The global, randomized Phase III ALEX study has demonstrated that Alecensa® (alectinib) as an initial treatment for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) significantly reduced the risk of disease worsening or death when compared directly to Xalkori (crizotinib). This is the second Phase III trial to show that Alecensa was superior as an initial treatment compared to Xalkori in this type of lung cancer. The safety profile of Alecensa was consistent with that observed in previous studies, with no new or unexpected adverse events.
Full data from the clinical study will be submitted to the U.S. Food and Drug Administration (FDA), which in September 2016 granted Alecensa Breakthrough Therapy Designation for the treatment of people with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.
ALK-positive NSCLC is a distinct form of lung cancer commonly diagnosed in younger people (median age 52). Approximately 54 percent of cases are found in women. ALK-positive NSCLC is also generally found in those with a light or non-smoking history.
Alecensa is a kinase inhibitor approved for the treatment of people with ALK positive, metastatic NSCLC who have progressed on or are intolerant to Xalkori. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
About the ALEX study
ALEX was designed to evaluate the effectiveness and safety of Alecensa versus Xalkori in previously untreated individuals with ALK-positive NSCLC whose cancers were characterized as ALK-positive by a uniform assay, a companion immunohistochemistry test developed by Roche Tissue Diagnostics. Individuals were treated with either Alecensa or Xalkori and directly compared. The multicenter study was conducted in 303 people across 161 sites in 31 countries.
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