Faricimab Shows Potential for 16-Week Dosing

Initial data presented from Genentech’s STAIRWAY study.

The first data coming from Genentech’s phase 2 STAIRWAY trial using the bispecific anti-VEGF/anti-Ang2 faricimab (formerly called RG7716) in wet AMD show early potential for every 16-week dosing in treatment-naïve patients. At 24 weeks into the study, 36 of 55 patients (65%) had no active disease 12 weeks after their last faricimab loading dose, leading to the study’s conclusion that those patients were in no immediate need of retreatment.

The potential of more durable every 16-week dosing is considered important because other investigational drugs for wet AMD and the already approved aflibercept (Eylea; Regeneron) have shown efficacy at 12-week retreatment intervals.

The data were presented at the recent Retina Society annual meeting by Pravin U. Dugel, MD, of Retinal Consultants of Arizona, who also reported the first clinical results from Genentech’s AVENUE trial for faricimab. The AVENUE study is a 273-patient, phase 2 trial comparing faricimab, ranibizumab, and a faricimab/ranibizumab combination in treatment-naïve wet AMD patients. In this 5-arm study, a 1.5 mg dose of faricimab given every 4 weeks demonstrated the best vision gain at +9.1 letters at 36 weeks.

All 5 arms showed significant reductions in central subfield thickness, with the faricimab/ranibizumab combination arm demonstrating the largest reduction at -185 microns. In commenting on the overall data, Dr. Dugel said the bispecific nature of faricimab was a potential benefit, as “there are signs that the Ang-2 suppression has a vascular stabilization effect.”

Data were previously released from a third faricimab phase 2 trial, the 229-patient BOULEVARD study. That trial met its primary endpoint, as faricimab demonstrated statistically significant BCVA gains over ranibizumab at week 24 in anti-VEGF treatment-naïve patients with DME.