STAIRWAY Analysis Details Clinical Effects of Faricimab Use for nAMD

Carl Danzig, MD

New research is shedding additional light on the clinical impact faricimab on angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF) from the phase 2 STAIRWAY trial.

The research, which was presented as part of the first release of ARVO 2020 data on ARVOLearn, outlines the sustained anatomic and visual outcomes experienced with faricimab at 16-week and 12-week intervals compared to ranibizumab every 4 weeks.

“Faricimab was well-tolerated and no new safety signals were identified,” said Carl Danzig, MD, director of Vitreo-Retinal Services at the Rand Eye Institute, during his presentation on ARVOLearn.

The first bispecific antibody designed for intraocular use, faricimab has the ability to simultaneously bind and neutralize Ang-2 and VEGF-A and potential to address under-treatment of neovascular age-related macular degeneration (nAMD). While STAIRWAY evaluated the agent’s efficacy and safety profile compared to ranibizumab, the current study sought to assess the anatomic and visual outcomes associated with faricimab use.

Briefly, the 52-week, multicenter, phase 2 STAIRWAY trial was designed to assess 2 extended dosing regimens of faricimab 6 mg compared to ranibizumab 0.5 mg administered every 4 weeks. A total of 76 patients were randomized in a 2:2:1 ratio to 16-week faricimab, 12-week faricimab, or ranibizumab.

Results of the original STAIRWAY trial suggested patients receiving faricimab could result in comparable improvements in visual acuity and reductions to central retina thickness as ranibizumab with less frequent injections.

Results of the current study indicated improvements in best-correct visual acuity, reductions in central subfield thickness on spectral-domain optical coherence tomography (SD-OCT), choroidal neovascularization (CNV) lesion size, and area of leakage on fluorescein angiography with faricimab on a 16-week or 12-week dosing regimen were comparable to that achieved with ranibizumab. Additionally, investigators did not observe any new or unexpected safety signals in the analysis.

Results suggest changes from baseline in total lesion area were -4.2, -5.4, and -4.5 mm2 among patients in the faricimab 16-week group, faricimab 12-week group, and the ranibizumab group, respectively. In regard to changes from baseline in CNV component area, results suggest change was —4.3, –5.6, and –4.8 mm2, for patients in the 16-week faricimab group, 12-week faricimab group, and ranibizumab group, respectively.

In his presentation, Danzig noted the TENAYA and LUCERNE trials, which are both global phase 3 studies, are investigating efficacy, safety, and durability of faricimab in patients with nAMD. Both of these studies are designed to compare faricimab 6.0 mg with dosing intervals up to 16 weeks against aflibercept 2.0 mg every 8 weeks—the trial will include an estimated 640 patients 50 years of age and older who are treatment-naive.

The primary objective of these phase 3 trials is the mean best-corrected visual acuity change form baseline at week 48 as an average of weeks 40, 44, and 48. The secondary endpoints of these trials is the proportion of patients on treatment intervals of 8-, 12-, and 16-weeks.

This study, “Clinical Effects of Blocking Ang-2 and VEGF with Faricimab in the Phase 2 STAIRWAY Trial,” was published in ARVOLearn.