6 / 39
Real situation in 2019
ALK TKI
Approved
1
st
line
Study
crossover
N RR
(%)
PFS
(mo)
OS
G ≥ 3 AE
(%)
1
st
G
Crizotinib 250 BD FDA/EMA
PROFILE 1014
84
343 74 10.9 NR.4y OS: 57% 50.3
PROFILE 1029
81
207 88 11.1
29
2
nd
G
Ceritinib 750 QD FDA/EMA
ASCEND 4
70
376 73 16.8
NE. 2y OS:
71%
78
Alectinib 600 BD FDA/EMA
ALEX 600 BD
Not allowed 303 83 34.8
NE
45
ALESSIA 600 BD
Not allowed 187 91
NE
NE
29
Alectinib 300 BD
J-ALEX 300 BD
Allowed 207 92 25.9
NR
32
Brigatinib 90/180
ALTA-1L
25
275 71
NR
NE
61
Ensartinib 225QD
EXALT
3
rd
G
Lorlatinib 100 QD
CROWN
PFS by IBCR in Crizotinib, Ceritinib, brigatinib, ALESIA * PFS by investigator in Alectinib,
ALEX: 45% Asian population. ALTA-1L: 39% Asian population
Salomon – JCO 2018 * Wu – JTO 2018 * Soria - Lancet Oncol 2016 * Camidge – ASCO 2018
* Zhou – ESMO 2018 * Takiguchi – asco 2018 * Camidge – NEJM 2018