Genentech’s Faricimab Meets Primary Endpoint in Two Global Phase 3 Studies in Wet AMD
Genentech announced positive topline results from two identically designed global phase 3 studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with wet age-related macular degeneration (AMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were noninferior to those receiving aflibercept injections every 8 weeks. Nearly half (45%) of people in both studies were treated with faricimab every 16 weeks during the first year. This is the first time this level of durability has been achieved in a phase 3 study of an injectable eye medicine for wet AMD. In both studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified, according to a company news release.
Current standards of care, injections that inhibit vascular endothelial growth factor (VEGF), have significantly reduced the rates of vision loss due to wet AMD. However, VEGF is not the only pathway involved in the development and progression of this complex condition. With anti-VEGF monotherapies, people with wet AMD have to visit their ophthalmologist as often as monthly for eye injections to help maintain vision gains and/or prevent vision loss. This high treatment burden can lead to under-treatment and potentially less than optimal vision outcomes. It has been more than 15 years since a medicine with a new mechanism of action has been approved to treat wet AMD. Faricimab is the first bispecific antibody designed for the eye. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including wet AMD.
“These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “We have now seen positive and consistent results in four phase 3 studies for faricimab across both neovascular age-related macular degeneration and diabetic macular edema. We look forward to submitting these data to global regulatory authorities, with the aim of bringing this promising treatment option to patients as soon as possible.”
The findings from TENAYA and LUCERNE build on positive topline results from the phase 3 YOSEMITE and RHINE studies, announced in December 2020, which support the potential of faricimab as a treatment option for diabetic macular edema, a leading cause of vision loss among working-age adults.
Detailed results from all four 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 to health authorities around the world, including the FDA.
About the TENAYA and LUCERNE Studies
TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomized, multicenter, double-masked, global phase 3 studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every eight, 12 or 16 weeks, selected based on objective assessment of disease activity at weeks 20 and 24; aflibercept 2.0 mg administered at fixed 8-week intervals. In both 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 from baseline through week 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every eight, 12 and 16 weeks; the percentage of participants achieving a gain, and the percentage avoiding a loss of 15 letters or more in BCVA from baseline over time; and change in central subfield thickness from baseline over time.