Positive follow up data from Phase III ALEX study of Alecensa shows reduced risk of disease progression or death in ALK positive NSCLC.- Genentech/Roche

Genentech, a member of the Roche Group announced follow-up data from the Phase III ALEX study, showing that as an initial treatment Alecensa (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57 percent (hazard ratio [HR]= 0.43, 95 percent CI: 0.32-0.58) compared to crizotinib after two years of follow-up in people with anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC), as assessed by the investigator. The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95 percent CI: 17.7 months-NE] versus 10.9 months [95 percent CI: 9.1-12.9]), respectively, as assessed by the investigator. The safety profile for Alecensa was consistent with that observed in previous studies.

The longer-term analysis also included follow-up data for secondary endpoints of the ALEX study. Alecensa demonstrated superior efficacy compared to crizotinib regardless of the presence of central nervous system (CNS) metastases at baseline. Investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa (95 percent CI: 22.4-NE) versus 14.7 months (95 percent CI: 10.8-20.3) with crizotinib (HR=0.47, 95 percent CI: 0.32-0.71). Investigator-assessed median PFS for people with CNS metastases at baseline was 27.7 months in the Alecensa arm (95 percent CI: 9.2-NE) versus 7.4 months (95 percent CI: 6.6-9.6) in the crizotinib arm (HR=0.35, 95 percent CI: 0.22-0.56). The duration of response (DOR) for people who received Alecensa was 33.3 months (95 percent CI: 31.3-NE) compared to 11.1 months (95 percent CI: 7.5-13.0 months) for people who received crizotinib. The data will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 3, 2018, at 8:00 – 11:30 a.m. CDT (Abstract #9043).