Roche confirmed that the drug met its primary endpoint in the Phase 3 study, "significantly reducing" the risk of disease progression or death by 78% when used as a first-line treatment compared to Pfizer’s Xalkori (crizotinib). Median progression-free survival (PFS) for Xalkori stood at 11.1 months, but the same metric was not yet reached by the patients receiving Alecensa and could not be presented.

Additionally, Alecensa was found to minimise the risk of a tumour spreading or growing in the brain or central nervous system by 86%.

Roche said that this study marked the third time that its drug had beaten Pfizer’s in terms of PFS in ALK-positive advanced or metastatic NSCLC, stressing that the investigation was designed to complement the findings of the global ALEX study, and not actually to prove its superiority to Xalkori. The study also served to complete a post-approval agreement with China’s National Drug Administration and will support its regulatory approval in the region.

"The ALESIA study supports the use of Alecensa as the standard of care for newly diagnosed advanced or metastatic ALK-positive lung cancer across multiple populations," remarked Dr Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche. "Alecensa has received rapid regulatory approvals for first-line treatment in 65 countries to date, including in China."

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