Genentech's second phase 3 trial for Alecensa showed that the drug significantly reduced the risk of disease worsening or death by 53% versus crizotinib when given as initial treatment for people with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer.
Median progression-free survival reported by the investigators, the primary endpoint of the study, was not yet reached in people who received Alecensa versus 11.1 months in those who received crizotinib.
The secondary endpoint of median progression-free survival assessed by an independent review committee was 25.7 months for those who received Alecensa versus 10.4 months for people who received crizotinib.
Alecensa reduced the risk of disease progression in the central nervous system by 84%. The 12-month cumulative rate of central nervous system progression for people with or without existing central nervous system metastases at baseline was 9.4% for Alecensa and 41.4% for crizotinib.
Genentech will submit the results to global health authorities, including the U.S. Food and Drug Administration. In September 2016, The U.S. FDA granted the drug breakthrough therapy designation for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer in patients who have not received prior treatment with an anaplastic lymphoma kinase inhibitor.
Alecensa received accelerated approval from the U.S. FDA in December 2015 for the treatment of people with anaplastic lymphoma kinase-positive non-small cell lung cancer who have progressed on or are intolerant to crizotinib.
Genentech is a part of Roche Holding Ltd.