Outcomes by Faricimab Treatment Interval at Week 48 of TENAYA-LUCERNE Phase III Trials in Neovascular Age-Related Macular Degeneration

Abstract

Purpose: To assess the visual and anatomic outcomes by individualized treatment intervals at week 48 in patients with neovascular age-related macular degeneration (nAMD) treated with the dual angiopoietin-2/VEGF-A inhibitor faricimab in a post hoc analysis of pooled data from TENAYA/LUCERNE.

Design: TENAYA/LUCERNE (NCT03823287/NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled, noninferiority phase III trials.

Participants: Treatment-naïve patients ≥50 years of age with nAMD randomized to the faricimab up to every 16 weeks (Q16W; n = 665) arm.

Methods: Patients in the faricimab arm received 4 initial doses every 4 weeks through week 12. At weeks 20 and 24, they were assigned to fixed every 8 weeks (Q8W), every 12 weeks (Q12W), or every 16 weeks (Q16W) treatment intervals through week 60, based on prespecified central subfield thickness (CST) or best-corrected visual acuity (BCVA) disease activity criteria or presence of new macular hemorrhage, per investigator clinical examination. The primary analysis was at week 48.

Main outcome measures: Mean changes from baseline in BCVA and CST through week 48 by treatment interval group.

Results: At week 48, the proportion of faricimab-treated patients on each treatment interval was 45.3% (Q16W), 33.4% (Q12W), and 21.2% (Q8W). The baseline patient characteristics were well balanced across faricimab treatment intervals. However, patients assigned to treatment at Q16W and Q12W had less severe disease at baseline than patients assigned to Q8W. All patients showed sustained BCVA gains and CST reductions through week 48. Mean (95% confidence interval) change from baseline in BCVA was +7.9 letters (6.6 to 9.2), +4.0 letters (2.2 to 5.7), and +5.3 letters (2.4 to 8.2); and that in CST was -142.9 μm (-156.9 to -128.9), -112.5 μm (-131.0 to -94.1), and -165.1 μm (-193.8 to -136.4) for Q16W, Q12W, and Q8W, respectively.

Conclusions: Vision and anatomic improvements were achieved and maintained in all faricimab individualized treatment interval groups, with patients treated at longer intervals having more stable outcomes with fewer injections. The clinically relevant disease activity criteria based on vision or anatomy allowed treatment of patients with nAMD to be rapidly extended after the initial dosing phase while maintaining visual gains through week 48 of TENAYA/LUCERNE.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Angiopoietin-2 (Ang-2); Durability; Faricimab; Neovascular age-related macular degeneration; VEGF-A.