Genentech’s Faricimab Meets Primary Endpoint and Shows Strong Durability Across Two Global Phase 3 Studies for DME
Genentech announced positive topline results from two identically designed global phase 3 studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME).
Both studies met their primary endpoint and showed that faricimab given every 8 weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared to aflibercept given every 8 weeks. Faricimab was generally well-tolerated with no new safety signals identified. The studies each have three treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed 8-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase.
In a secondary endpoint, across both studies, more than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year 1. This is the first time any investigational medicine has achieved this level of durability in a phase 3 study of people with DME.
Faricimab is the first investigational bispecific antibody designed for the eye.5 It targets two distinct pathways—via angiopoietin-2 (Ang-2) and VEGF-A—that drive a number of retinal conditions, including DME.6
“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible.”
In addition to the YOSEMITE and RHINE studies, the phase 3 Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME.7 Faricimab is also being studied in the phase 3 TENAYA and LUCERNE studies as a potential treatment for neovascular or wet age-related macular degeneration (nAMD). Detailed results from the YOSEMITE and RHINE studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine and submitted for approval for the treatment of DME around the world.
About the YOSEMITE and RHINE Studies5,12,13
YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomized, multicenter, double-masked, global phase 3 studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people living with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered at personalized dosing intervals of up to 16 weeks; faricimab 6.0 mg administered at fixed eight-week intervals; aflibercept 2.0 mg administered at fixed 8-week intervals. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.
The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at 1 year. Secondary endpoints include: safety; the percentage of participants in the personalized dosing arm receiving treatment every four, eight, 12 and 16 weeks, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain of at least 15 letters in BCVA from baseline over time; the percentage of participants avoiding a loss of at least 15 letters in BCVA from baseline over time; and change in central subfield thickness from baseline over time.
References
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[5] Roche/Genentech data on file.
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