Summary of phase III studies of
immunotherapy in previously treated patients
*850 in primary population
NR = not reached
1. Brahmer, et al. N Engl J Med 2015; 2. Barlesi, et al. ESMO 2016;
3. Borghaei, et al. N Engl J Med 2015; 4. Herbst, et al. Lancet 2015; 5. Herbst, et al. ESMO 2016; 6. Barlesi, et al. ESMO 2016
CheckMate 017
1,2
Nivolumab
vs docetaxel
CheckMate 057
2,3
Nivolumab
vs docetaxel
KEYNOTE-010
4,5
Pembrolizumab (2mg/kg or
10mg/kg) vs docetaxel
OAK
6
Atezolizumab
vs docetaxel
Phase of study
III
III
II/III
III
PD-L1 selected
No
No
Yes (TPS* ≥1%)
No
Study size, n
272
(135 vs 137)
582
(292 vs 290)
1,033
(344 vs 346 vs 343)
1,225
(425 vs 425)*
Histology
Squamous
Non-squamous
All-comers
All-comers
Line of therapy, %
2L
3L
>3L
Other/unknown
100
0
0
0
88
11
<1
0
69
20
9
<1
75
25
0
0
Subsequent CIT
(immunotherapy arm vs
chemo arm), %
2 vs 4
1 vs 4
0.6 vs 1.7 vs 13.1
4.5 vs 17.2
Crossover from chemo arm
to study immunotherapy, %
4
6
Not permitted
Not permitted
Median OS, months
HR vs docetaxel (p value)
9.2 vs 6.0
0.62
12.2 vs 9.5
0.75
10.5 vs 13.6 vs 8.6
2mg/kg: 0.72 (p=0.0003)
10mg/kg: 0.60 (p<0.00001)
13.8 vs 9.6
0.73 (p=0.0003)
