Abstract
Purpose :
Year 2 data from the TENAYA/LUCERNE (NCT03823287/NCT03823300) trials demonstrate that dual inhibition of the angiopoietin-2/vascular endothelial growth factor-A pathways with faricimab (FAR) promotes vascular stability and durable efficacy in patients with neovascular age-related macular degeneration (nAMD). This study evaluated patient-level imaging biomarkers and visual outcomes with a focus on personalized treat-and-extend-based (T&E) regimen decision making in patients treated for 2 years.
Methods :
TENAYA/LUCERNE were randomized, active comparator–controlled, double-masked, 112-week trials. Treatment-naïve patients with nAMD were randomized to FAR 6.0 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses or aflibercept (AFL) 2.0 mg Q8W through study end after 3 initial Q4W doses. Following protocol-defined disease activity assessments at weeks 20 and 24, FAR patients received fixed up to Q16W dosing until week 60, after which they followed a T&E regimen (personalized treatment interval per protocol). During the T&E period, FAR treatment interval decisions were based on clinically relevant markers of disease activity: changes in protocol-defined visual acuity (VA), retinal anatomy assessed with optical coherence tomography, or new macular hemorrhage.
Results :
1329 patients were enrolled (TENAYA, N = 671; LUCERNE, N = 658). Mean change in best-corrected VA and central subfield thickness (CST; averaged over weeks 104–112) were: FAR, 4.4 letters and −148.4 µm; AFL, 4.3 letters and −144.0 µm, respectively. FAR-treated patients received fewer injections than AFL-treated patients overall (week 108 median: 10 vs 15) and during the T&E phase (weeks 60–108 median: 3 vs 6). At week 112, > 60% of FAR-treated patients achieved Q16W dosing and 77.8% achieved ≥ Q12W dosing. Among patients who achieved Q16W dosing at week 60, 68.9% remained on Q16W without deviation during the T&E phase. Among patients who achieved Q12W dosing at week 60, 58.6% extended to Q16W dosing by week 112. FAR was well tolerated, with an acceptable safety profile. We will present representative cases of FAR-treated patients through year 2 of TENAYA/LUCERNE, including retinal images and treatment intervals.
Conclusions :
Visual and anatomical improvements were maintained with individualized faricimab dosing in patients with nAMD, with more patients achieving Q16W dosing in year 2 of TENAYA/LUCERNE.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.