BioCentury
ARTICLE | Clinical News

Genentech details biomarkers for lampalizumab

November 19, 2013 1:57 AM UTC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) disclosed the details of an exploratory biomarker for the company's lampalizumab ( RG7417), which is in development to treat geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD). In August, the companies reported that once-monthly lampalizumab met the primary endpoint of reducing GA area in the Phase II MAHALO trial. At the time, Roche also said once-monthly lampalizumab had reduced GA area at month 18 by 44% in a subgroup of patients positive for a biomarker, but the pharma did not disclose the biomarker (p<0.005) (see BioCentury Extra, Aug. 27).

Genentech said the biomarker is complement factor I (CFI), and that patients testing positive for disease-associated genetic polymorphisms in CFI had the greatest benefit from lampalizumab in MAHALO. The company said the data suggest CFI is both "prognostic for GA area progression and predictive for lampalizumab treatment response." Genentech said it analyzed four genetic biomarkers in MAHALO -- CFI, complement factor H (CFH), complement 3 (C3) and complement 2 (C2)/ complement factor B (CFB). The biomarker analyses were not pre-specified. ...