A swathe of promising new data for Roche’s (Basel, Switzerland) Vabysmo (faricimab-svoa) at the virtual 21st Annual Angiogenesis, Exudation and Degeneration 2024 Conference (Angiogenesis 2024) on February 4 has unveiled promising outcomes in some of the world’s most debilitating retinal diseases.
The data drop comes from three key studies evaluating the drug’s efficacy in neovascular AMD (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).
VOYAGER is a newer non-interventional, prospective, multicenter study that aims to bolster Vabysmo’s clinical trial chops with real-world nAMD and DME data. The preliminary 3-month data from VOYAGER, presented by Prof. Robyn Guymer from the Centre for Eye Research Australia, demonstrated promising visual acuity (VA) gains and rapid reduction of central subfield thickness (CST).
BALATON and COMINO are Phase III studies looking at branching RVO (BRVO: BALATON) and hemiretinal and central RVO (HRVO and CRVO: COMINO), respectively. The data on display at Angiogenesis 2024 was new, long-term 72-week data presented by investigator Dr. Ramin Tadayoni (France) and demonstrated excellent maintenance of VA gains, drying and extended treatment intervals.
VOYAGER trial key insights
Vabysmo, or faricimab, as it is also commonly known, had a coming-out party of sorts with study leader Prof. Guymer’s preliminary VOYAGER trial data announcement. This investigation will examine how the drug’s stellar clinical trial results compare to the harsh light of real-world outcomes in nAMD and DME in a minimum of 5,000 patients across 28 countries.
Initial data from the US, Canada and Japan for 220 eyes of 174 patients with nAMD and 107 eyes of 69 patients with DME indicate improved visual acuity (VA) at month 3. The nAMD patients who switched at study enrollment saw a mean VA improvement of about 6 ETDRS letters from baseline (58.9 to 65), with DME patient ETDRS letter gains of about 2.5 (69.7 to 72.2).
CST also decreased rapidly through month 3 for those who switched to faricimab at enrollment. Faricimab-naive nAMD patients racked up a mean CST loss of about 51 µm, while DME patients saw a mean thinning of 41.7 µm.
Also, investigator tolerance of fluid varied by disease. Prof. Guymer also reported that among the researchers involved, 83.3% and 61.1% favored treat-and-extend regimens for nAMD and DME, respectively.
The VOYAGER study primarily assesses changes in VA over a year. Secondary and exploratory analyses cover anatomical features, treatment impact, outcomes influenced by treatment regimens, drivers of treatment decisions and imaging algorithms. Currently, 5,863 images are available, and future data analysis will include information from more countries.
BALATON and COMINO 72-week data
In addition to the VOYAGER trial, the 72-week data from the Phase 3 BALATON and COMINO studies aimed to shed light on the long-term durability and effectiveness of faricimab.
The BALATON study was conducted in 553 people with BRVO while the COMINO study was conducted in 729 people with CRVO or HRVO.
The studies demonstrate a substantial extension of treatment intervals, with nearly 60% in BALATON and up to 48% in COMINO extending intervals to three or four months.
Participants maintained the vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year, a crucial measure as retinal swelling, measured by CST, relates to visual defects.
For BRVO, vision gains at 72 weeks reached 18.1 letters with a 310.9 µm reduction in CST. CRVO results showed vision gains of 16.9 letters and a 465.9 µm CST reduction at 72 weeks.
Dr. Levi Garraway, Genentech’s (South San Francisco, USA) chief medical officer and head of global product development, noted that these results mark the first instance of maintaining vision and anatomical improvements for over a year in global Phase 3 studies for both BRVO and CRVO, reinforcing Vabysmo’s efficacy as a long-term and effective treatment for retinal conditions. Genentech co-developed the drug with Roche as an independent subsidiary of the Swiss pharmaceutical giant.
“These long-term results build on the strong clinical and real-world data reinforcing Vabysmo as an effective treatment option for people affected by retinal conditions that can cause vision loss,” Dr. Garraway said.
Dual inhibition approach shows promise
Vabysmo’s novel feature is its dual-pathway inhibition of angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), and the latest data gives faricimab promising evidence for this unique approach, its potential in treating exudative retinal diseases.
FDA-approved on January 28, 2022, it was the first bispecific antibody to be approved for treating eye disorders. Faricimab’s expansion into the RVO treatment arena underscores its versatility and potential to address a broader spectrum of retinal diseases.
With the promising preliminary results from the VOYAGER trial and the comprehensive insights from the BALATON and COMINO studies, faricimab has positioned itself as a formidable player in a highly competitive medical retina landscape.
Reference
- Genentech Press Release. New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO) Available at: https://www.gene.com/media/press-releases/15017/2024-01-31/new-long-term-data-for-genentechs-vabysm Accessed on 09 February 2024.
