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 studyASCEND-1 (phase 1)Gainor cohortASCEND-2 (phase 2)ASCEND-5 (phase 3)
Subjects n21416373#140115
 PS 0–170.887.1NA85.792.2
 PS 2–429.312.9NA14.37.8
Prior lines %
Brain metastases %5161NA7156.5
ORR %52.456.4NA38.639.1
DCR %75.274.2NA77.176.5
Median ceritinib duration/exposure months3.9 (all patients)
5.5 (>12  months follow-up, 78% maturity)
Median PFS monthsNA6.
Median OS monthsNot evaluable or not mature16.749.4 (from diagnosis)
30.3 (from crizotinib start)
14.9 (42% maturity)18.1 (∼50% maturity)
Dose reduction/interruption %32.262 (reduction)
74 (interruption)
Discontinuation due to AEs %6.311NA7.95.2

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.