Table 2.

Investigator-assessed whole-body responses for all patients with ALK-rearranged NSCLC receiving ceritinib 750 mg/day (N=246)

Efficacy parameter	ALKi-naïve (n=83)	ALKi-pretreated (n=163)
Whole-body responses
Complete response, n (%)	1 (1·2)	3 (1·8)
Partial response, n (%)	59 (71·1)	89 (54·6)
Stable disease, n (%)	14 (16·9)	29 (17·8)
Progressive disease, n (%)	0	16 (9·8)
Unknown, n (%)	9 (10·8)	26 (16·0)
Overall response rate, n (%) [95% CI]	60 (72·3) [61·4–81·6]	92 (56·4) [48·5–64·2]
DOR, median [95% CI] (months)	17·0 [11·3–NE]	8·3 [6·8–9·7]
12-month DOR, %	64·3 [48·7–76·3]	25·6 [ 16·0–36·3]
PFS, median [95% CI] (months)	18·4 [11·1–NE]	6·9 [5·6–8·7]
12-month PFS, %	62·3 [50·0–72·4]	27·2 [19·8–35·1]
OS, median [95% CI] (months)	NE [19·61-NE]	16·7 [14·8–NE]
12-month OS, %	83·0 [72·4–89·8]	67·2 [58·9–74·1]

ALK=anaplastic lymphoma kinase. DOR=duration of response. NSCLC=non-small-cell lung cancer. OS=overall survival. PFS=progression-free survival.