Efficacy, durability, and safety of faricimab in diabetic macular edema (DME): 1-year results from China subpopulation of phase 3 RHINE trial

Abstract

Purpose : The global RHINE trial demonstrated that dual angiopoietin-2/VEGF-A pathway inhibition with faricimab provides durable efficacy beyond current anti-VEGF therapies for DME. The China RHINE subpopulation included patients from mainland China, Hong Kong and Taiwan enrolled during the global (33 patients) and China extension phases (119 patients). Here we report 1-year efficacy, durability and safety results of faricimab in DME patients from the RHINE China subpopulation.

Methods : The RHINE trial (NCT03622593) was a randomized, double-masked, active comparator–controlled, phase 3 trial of intravitreal faricimab in treatment-naïve and previously anti-VEGF–treated patients with center-involving DME. Patients were randomized 1:1:1 to faricimab 6.0 mg Q8W after 6 initial Q4W doses; faricimab 6.0 mg per personalized treat-and-extend-based regimen (T&E) after 4 initial Q4W doses; or aflibercept 2.0 mg Q8W after 5 initial Q4W doses. The T&E regimen (Q4W up to Q16W) used prespecified BCVA/CST criteria to adjust dosing. The primary efficacy endpoint was BCVA change from baseline at 1 year, averaged over weeks 48/52/56. Other efficacy and safety endpoints assessed through week 56 are reported.

Results : In the China subpopulation, 152 patients were randomized (n=51 faricimab Q8W, n=49 faricimab T&E, n=52 aflibercept Q8W). Baseline characteristics were well balanced across arms. Adjusted mean BCVA gains from baseline at 1 year were 13.2, 11.5 and 9.2 ETDRS letters for faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively. These corresponded to adjusted mean letter differences (95% CI) of 4.0 (0.7, 7.2) and 2.3 (–0.9, 5.6) for faricimab Q8W and T&E compared to aflibercept, respectively. Adjusted mean CST change from baseline was –266, –257, and –217 µm at 1 year in the faricimab Q8W, T&E and aflibercept Q8W arms, respectively. These corresponded to adjusted mean differences (95% CI) of –49 (–82, –16) and –40 µm (–72, –7) respectively, for faricimab Q8W and T&E compared to aflibercept, respectively. The proportions of T&E-arm patients on ≥Q12W or Q16W dosing at week 52 were 75% and 50%, respectively. Faricimab was well tolerated, with an acceptable safety profile.

Conclusions : The efficacy, durability and safety of faricimab in the China subpopulation was consistent with the global population results.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.