ALEX
Trial question
Is alectinib superior to crizotinib in patients with untreated ALK-positive non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 303
303 patients (171 female, 132 male)
Inclusion criteria: patients with previously untreated, advanced ALK-positive non-small cell lung cancer
Key exclusion criteria: previous malignancy within the past 3 years; any gastrointestinal disorder or liver disease; history of organ transplant; pregnancy
Interventions
N=152 alectinib (at a dose of 600 mg BID)
N=151 crizotinib (at a dose of 250 mg BID)
Primary outcome
Progression-free survival
68.4
48.7
68.4 %
51.3 %
34.2 %
17.1 %
0.0 %
Alectinib
Crizotinib
Significant increase ▲
NNT = 5
Significant increase in progression-free survival (68.4% vs. 48.7%; AD 19.7%, 95% CI 8.01 to 31.39)
Secondary outcomes
Significant decrease in CNS progression (12% vs. 45%; HR 0.16, 95% CI 0.1 to 0.28)
No significant difference in response rate (82.9% vs. 75.5%; AD 7.4%, 95% CI -1.16 to 15.96)
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients with previously untreated, advanced ALK-positive non-small cell lung cancer, alectinib was superior to crizotinib with respect to a progression-free survival.
Reference
Solange Peters, D Ross Camidge, Alice T Shaw et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838.
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