Chugai Pharmaceutical announced that updated data from the global phase III study (the ALEX study) for Alecensa was presented the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The ALEX study compared Alecensa and crizotinib as the first-line therapy for patients with ALK fusion gene positive non-small cell lung cancer (NSCLC).
Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC.
Dr. Osamu Okuda, Chugai's president and COO, said "This five-year follow-up data from the ALEX study shows the long-term benefits of Alecensa as the first-line treatment of ALK-positive NSCLC. This reaffirms the position of Alecensa as one of the standard treatments."
At the updated data cut-off point, median duration of follow-up was 48.2 months (range: 0.5 - 62.7) and 23.3 months (range: 0.3 - 60.6) in the Alecensa and crizotinib arms, respectively. The number of overall survival (OS) events was 37% of the ITT population, median OS in the crizotinib arm was 57.4 months (95%CI: 34.6 – not estimable) and not estimable in the Alecensa arm (HR=0.67, 95%CI: 0.46 - 0.98). The 5-year survival rate was 62.5% (95%CI: 54.3 - 70.8) and 45.5% (95%CI: 33.6 - 57.4) in the Alecensa and crizotinib arms, respectively (secondary endpoint).
In patients with CNS metastases at baseline, the OS hazard ratio was 0.58 (95%CI: 0.34 - 1.00) and 0.76 (95%CI: 0.45 - 1.26) in patients without CNS metastases at baseline (secondary endpoint).
No new safety signals were observed, and the safety profile of Alecensa was consistent with previous reports.
The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.