28 / 49
Response
CNS full analysis set (n=128)
CNS evaluable for response set (n=41)
Osimertinib
(n=61)
SoC
(n=67)
Osimertinib
(n=22)
SoC
(n=19)
CNS ORR, (95% CI)
66% (52, 77)
43% (31, 56)
91% (71, 99)
68% (43, 87)
Odds ratio
#
(95% CI); p-value
ǂ
2.5 (1.2, 5.2); p=0.011
4.6 (0.9, 34.9); p=0.066
Complete response, n (%)
25 (41)
16 (24)
5 (23)
0
Partial response, n (%)
15 (25)
13 (19)
15 (68)
13 (68)
Stable disease ≥6 weeks, n (%)
15 (25)
27 (40)
1 (5)
4 (21)
Median time to response, weeks
6.2
11.9
6.0
6.3
CNS DCR
§
,
(95% CI)
90% (80, 96)
84% (73, 92)
95% (77, 100)
89% (67, 99)
Odds ratio
#
(95% CI); p-value
ǂ
1.8 (0.6, 5.5); p=0.269
2.5 (0.2, 55.8); p=0.462
♦
Good concordance observed between CNS ORR and systemic ORR for the CNS full analysis and evaluable for
response sets
♦
Analysis of CNS ORR was repeated for confirmed CNS responses
¶
, results were consistent with the unconfirmed CNS
ORR
CNS RESPONSE*
Presented by J Vansteenkiste at ESMO Asia 2017, 17–19 November 2017, Singapore
Proferred Paper Session 1, Abstract LBA5. Ann Oncol 2017;28 (suppl_10): mdx729.007