Faricimab treatment outcomes with extended dosing and potential for Q20W intervals in DME: post hoc analysis of the 96-week phase 3 YOSEMITE/RHINE trials

Abstract

Purpose : Dual angiopoietin-2 and vascular endothelial growth factor (VEGF)-A pathway inhibition with faricimab may extend treatment durability beyond current anti-VEGF therapies for diabetic macular edema (DME). In the phase 3 YOSEMITE/RHINE trial, a personalized treat-and-extend–based regimen (T&E) evaluated the potential of faricimab to reduce treatment burden while maintaining clinical efficacy in patients with DME. In this post hoc analysis, we assessed the efficacy of extended faricimab dosing (every 12 weeks [Q12W] to Q16W) and evaluated how many patients potentially could have extended to Q20W dosing.

Methods : In YOSEMITE/RHINE (NCT03622580/NCT03622593), patients were randomized 1:1:1 to faricimab 6.0 mg T&E after ≥ 4 initial Q4W doses, faricimab 6.0 mg Q8W after 6 initial Q4W doses, or aflibercept 2.0 mg Q8W after 5 initial Q4W doses through week 100 (N = 1891). In the faricimab T&E arm, treatment intervals were adjusted (Q4W–Q16W) based on prespecified central subfield thickness (CST) and best-corrected visual acuity (BCVA) criteria. Vision and CST outcomes were evaluated for T&E patients ending the study on Q12W and Q16W. Extension criteria were also applied to T&E patients on Q16W to assess if they met criteria for Q20W extension.

Results : Among T&E patients at week 96 (N = 557), 62% achieved Q16W dosing and 78% achieved ≥ Q12W dosing. Mean (SD) BCVA at week 96 for T&E patients ending the study on Q12W and Q16W was 73.6 (9.9) and 75.4 (10.9) letters, respectively, and 73.3 (11.5) letters for T&E arm overall. Mean (SD) CST at week 96 for T&E patients ending on Q12W, Q16W, and for T&E arm overall was 278.1 µm (77.4), 258.3 µm (37.8), and 275.7 µm (75.3), respectively (Figure). Among T&E patients with dosing interval data up to week 48 (N = 598), 56% met extension criteria and potentially could have extended to Q20W by end of study. The results of a new exploratory analysis into baseline characteristics of patients on extended intervals will also be presented.

Conclusions : DME patients extended to faricimab Q12W and Q16W dosing demonstrated robust and stable vision and anatomic improvements through year 2. Among T&E patients, > 50% potentially could have achieved Q20W dosing, supporting faricimab as a novel therapeutic approach with durable efficacy.

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