Abstract
Purpose :
To summarize key learnings and clinical takeaways from the TENAYA/LUCERNE trials in patients with neovascular age-related macular degeneration (nAMD).
Methods :
TENAYA (NCT03823287) and LUCERNE (NCT03823300) were randomized phase 3 trials that enrolled treatment-naïve nAMD patients. Patients (pooled N=1329) were randomized to faricimab 6.0 mg up to every 16 weeks (Q16W; n=665) after 4 initial Q4W doses or aflibercept 2.0 mg Q8W after 3 initial Q4W doses (n=664). Following protocol-defined disease activity assessments at weeks 20 and 24, faricimab-treated patients received fixed dosing up to Q16W until week 60 followed by a treat-and-extend–based regimen. Faricimab treatment intervals could be adjusted (Q8W–Q16W) based on strict, protocol-defined, and clinically relevant changes in best-corrected visual acuity or central subfield thickness (CST) or new macular hemorrhage. Efficacy and safety were assessed at monthly visits through week 112.
Results :
Robust and sustained vision gains and CST reductions through 2 years were achieved with fewer injections with faricimab vs aflibercept. Majority of patients (~80%) achieved extended (≥Q12W) faricimab intervals at year 2, with >60% on Q16W. Patients always on extended (≥Q12W) faricimab intervals achieved stable functional and anatomical outcomes (Figure 1) which may allow for interval extension demonstrated by >50% meeting criteria for potential Q20W dosing (Figure 2). There was greater anatomical improvement (including CST reduction, retinal fluid resolution, and a decrease in maximum serous pigment epithelial detachment [PED] thickness) with faricimab vs aflibercept during the initial 12-week head-to-head dosing phase. First absence of retinal fluid was also achieved faster and with fewer injections with faricimab vs aflibercept. Faricimab was well tolerated through 2 years, with a safety profile comparable to aflibercept.
Conclusions :
For the first time, clinical pearls from the TENAYA/LUCERNE trials are summarized that support comprehensive disease control and extended durability through dual Ang-2 and VEGF-A inhibition with faricimab. Various retinal biomarkers (CST, retinal fluid, PED) demonstrate greater anatomical improvements with faricimab vs aflibercept during the head-to-head dosing phase. Moreover, patients on extended dosing intervals achieved stable outcomes, highlighting the potential for further interval extension.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.