Lampalizumab: Additional Phase II data

Roche's Genentech Inc. unit disclosed the details of an exploratory biomarker from the single-blind Phase II MAHALO trial evaluating lampalizumab to treat GA associated with AMD. In August, data from 129 patients in MAHALO showed that once-monthly lampalizumab met the primary endpoint of reducing GA area as assessed by FAF from baseline to 18 months vs. sham injection. At the time, Roche also said that once-monthly lampalizumab reduced GA area at 18 months by 44% relative to sham control in a subgroup of patients positive for an undisclosed biomarker (p<0.005) (see BioCentury, Sept. 2). Genentech reported at the American Academy of Ophthalmology meeting in New Orleans that the biomarker is complement factor I (CFI) and that the 53 patients who tested positive for disease-associated genetic polymorphisms in CFI had the greatest benefit from lampalizumab in MAHALO. Genentech also said that sham control-treated patients who were positive for polymorphisms in CFI showed the most rapid progression of GA area compared to sham control-treated patients who were negative for polymorphisms in CFI. The company said the data suggest CFI is both "prognostic for GA area progression and predictive for lampalizumab treatment response." ...