The Lancet Publishes Four Phase 3 Studies of Roche’s Faricimab Demonstrating Non-Inferior Efficacy to Eylea with Extended Dosing Intervals up to Every 4 Months in nAMD and DME
Jan 25, 2022 04:21
CST Updated
04:21
Roche
Oncology Drug Research, Development, and Manufacturing
Faricimab Structure (Source: cahiers-ophtalmologie.fr)
News on January 24, 2022 /BioValleyBIOON/ -- Roche recently announced that The Lancet, an international medical journal, has published two articles highlightingBispecific antibody faricimab for the treatment of neovascular or "wet" age-related macular degeneration (nAMD) andDiabetesDiabetic Macular Edema (DME)One-year results from four pivotal Phase III studies. DME and nAMD are two common causes of blindness, and the current standard of care for these diseases requires monthly eye injections.
These four studies enrolled more than 3,000 patients and all reached their primary endpoints:Compared to patients treated with Eylea (aflibercept) using an every-two-month dosing regimen, patients treated with faricimab using an every-four-month dosing regimen demonstrated non-inferiority in terms of visual acuity gain.Notably, in the first year of the TENAYA and LUCERNE nAMD studies, as well as the YOSEMITE and RHINE DME studies,Approximately half of the patients eligible for extended faricimab dosing were able to receive treatment every 4 months, and about three-quarters of the patients were able to receive treatment every 3 months or longer.In all four studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified.
Levi Garraway, MD, Chief Medical Officer and Head of Global Product Development at Roche, stated: "These data published in The Lancet reinforce the potential of faricimab as a significant treatment option that may help improve and maintain vision while extending treatment intervals to four months. We remain steadfast in our commitment to developing new medicines like faricimab, which will assist many patients with severe retinal diseases in preserving their vision."
Although anti-vascular endothelial growth factor (VEGF) monotherapy injections significantly reduce vision loss in patients with DME and nAMD, the treatment burden associated with frequent eye injections and doctor visits may lead to undertreatment and could result in suboptimal visual outcomes.
Faricimab is the first bispecific antibody specifically designed for the eye. Unlike current DME and nAMD treatments that inhibit the VEGF pathway, faricimab targets two different pathways—through angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A)—both of which drive a variety of retinal diseases, including nAMD and DME.Ang-2 and VEGF-A lead to vision loss by disrupting vascular stability, causing the formation of new leaky blood vessels, and increasing inflammatory responses. By simultaneously blocking these two pathways, faricimab aims to stabilize blood vessels and reduce inflammation and leakage more effectively than inhibiting either pathway alone. This may improve vision more than anti-VEGF therapy alone, potentially reducing the frequency of required eye injections.
Currently, the marketing application for faricimab in treating nAMD and DME is under review in the United States.FDAAnd the review of the European Medicines Agency (EMA). If approved, faricimab will become the first and only novel ophthalmic drug designed to target two distinct signaling pathways that drive retinal diseases. By offering lasting visual effects with fewer ocular injections than the current standard of care, it will provide a new treatment option for millions of patients with nAMD and DME.
DiabetesMacular Edema - DME (Image Source: bceye.com)
YOSEMITE and RHINE are two identically designed global Phase 3 studies inDiabetesIn patients with diabetic macular edema (DME), two dosing regimens of faricimab (once every 2 months or a personalized treatment interval [PTI] of up to once every 4 months) were evaluated and compared with the Eylea regimen of once every 2 months. Patients in the PTI group could receive faricimab treatment once every 1, 2, 3, or 4 months, with adjustments based on their disease activity.
Both studies met the primary endpoint: faricimab consistently demonstrated non-inferiority to Eylea in terms of visual acuity improvement.In the YOSEMITE study, the average vision improvement in the faricimab PTI group and the 2-month group was +11.6 and +10.8 eye chart letters, respectively, compared to +10.9 letters in the Eylea group. In the RHINE study, the average vision improvement in the faricimab PTI group and the 2-month group was +10.7 and +11.8 letters, respectively, compared to +10.3 letters in the Eylea group.
The secondary endpoints of these two studies were to measure the proportion of patients in the faricimab PTI group who reached a dosing schedule of once every 3 months or once every 4 months at the end of the first year. Importantly, in the YOSEMITE study, 53% (n=151/286) of patients in the faricimab PTI group, and in the RHINE study, 51% (n=157/308) of patients in the faricimab PTI group reached a dosing schedule of once every 4 months within the first year. Additionally, in the YOSEMITE and RHINE studies, 21% (n=60/286) and 20% (n=62/308) of patients in the faricimab PTI group reached a dosing schedule of once every 3 months. Altogether, more than 70% of patients in the faricimab PTI group were able to maintain an interval of 3 months or longer between treatments by the end of the first year. In both studies, faricimab administered once every 4 months showed a greater reduction in central subfield thickness (CST) compared with Eylea administered once every 2 months.
Neovascular Age-Related Macular Degeneration (nAMD, Image Source: researchgate.net)
TENAYA and LUCERNE are two identically designed global Phase III studies conducted in patients with neovascular age-related macular degeneration (nAMD). The studies evaluated faricimab dosing regimens given every 2 months, every 3 months, or every 4 months (based on disease activity assessments at weeks 20 and 24) and compared them with Eylea administered every 2 months.
Both studies met the primary endpoint: faricimab consistently demonstrated non-inferiority to Eylea in terms of visual acuity improvement.In the TENAYA and LUCERNE studies, the mean vision gains from baseline in the faricimab group were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the Eylea group.
Two studies also measured the proportion of patients receiving faricimab every 3 or 4 months during the first year. Importantly, in the TENAYA study, 46% (n=144/315) and in the LUCERNE study, 45% (n=142/316) of patients were able to receive faricimab every 4 months in the first year. Additionally, in the TENAYA study, 34% (n=107/315) and in the LUCERNE study, 33% (n=104/316) of patients were able to receive faricimab every 3 months. Altogether, nearly 80% of patients in the faricimab treatment group were able to maintain a dosing interval of every 3 months or longer during the first year. In these two studies, compared with Eylea administered every 2 months, faricimab administered every 4 months demonstrated greater reductions in central subfield thickness (CST). (Bioon.com)