Presented at ASCO 2015, Abstract 8009. 3. Paz-Ares L, et al.
Presented at ASCO 2015, Abstract LBA109.
PD-L1 expression and outcome in nivolumab phase 3 trials
PD-L1
expression
OS
≥1%
<1%
≥5%
<5%
≥10%
<10%
NQ
a
PFS
≥1%
<1%
≥5%
<5%
≥10%
<10%
NQ
a
Squamous NSCLC (CheckMate 017)
1,2
NOT PREDICTIVE
Unstratified HR
Interaction
P
-value
0.69
0.56
0.58
0.53
0.47
0.70
0.50
0.41
0.70
0.39
0.67
0.70
0.66
0.54
0.16
0.75
0.58
0.35
0.70
0.45
Non-squamous NSCLC (CheckMate 057)
3
PREDICTIVE
PD-L1-positive expression
NQ
PD-L1-negative expression
0.25
1.0
2.0
Nivolumab
Docetaxel
0.5
0.125
1.0
0.5
2.0
0.25
Nivolumab
Docetaxel
Unstratified HR
Interaction
P
-value
0.59
0.0646
0.90
0.43
0.0004
1.01
0.40
0.0002
1.00
0.91
0.70
0.0227
1.19
0.54
<0.0001
1.31
0.52
0.0002
1.24
1.06
•
Does mutational burden make a difference?
•
Immune system and squamous versus glandular epithelia?
•
Differences in the patient’s immune status?
•
Different immune infiltrates in and around the tumors?
•
Different immunomodulatory mechanisms?
Beyond the histology