Table 3.
Overall and intracranial responses by independent central review among Japanese and all patients (ITT analysis set)
| Japanese patients | All patients | ||||
|---|---|---|---|---|---|
| Prior crizotinib ± CT (EXP2‐3A) | Prior non–crizotinib ALK TKI ± CT (EXP3B) | ≥2 prior ALK TKIs a ± CT (EXP4‐5) | ≥1 prior ALK TKI ± CT (EXP2‐5) | ≥1 prior ALK TKI ± CT (EXP2‐5) | |
| Overall responses | |||||
| Number of patients | 7 | 7 | 17 | 31 | 198 |
| Best overall response | |||||
| Complete response b | 0 | 1 (14.3) | 1 (5.9) | 2 (6.5) | 4 (2.0) |
| Partial response b | 6 (85.7) | 2 (28.6) | 7 (41.2) | 15 (48.4) | 95 (48.0) |
| Stable disease | 1 (14.3) | 3 (42.9) | 6 (35.3) | 10 (32.3) | 53 (26.8) |
| Objective progression | 0 | 1 (14.3) | 3 (17.6) | 4 (12.9) | 32 (16.2) |
| Indeterminate | 0 | 0 | 0 | 0 | 14 (7.1) |
| Confirmed ORR (%; 95% CI) c | 6 (85.7; 42.1‐99.6) | 3 (42.9; 9.9‐81.6) | 8 (47.1; 23.0‐72.2) | 17 (54.8; 36.0‐72.7) | 99 (50.0; 42.8‐57.2) |
| Median duration of response, months (95% CI) d | NR (NE–NE) | NR (NE–NE) | 9.9 (4.2–NE) | NR (9.9–NE) | 11.1 (6.9–NE) |
| Intracranial responses | |||||
| Number of patients e | 3 | 0 | 12 | 15 | 131 |
| Best overall IC response | |||||
| Complete response b | 2 (66.7) | NA f | 4 (33.3) | 6 (40.0) | 37 (28.2) |
| Partial response b | 0 | NA f | 1 (8.3) | 1 (6.7) | 34 (26.0) |
| Stable disease | 1 (33.3) | NA f | 6 (50.0) | 7 (46.7) | 39 (29.8) |
| Objective progression | 0 | NA f | 1 (8.3) | 1 (6.7) | 10 (7.6) |
| Indeterminate | 0 | NA f | 0 | 0 | 11 (8.4) |
| Confirmed IC ORR (%; 95% CI) c | 2 (66.7; 9.4‐99.2) | NA f | 5 (41.7; 15.2‐72.3) | 7 (46.7; 21.3‐73.4) | 71 (54.2; 45.3‐62.9) |
| Median duration of IC response, months (95% CI) d | NR (NE–NE) | NA f | 15.0 (6.9–NE) | NR (15.0–NE) | 19.5 (14.5–NE) |
Data are n (%) unless specified otherwise.
Abbreviations: ALK, anaplastic lymphoma kinase; CI, confidence interval; CT, chemotherapy; EXP, expansion cohort; IC, intracranial; ITT, intention‐to‐treat; NE, not estimable; NR, not reached; ORR, objective response rate; TKI, tyrosine kinase inhibitor.
Lines of therapy (if the same TKI was given twice, this was counted as two prior lines of treatment).
Confirmed response
Using exact method based on binomial distribution.
Kaplan‐Meier estimated median with 95% CI calculated using the Brookmeyer and Crowley method.
Number of patients with ≥1 measurable central nervous system lesion at baseline.
No patient met the reporting criteria.