Successful trial for Alecensa (alectinib) compared to crizotinib for NSCLC- Genentech + Roche

Genentech, a member of the Roche Group announced that Alecensa (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor, reduced the risk of disease worsening or death (progression-free survival, PFS) by 66 percent compared to crizotinib in Japanese people with advanced or recurrent, ALK-positive non-small cell lung cancer (NSCLC) (hazard ratio [HR]=0.34, 99 percent CI: 0.17-0.70, p<0.0001). Median PFS was not reached in people who received Alecensa (95 percent CI: 20.3 months-not reached) versus 10.2 months median PFS (95 percent CI: 8.2-12.0) in people who received crizotinib. The results were from a pre-specified interim analysis from the Phase III J-ALEX study in people who had not received prior treatment with an ALK inhibitor. There were fewer adverse events (AEs) in the Alecensa arm versus the crizotinib arm. Alecensa demonstrated a safety profile consistent with that observed in previous studies with no new or unexpected AEs.

This is the first investigational study to show Alecensa helped people live longer without their disease getting worse compared to crizotinib.