In patients with ALK+ non-small-cell lung cancer (NSCLC), alectinib did not yield a prolonged overall survival (OS) compared with crizotinib, according to data from the J-ALEX study being presented at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

This study, conducted by Hiroshige Yoshioka, Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan, and colleagues, provides the final OS data following the interim analysis.

“The primary analysis of the J-ALEX (JapicCTI-132316) study for the ALK-inhibitor naïve ALK+ NSCLC demonstrated superior progression-free survival (PFS) in Japanese patients randomized to the alectinib, compared with those assigned in the crizotinib,” explained Dr Yoshioka et al.

Patients with ALK+ NSCLC were stratified by ECOG performance status, treatment line, and clinical stage. They were then randomized 1:1 to receive either alectinib 300 mg (twice daily; n = 103) or crizotinib 250 mg (twice daily; n = 104).

The primary end point was PFS according to blinded independent review forum, while secondary end points included OS, objective response rate (ORR), and safety.

After the median follow-up of 68.6 months, death events occurred in 40.8% of patients in the alectinib arm, versus 39.4% after the median follow-up of 68.0 months in the crizotinib arm. Additionally, five-year survival rates in for patients in the alectinib and crizotinib arm were 60.85% and 64.11%, respectively; however, median OS was not reached in either arm (hazard ratio, 1.03; 95% CI, 0.67-1.58).

Researchers not that patients in the crizotinib arm had their treatment switched earlier than those receiving alectinib (median time to treatment-switch: 12.3 months vs not estimable). While 78.8% of patients in the crizotinib arm received alectinib as a first subsequent therapy, only 10.7% of alectinib patients received crizotinib.

“In this final J-ALEX OS analysis, prolongation of OS in the alectinib arm was not observed compared to the crizotinib arm. However, OS result may be substantially confounded since 78.8% of the patients in the crizotinib arm received alectinib as initial, subsequent therapy,” concluded Dr Yoshioka at al.—Alexandra Graziano