First-Line Alectinib Effective in Asian Patients With ALK-Positive Advanced NSCLC
Alectinib substantially improved outcomes in Asian patients with treatment-naive, ALK-positive NSCLC.
|The following article features coverage from the European Society for Medical Oncology (ESMO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) demonstrated improved outcomes alectinib compared with crizotinib in the first-line setting, according to the results of the phase 3 ALESIA trial presented at the ESMO 2018 Congress in Munich, Germany.1
In the global phase 3 ALEX trial, alectinib significantly prolonged progression-free survival (PFS) compared with crizotinib among patients with ALK-positive NSCLC without prior treatment (hazard ratio [HR], 0.47; 95% CI, 0.34-0.65). The purpose of this trial was to determine if Asian patients would experience similar benefits as seen in the population of the ALEX trial.
Investigators of the open-label, phase 3 ALESIA trial randomly assigned 187 Asian patients with ALK-positive stage IIIB or stage IV NSCLC 2:1 to receive alectinib or crizotinib. All patients had not received prior systemic treatment and patients with asymptomatic central nervous system (CNS) metastases were allowed to enroll. The primary end point was PFS (assessed via investigator analysis) and the secondary end points were PFS (assessed by an independent review committee), time to CNS progression, objective response rate (ORR), duration of response (DOR), overall survival (OS), CNS ORR, quality of life, and safety.
Alectinib met its primary end point, with a significant improvement in PFS with a median not yet reached compared with 11.1 months with crizotinib (HR, 0.22; 95% CI, 0.13-0.38; P< .0001). PFS was found to be similar when assessed by independent analysis (HR, 0.37; 95% CI, 0.22-0.61; P < .0001). The OS data are immature; the median in both arms had not yet been reached.
The ORR was higher with alectinib, at 91.2% compared with 77.4% with crizotinib (P= .0095). The DOR was also longer with alectinib, with a median not yet reached compared with 9.3 months with crizotinib. The time to CNS progression was also not yet reached with alectinib, but was 10.7 months with crizotinib (HR, 0.14; 95% CI, 0.06-0.30; P< .0001).
Grade 3 to grade 5 adverse events (AEs) were less common with alectinib, with a rate of 29% compared with 48% with crizotinib. The rate of serious AEs was 15% and 26% with alectinib and crizotinib, respectively. Discontinuation occurred in 7% and 10% of patients in the alectinib and crizotinib arms, respectively; discontinuation was due to AEs.
The authors concluded that the “ALESIA study results are consistent with the global ALEX study and confirm the clinical benefit of alectinib in Asian patients with advanced ALK-positive NSCLC.”
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- Zhou C, et al. Primary results of ALESIA: a randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naive ALK+ advanced NSCLC. Presented at: the ESMO 2018 Congress; Munich, Germany: October 19-23, 2018. Abstract LBA10.