Characteristics and outcomes of patients from the French temporary authorisation for use (TAU) ceritinib study with other ceritinib data in crizotinib-pretreated patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC)
| French TAU ceritinib study | ASCEND-1 (phase 1) | Gainor cohort | ASCEND-2 (phase 2) | ASCEND-5 (phase 3) | |
| Subjects n | 214 | 163 | 73# | 140 | 115 |
| ECOG % | |||||
| PS 0–1 | 70.8 | 87.1 | NA | 85.7 | 92.2 |
| PS 2–4 | 29.3 | 12.9 | NA | 14.3¶ | 7.8¶ |
| Prior lines % | |||||
| 1 | 7 | 16 | NA | 0 | 0 |
| 2 | 45.5 | 27.6 | NA | 43.6 | 87.8 |
| >2 | 47.4 | 56.0 | NA | 56.4 | 11.3+ |
| Brain metastases % | 51 | 61 | NA | 71 | 56.5 |
| ORR % | 52.4 | 56.4 | NA | 38.6 | 39.1 |
| DCR % | 75.2 | 74.2 | NA | 77.1 | 76.5 |
| Median ceritinib duration/exposure months | 3.9 (all patients) 5.5 (>12 months follow-up, 78% maturity) | ||||
| Median PFS months | NA | 6.9 | 7.8 | 5.7 | 5.4 |
| Median OS months | Not evaluable or not mature | 16.7 | 49.4 (from diagnosis) 30.3 (from crizotinib start) | 14.9 (42% maturity) | 18.1 (∼50% maturity) |
| Dose reduction/interruption % | 32.2 | 62 (reduction) 74 (interruption) | NA | 54.3 | 80.0 |
| Discontinuation due to AEs % | 6.3 | 11 | NA | 7.9 | 5.2 |
ECOG: Eastern Cooperative Oncology Group; PS: performance status; NA: not available; ORR: objective response rate; DCR: disease control rate; PFS: progression-free survival; OS: overall survival; AE: adverse event. #: 71 subjects from ASCEND-1; ¶: PS 2; +: three prior lines of therapy.