WHY results are SO different??
Rizvi, et al. ESMO 2016
2. Clinical Trial design differences
KN024
CM026
Tumor biopsy
After metastatic diagnosis
Within 6 months
PD-L1 cut-off
50% (22C3 clone)
5% (28-8 clone)
Prevalence
30%
50%
Imaging Interval
Q9 weeks
Q6 weeks
Primary endpoint
PFS (RECIST)
PFS (IRRC)
Never smokers
3%
11%
Squamous histology
19%
24%
PFS CT comparator
6.0 months
5.9 months
ORR (50% cut-off)
45%
34%
Exposure
7 months
3.7 months
Grade 3-4 toxicity
7%
9,7%
