Roche gir oppdatering på første lampalizumab fase III-studie for geografisk atrofi, en avansert form for aldersrelatert makuladegenerasjon

Roche kunngjorde fredag at det primære endepunktet ikke er oppfylt i Spectri-studien. Dette er den første av to fase III-studier som evaluerer sikkerheten og effekten av lampalizumab, en utprøvende medisin for behandling av geografisk atrofi (GA) som følge av aldersrelatert makuladegenerasjon (AMD). 

Lampalizumab reduserte ikke gjennomsnittlig endring i GA-lesjonsområdet sammenlignet med placebo etter ett år (48 uker). På grunn av manglende effekt, vil ytterligere dosering hos pasienter bli stanset til resultatene fra den andre fase III-studien blir evaluert.

Les Roches internasjonale pressemelding for nærmere informasjon:

Roche provides update on first lampalizumab phase III study for geographic atrophy, an advanced form of age-related macular degeneration

• 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, will be evaluated in November 2017

Roche (SIX: RO, ROG; OTCQX: RHHBY) 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 1 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, MD, Roche’s Chief Medical Officer and Global Head of 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 Studies1,2

The phase III trials, called Spectri (GX29185; NCT02247531) and Chroma (GX29176; NCT02247479), are identically-designed, double-masked, randomised, 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 GA due to 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.

About lampalizumab

Lampalizumab is being investigated to determine its efficacy in reducing the progression of GA due to AMD. Lampalizumab is an antigen-binding fragment (Fab) of a humanised, monoclonal antibody directed against complement factor D (CFD). CFD is a rate-limiting enzyme in the activation and amplification of the alternative complement pathway (ACP), a component of the immune system. Dysfunction of the ACP has been linked to the pathogenesis of AMD through numerous genetic studies.3,4,5

About geographic atrophy (GA)

GA is a progressive and irreversible form of AMD, affecting more than 5 million people worldwide.6 Visual impairment associated with GA tends to affect both eyes in many individuals.7,8 People with GA report visual problems with activities of daily living – including reading, driving, recognising faces, and activities in dim or low light.9,10,11 GA represents a significant unmet medical need, as there are no approved therapies for this condition.

About Roche in ophthalmology

Roche 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.

Roche’s ophthalmology medicines include Lucentis® (ranibizumab) in the US, which is indicated in the United States for the treatment of neovascular AMD, DME, DR with or without DME; macular edema secondary to retinal vein occlusion and myopic choroidal neovascularisation.