Genentech announced that the primary endpoint has not been met in Spectri, the first of two phase 3 studies evaluating the safety and efficacy of lampalizumab, an investigational medicine for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at 1 year (48 weeks). Given the lack of efficacy, further dosing in patients will be interrupted until the results from the second phase 3 study are evaluated.
“Geographic atrophy is a progressive and irreversible disease that impairs vision, and there are currently no available treatments,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “While this result is disappointing, we will continue to evaluate results from Spectri to get a clearer understanding of the data as we await the results of our second phase 3 study, Chroma, anticipated in November.”
About the Spectri and Chroma Studies
The phase 3 trials, called Spectri (NCT02247531) and Chroma (NCT02247479), are identically-designed, double-masked, randomized, global studies evaluating the efficacy and safety of a 10 mg dose of lampalizumab administered every 4 or 6 weeks by intravitreal injection, versus sham injections in people with geographic atrophy (GA) due to age-related macular degeneration (AMD). Together, the studies enrolled more than 1,800 participants in more than 275 sites in over 20 countries.
The primary objective of the studies is to demonstrate a difference in mean change in GA lesion area in patients treated with lampalizumab compared to sham. This efficacy endpoint, evaluated at 1 year (week 48), is measured by fundus autofluorescence (FAF), an imaging technique used to provide information about the size and type of GA lesions in the macula. Secondary objectives of the studies, evaluated at 2 years (96 weeks), focus on assessing the impact of lampalizumab treatment on patients’ visual function.
Lampalizumab is being investigated to determine its efficacy in reducing the progression of geographic atrophy (GA) due to age-related macular degeneration (AMD). Lampalizumab is an antigen-binding fragment (Fab) of a humanized, monoclonal antibody directed against complement factor D (CFD). CFD is a rate-limiting enzyme involved in the activation and amplification of the alternative complement pathway (ACP), a component of the immune system. Dysfunction of the alternative complement pathway has been linked to the pathogenesis of AMD through numerous genetic studies.