Alecensa Bests Xalkori in Lung Cancer Trial

Treatment extends PFS by more than one year in late-stage study

In a new phase 3 study, alectinib (Alecensa, Roche) significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) by more than half (53%) compared with crizotinib (Xalkori, Pfizer) when administered as first-line treatment in patients with anaplastic lymphoma kinase (ALK)-positive advanced non–small-cell lung cancer (NSCLC) (hazard ratio [HR], 0.47; P

Median PFS assessed by an independent review committee, a secondary endpoint, was 25.7 months for subjects treated with alectinib compared with 10.4 months in those treated with crizotinib (HR, 0.50; P

The randomized ALEX trial, which included 303 subjects in 31 countries, also demonstrated that alectinib reduced the risk of disease progression in the central nervous system (CNS) by 84% compared with crizotinib (HR, 0.16; P

Alectinib is an oral medication being developed for patients with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a history of light or no smoking. It is almost always found in patients with adenocarcinoma, a specific type of NSCLC. Alectinib is approved in the United States for the treatment of patients with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib.

Source: Roche; June 5, 2017.