STAIRWAY trial shows sustained efficacy of faricimab
Simultaneous neutralization of Ang-2 and VEGF-A with faricimab has the potential to reduce vascular destabilization in age-related macular degeneration, achieving sustained efficacy with a significantly lower frequency of administration as compared with ranibizumab.
The results of the STAIRWAY phase 2 multicenter controlled trial, presented at the virtual Association for Research in Vision and Ophthalmology meeting, showed promising results, according to one presenter.
Ang-2 is a pro-inflammatory mediator that acts synergistically with VEGF to drive vascular instability.
“Faricimab is the first bispecific antibody for intraocular use engineered to bind and neutralize Ang-2 and VEGF at the same time, with high specificity and potency, promoting vascular stability by reducing leakage, neovascularization and inflammation,” Carl Danzig, MD, said.
In the STAIRWAY trial, the efficacy of faricimab administered at 12- and 16-week intervals was evaluated against ranibizumab every 4 weeks. In the faricimab group, four initial 4-week (Q4W) doses were administered up to week 12, followed by 12 weeks without any doses. Patients were then divided into a 12-week (Q12W) fixed subgroup and a 16-week (Q16W) flex subgroup. At week 24 of the trial, patients in the Q16W flex subgroup were examined and continued with the same Q16W interval if no disease activity was found, or they were switched to Q12W in case of active disease.
“At week 24, 3 months after the last loading dose, 65% of faricimab-treated patients were disease activity-free. In the Q16W flex subgroup, 61% had no disease activity and were treated Q16W through to week 52. All other patients were treated Q12W. BCVA gains over time for Q16W and Q12W were fully maintained at week 52 and comparable to Q4W ranibizumab treatment,” Danzig said.
The drug was well tolerated, and no new safety signals were identified.
Two large global phase 3 trials, TENAYA and LUCERNE, are currently investigating the efficacy, safety and durability of faricimab in comparison with aflibercept administered every 8 weeks. – by Michela Cimberle
Danzig C. Clinical effects of blocking Ang-2 and VEGF with faricimab in the phase 2 STAIRWAY trial. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 6, 2020 (virtual meeting).
Disclosure: Danzig reports he is a consultant to Genentech, Ocular Therapeutix, Novartis and Oxurion.