Updated on 20 May 2016
Japanese pharmaceutical company has announced that the results of the Japanese phase III study (J-ALEX) of Alecensa, in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) which will be held between June 3rd and 7the, 2016 in Chicago, IL (USA). Results from the J-ALEX study will be presented at the oral abstract sessions scheduled for June 6, 2016 (CDT).
Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+NSCLC): primary results from the J-ALEX study.
The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen.
The subjects were allocated to either the Alecensa arm or the crizotinib arm of the study in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety, and other endpoints.
In February, 2016, Chugai carried out a prospectively defined interim analysis, and had an independent data monitoring committee examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the J-ALEX study.
As a top pharmaceutical company in the field of oncology in Japan, Chugai believes that early treatment using Alecensa in ALK fusion gene positive NSCLC is expected to prolong these patients' PFS and enable them to face their disease with hope for the future.