Efficacy
In the ALEX trial after a median follow up of 18.6 months in the alectinib group, the median PFS was not estimable (NE) (95%CI 17.7 months-NE) in the alectinib arm versus 11.1 months (95%CI 9.1-13.1) in the crizotinib arm. Investigator assessed PFS was 68.4% (95%CI 61.0-75.9) in the alectinib group versus 48.7% (95%CI 40.4-56.9) in the crizotinib group.r An updated analysis of the ALEX trial showed an investigator-assessed PFS of 34.8 months with alectinib versus 10.9 months with crizotinib (HR 0.43, 95%CI 0.32-0.58).r OS data remains immature with a median follow up of 48.2 months and 23.3 months in the alectinib and crizotinib groups, respectively. Median OS has not been reached (NR) with alectinib and was 57.4 months with crizotinib (stratified HR 0.67, 95%CI 0.46-0.98), 5-year OS rate of 62.5% with alectinib and 45.5% with crizotinib.r
Cumulative incidence of CNS progression ALEX trialr
© N Engl J Med 2017
PFS updated analysis of ALEX trialr
© J Thorac Oncol 2019
OS updated analysis of ALEX trialr
© J Thorac Oncol 2019
In the J-ALEX trial after a median follow-up of 12 months, the median PFS was NE (95%CI 20.3 months-NE) with alectinib versus 10.2 months (95%CI 8.2-12) with crizotinib (HR 0.34, 99.7%CI 0.17-0.71, stratified log-rank test p<0.0001).r After a median follow-up of 42.4 months and 42.2 months in alectinib and crizotinib arms, respectively a median PFS of 34.1 months in the alectinib group versus 10.2 months in the crizotinib group were observed (HR 0.37, 95%CI 0.26-0.52).r After a median follow-up of 68.6 months in the alectinib arm and 68.0 months in the crizotinib arm, superiority of alectinib to crizotinib in terms of OS was not confirmed (HR 1.03, 95.04% CI 0.67-1.58, p=0.91). Median OS was not reached in any of the arms. 5-year OS rates were 60.9% (95% CI 51.4-70.3) with alectinib and 64.1% (95% CI 54.9-73.4) with crizotinib.r The OS results may have been confounded by the crossover of a large proportion of patients in crizotinib arm (78.8%) to alectinib following disease progression.
Final OS in the ITT population of J-ALEX trialr
© ESMO Open 2022