Genentech reports detailed Phase III data for Alecensa as first-line treatment of NSCLC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported additional data from the Phase III ALEX trial in 303 treatment-naïve patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) showing that first-line treatment with twice-daily 600 mg oral Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) significantly reduced the risk of disease progression or death by 53% vs. Xalkori crizotinib (HR=0.47, 95% CI: 0.34, 0.65, p<0.0001). Median progression-free survival (PFS) by investigator assessment, the primary endpoint, was not reached in patients who received Alecensa vs. 11.1 months for Xalkori. Median PFS by Independent Review Committee (IRC) assessment was 25.7 months for Alecensa vs. 10.4 months for Xalkori (p<0.0001). Alecensa also significantly reduced the risk of CNS disease progression, a secondary endpoint, by 84% vs. Xalkori (HR=0.16, 95% CI: 0.1, 0.28, p<0.0001). Data were presented at the American Society of Clinical Oncology meeting in Chicago and published in the New England Journal of Medicine.

In April, Genentech reported that Alecensa met the primary endpoint of improving PFS vs. Xalkori (see BioCentury, April 17). Other secondary endpoints in the open-label, international trial include objective response rate (ORR), duration of response, overall survival (OS), health-related quality of life (QOL) and safety...