The CNS objective response rate was 81% (95% CI, 58-95) in the alectinib arm versus 50% (95% CI, 28-72) in the crizotinib arm. The complete response rates were 38% versus 5%, respectively. CNS response duration was 12 months or longer in 59% of the alectinib group versus 36% of the crizotinib group.
“The high level of CNS activity shown with alectinib in the primary analysis is consistent with the fact that fewer patients treated with alectinib reported clinically meaningful worsening in health-related QoL or cognitive function compared to crizotinib,” Pérol said in remarks about the findings reported at ELCC.
“Finally, the superior tolerability profile of alectinib compared to crizotinib shown in this analysis is consistent with the adverse events profile recorded during the study,” he said.
In the results that led to the FDA approval, Alectinib was associated with fewer serious AEs. In the ALEX trial, 41% of patients assigned to alectinib experienced grade ≥3 AEs compared with 50% in the crizotinib group. Additionally, AEs leading to discontinuation (11% vs 13%), dose reduction (16% vs 21%), and dose interruption (19% vs 25%) were all lower with alectinib.2
<<< 2018 European Lung Cancer Congress
- FDA Approves Genentech’s Alecensa (Alectinib) as First-Line Treatment for People with Specific Type of Lung Cancer. Genentech. Available at: http://bit.ly/2zmLda7. Accessed April 12, 2018.
- Pérol M, Peters S, Pavlakis N, et al. Patient-reported outcomes (PROs) in ALEX. A phase III study of alectinib (ALEC) vs crizotinib (CRIZ in non – small lung cancer (NSCLC). Abstract 138PD. Presented at: the 2018 European Lung Cancer Conference; April 11-14; Geneva, Switzerland.