Phase III ALESIA study of Alecensa meets primary endpoint in ALK+ NSCLC.- Roche.

Roche will announce results from the phase III ALESIA study, showing that Alecensa (alectinib) met its primary endpoint of investigator-assessed (INV) progression-free survival (PFS) as monotherapy treatment in Asian patients with anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). Alecensa significantly reduced the risk of disease worsening or death by 78%, compared to crizotinib, when given as an initial (first-line) monotherapy in Asian patients with ALK-positive advanced or metastatic NSCLC (hazard ratio [HR]=0.22, 95% CI: 0.13-0.38). Median PFS reported by the investigators was not yet reached in patients who received Alecensa (95% CI: 20.3 months-not reached) versus 11.1 months (95% CI: 9.1-13.0 months) in those who received crizotinib.

The safety profile of Alecensa was consistent with that observed in previous studies. Median PFS reported by an independent review committee (IRC), a secondary endpoint, was not yet reached in patients who received Alecensa (95% CI: 16.7 months-not reached), versus 10.7 months (95% CI: 7.4 months-not reached) in patients who received crizotinib (HR=0.37, 95% CI: 0.22-0.61). The phase III ALESIA study also demonstrated that compared to crizotinib, Alecensa reduced the risk of disease progression in the central nervous system (CNS), another secondary endpoint in the study, by 86% (HR=0.14, 95% CI: 0.06-0.30). The ALESIA data are being officially presented at the European Society for Medical Oncology (ESMO) 2018 Congress.