Roche Announces Results from Multiple Studies on Faricimab for nAMD and DME

The Lancet has published 2 papers that highlight 1-year results from 4 pivotal phase 3 studies of faricimab, an investigational bispecific antibody, in neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME), Roche said in a statement.

All 4 studies, which enrolled more than 3000 individuals in total, met their primary endpoints, showing that individuals treated with faricimab up to every 4 months achieved non-inferior vision gains compared with aflibercept, given every 2 months.

Additionally, approximately half of eligible individuals on faricimab were able to go 4 months between treatments within the first year, and approximately three-quarters could go 3 months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies.

The current standard of care for these potentially blinding conditions requires eye injections as often as once every month.

“We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions,” Levi Garraway, MD, PhD, chief medical officer and head of global product development, said in the statement.

If approved, faricimab would be the first bispecific antibody for the eye, targeting and inhibiting 2 distinct pathways linked to vision-threatening retinal conditions by neutralizing angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A).

The inhibition of both pathways has been shown to have potentially complementary benefits, stabilizing vessels, thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone.

In the TENAYA and LUCERNE studies that examined the effect of faricimab for individuals with nAMD, the average vision gains from baseline at 1 year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared with +5.1 and +6.6 letters in the aflibercept arms.

The studies also measured the proportion of individuals in the faricimab arm who were treated on dosing schedules of every 3 or 4 months during the first year.

Investigators found that 46% of individuals in TENAYA and 45% in LUCERNE were able to be treated every 4 months in the first year.

Additionally, 34% of individuals in TENAYA and 33% in LUCERNE were able to be treated every 3 months.

Combined, nearly 80% of individuals treated with faricimab were able to go 3 months or longer between treatments during the first year. Consistent with vision outcomes, faricimab treatment resulted in a meaningful and comparable reduction in central subfield thickness (CST) and comparable decreases in choroidal neovascularization lesion area and size.

Faricimab was generally well-tolerated in both studies. Adverse events (AEs) were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with nAMD.

In the YOSEMITE and RHINE studies to evaluate faricimab for individuals with DME, the average vision gains from baseline at 1-year were +11.6 and +10.8 eye chart letters in the faricimab treat-and-extend arms, +10.7 and +11.8 letters in the 2-month arms, and +10.9 and +10.3 letters in the aflibercept arms, respectively.

A secondary endpoint in both studies measured the proportion of individuals in the faricimab treat-and-extend arms that achieved dosing schedules of every 3 or 4 months at the end of the first year.

Approximately 53% of faricimab treat-and-extend patients in YOSEMITE and 51% in RHINE achieved 4-month dosing at 1 year.

Additionally, 21% of faricimab treat-and-extend patients in YOSEMITE and 20% in RHINE achieved 3-month dosing. Combined, more than 70% of faricimab treat-and-extend patients were able to go 3 months or longer between treatments at the end of the first year.

Reductions in CST and resolution of intraretinal fluid through the first year consistently favored faricimab over aflibercept. Faricimab was generally well-tolerated in both studies, with a favorable benefit-risk profile.

AEs were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with DME.

Faricimab is under review by the FDA for the treatment of DME and nAMD. The European Medicines Agency is also evaluating the faricimab marketing authorization application for the treatment of DME and nAMD.

Additionally, the BALATON and COMINO trials are under way, evaluating the efficacy and safety of faricimab in individuals with macular edema following retinal vein occlusion.

Reference

The Lancet publishes studies showing Roche’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months. Roche. News release. January 24, 2022. Accessed January 25, 2022. Email.