Table 3.
Retrospective analyses of intracranial responses in patients with ALK-rearranged NSCLC with baseline brain metastases and evaluable MRI/CT scans (in all patients and as a function of prior radiotherapy to the brain)
| Efficacy parameter | ALKi-naïve | ALKi-pretreated | ||||
|---|---|---|---|---|---|---|
| Intracranial response in all patients with baseline brain metastases (measurable and non-measurable) by MRI/CT (N=94) | ||||||
| All NSCLC (n=19) |
No prior RT (n=8) |
Prior RT (n=11) |
All NSCLC (n=75) |
No prior RT (n=23) |
Prior RT (n=52) |
|
| Complete response, n | 3 (15·8%) | 1 | 2 | 4 (5·3%) | 2 | 2 |
| Partial response, n | 5 (26·3%) | 3 | 2 | 10 (13·3%) | 3 | 7 |
| Stable disease*, n | 7 (36·8%) | 3 | 4 | 35 (46·7%) | 10 | 25 |
| Progressive disease, n | 0 (0·0%) | 0 | 0 | 12 (16·0%) | 5 | 7 |
| Unknown#, n | 4 (21·1%) | 1 | 3 | 14 (18·7%) | 3 | 11 |
| IDCR, n (%) [95% CI] |
15 (78·9) [54·4–93·9] |
N/A | N/A | 49 (65·3) [53·5–76·0] |
N/A | N/A |
| Intracranial DOR, median [95% CI] (months) |
NE [5·6–NE] |
N/A | N/A | 6·9 [2·9–NE] |
N/A | N/A |
| Intracranial response in patients with measurable baseline brain metastases by MRI/CT (N=36) | ||||||
| All NSCLC (n=8) |
No prior RT (n=4) |
Prior RT (n=4) |
All NSCLC (n=28) |
No prior RT (n=7) |
Prior RT (n=21) |
|
| Complete response (CR), n | 0 (0·0%) | 0 | 0 | 0 (0·0%) | 0 | 0 |
| Partial response (PR), n | 5 (62·5%) | 3 | 2 | 10 (35·7%) | 3 | 7 |
| Stable disease (SD), n | 0 (0·0%) | 0 | 0 | 7 (25·0%) | 1 | 6 |
| Progressive disease (PD), n | 0 (0·0%) | 0 | 0 | 6 (21·4%) | 2 | 4 |
| Unknown, n | 3 (37·5%) | 1 | 2 | 5 (17·9%) | 1 | 4 |
| OIRR (CR+PR), n (%) [95% CI] |
5 (62·5) [24·5–91·5] |
N/A | N/A | 10 (35·7) [18·6–55·9] |
N/A | N/A |
| IDCR (CR+PR+SD), n (%) [95% CI] |
5 (62·5) [24·5–91·5] |
N/A | N/A | 17 (60·7) [40·6–78·5] |
N/A | N/A |
| Intracranial DOR, median [95% CI] (months) |
8·2 [5·6–NE] |
N/A | N/A | 11·1 [2·8–NE] |
N/A | N/A |
ALK=anaplastic lymphoma kinase. CI=confidence interval. CT=computed tomography. DOR=duration of response. IDCR=intracranial disease control rate. MRI=magnetic resonance imaging. N/A=non-applicable. NSCLC=non-small-cell lung cancer. OIRR=overall intracranial response rate. RT=radiotherapy.
Non-CR/non-PD in patients with non-measurable brain lesions at baseline.
A response was listed as unknown if all post-baseline assessments had overall response as unknown (n=5), there was no valid post-baseline assessment (n=1), assessment of PD was considered too late (e.g. no valid assessment before week 12; n=3), or assessment of SD was too early (e.g. assessed before day 42 with no further valid assessment; n=9).