Anne Fung, MD: Phase 3 ARCHWAY Top Line Results

Anne Fung, MD

With Genentech announcing positive top line results of Port Delivery System with ranibizumab (PDS), excitement around the potential wet age-related macular degeneration (nAMD) therapy has never been greater.

Top line results of the phase 3 ARCHWAY trial indicate the permanent refillable eye implant demonstrated non-inferior and equivalent efficacy on a 6-month refill protocol compared against patients receiving monthly ranibizumab injections.

“For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development with Genentech, in a statement. “We look forward to presenting detailed Archway results at future medical meetings and discussing these data with regulatory authorities, with the aim of bringing this new treatment option to patients as soon as possible.”

Including more than 400 patients, the phase 3 ARCHWAY trial had a primary endpoint of change in best-corrected visual acuity score from baseline at the average of week 36 and week 40. Secondary endpoints of the trial included safety, overall change in BCVA from baseline, and change from baseline in center point thickness over time.

Genentech noted full results of the ARCHWAY trial will be presented at a medical meeting later in 2020.

The statement from Genentech also noted the ongoing PORTAL study is assessing the long-term safety and tolerability for treatment of nAMD. Additionally, the PAGODA trial is assessing the use of a Port Delivery System for the treatment of diabetic macular edema.

In an effort to gain a greater insight into results of the phase 3 ARCHWAY trial, HCPLive® reached out to Anne Fung, MD, Global Development Lead for the Port Delivery System with ranibizumab at Genentech, to take part in Q&A.

HCPLive: What do these new topline results tell us about PDS with ranibizumab that we did not already know?

Fung: In this larger trial, we now have a more rigorous understanding of the efficacy and safety of PDS. In the Phase III Archway study, we studied patients with wet AMD who had the Port Delivery System with ranibizumab (PDS) refilled every six months, and we found that PDS delivered results that were not only not worse (non-inferior) but equivalent to monthly ranibizumab 0.5 mg injections, which is a standard of care for wet AMD. This is a significant milestone, and these positive top line results demonstrate the potential of PDS to offer reliable results for people living with neovascular AMD.

HCPLive: Based on these results, what kind of burden does PDS with ranibizumab alleviate for patients and clinicians?

Fung: Although current standards of care have significantly reduced vision loss from retinal conditions, they are associated with a high treatment burden. People with neovascular AMD may need eye injections with anti-VEGFs as often as once a month to achieve and maintain optimal vision outcomes. By continuously delivering medicine to the eye, PDS may decrease the need for frequent injections, potentially reducing the burden of treatment for both patients and clinicians.

HCPLive: Is there any indication of when we could see an application filed with the FDA for approval of this device?

Fung: While we don't have any specifics to share at this time, I can say that based on these results, Genentech does plan to discuss these results with health authorities around the world, including the US Food & Drug Administration, for consideration of regulatory approval for the treatment of nAMD.