Extended treatment outcomes and the potential for Q20W dosing with faricimab in nAMD: a post hoc analysis of the pivotal TENAYA/LUCERNE trials

Abstract

Purpose : A post hoc analysis to assess the impact of maintaining extended (at least every 12 weeks [≥ Q12W]) faricimab dosing and evaluate how many patients potentially could have extended to Q20W dosing in the TENAYA/LUCERNE (NCT03823287/NCT03823300) nAMD trials.

Methods : Patients received faricimab 6.0 mg up to Q16W after four Q4W doses or aflibercept 2.0 mg Q8W after three Q4W doses. Following disease activity assessments at weeks 20/24, faricimab-treated patients received fixed dosing until week 60 then a treat-and-extend (T&E)–based regimen. We evaluated efficacy outcomes at year 2 (averaged over weeks 104–112) of faricimab-treated patients always on ≥ Q12W and always on Q16W, and applied T&E criteria to patients who received ≥ 1 dose during the T&E phase to assess if they met criteria for Q20W extension.

Results : Faricimab-treated patients always on ≥ Q12W and always on Q16W dosing maintained best-corrected visual acuity gains through year 2 compared with the overall faricimab arm (mean [standard deviation]; always ≥ Q12W, +6.6 [12.9] letters; always Q16W, +7.5 [11.8] letters; overall faricimab arm, +4.7 [14.9] letters). Faricimab-treated patients always on extended dosing had reduced central subfield thickness from baseline through year 2 (always ≥ Q12W, –142.8 [112.7] µm; always Q16W, –145.3 [110.8] µm; overall faricimab arm, –47.1 [125.7] µm). 56% of faricimab-treated patients who received ≥ 1 dose during the T&E phase potentially could have extended to Q20W dosing. We will also explore baseline characteristics, including imaging biomarkers, that may predict whether patients could meet potential Q20W dosing criteria.

Conclusions : Patients always on extended faricimab dosing maintained vision and anatomic outcomes throughout 2 years. Additionally, > 50% of faricimab-treated patients potentially could have extended to Q20W, supporting dual angiopoietin-2/VEGF-A inhibition with faricimab as a novel therapeutic approach leading to durable efficacy.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.