• Spectri study did not meet its primary endpoint of reducing mean change in geographic atrophy lesion area in patients treated with lampalizumab compared with sham treatment;
• Safety profile was in line with previous lampalizumab trials and other intravitreal therapies;
• Results from the second Phase III study, Chroma, are expected in November 2017.
Genentech, a member of the Roche Group, today announced that the primary endpoint has not been met in Spectri, the first of two Phase III 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 one year (48 weeks). Given the lack of efficacy, further dosing in patients will be interrupted until the results from the second Phase III study are evaluated.
“Geographic atrophy is a progressive and irreversible disease that impairs vision, and there are currently no available treatments,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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 III study, Chroma, anticipated in November.”
About the Spectri and Chroma Studies
The Phase III 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 four or six 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 one 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 two 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.
About Geographic Atrophy
Geographic atrophy (GA) is a progressive and irreversible form of age-related macular degeneration (AMD), affecting more than five million people worldwide. Visual impairment associated with GA tends to affect both eyes in many individuals. People with GA report visual problems with activities of daily living including reading, driving, recognizing faces, and activities in dim or low light. GA represents a significant unmet medical need, as there are no approved therapies for this condition.
About Genentech in Ophthalmology
Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including GA, neovascular AMD, diabetic macular edema (DME), diabetic retinopathy (DR), and other retinal diseases.
Genentech medicines are indicated to treat several ophthalmic diseases and conditions including wet AMD, diabetic macular edema, diabetic retinopathy, macular edema secondary to retinal vein occlusion, myopic choroidal neovascularization and giant cell arteritis, a form of vasculitis that can lead to blindness.
Founded more than 40 years ago, Genentech (gene.com) is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.