Roche expands its PhIII program for Eylea rival as long-acting data back its blockbuster contender faricimab

Roche’s Genentech has notched another success on its way to challenging Regeneron — as well as the other Big Pharma contender Novartis — for the blockbuster crown now worn by Eylea.

Researchers at the big sub say that their bispecific Ang-2/VEGF drug faricimab (you once knew it as RG7716) came up with an improved profile over their franchise player Lucentis as a long-acting drug for wet AMD. And they scored on long acting 16-week data, while Regeneron $REGN and Novartis $NVS have been duking it out over the 12-week niche.

Here’s the latest data from their Phase II STAIRWAY study, which dosed faricimab 6.0 mg every 16 weeks or every 12 weeks, compared to ranibizumab (Lucentis) 0.5 mg every four weeks:

At week 24 (three months after the last of four loading doses), patients randomized to faricimab every 16 weeks were switched to 12-week dosing if they were shown to have active disease, per pre-defined criteria. At week 24, 65 percent (n=36/55) of people treated with faricimab had no active disease, highlighting the potential of 16-week dosing in nearly two-thirds of patients. Initial vision gains, as measured by Best Corrected Visual Acuity (BCVA), were fully maintained through to week 52 with 16- and 12-week dosing regimens. People treated with faricimab dosed every 16 weeks experienced a mean improvement of 11.4 chart letters from baseline, compared to 10.1 letters in patients treated with faricimab dosed every 12 weeks and 9.6 letters in patients treated with ranibizumab (Lucentis) 0.5 mg dosed every four weeks. 

Eylea has been the master of this market, giving Regeneron the lucrative franchise market it needs to build the company’s pipeline and new product offerings. Novartis, meanwhile, has been making a mark with brolucizumab (RTH258), which it has presented as a major late-stage contender.

For Regeneron, Eylea remains worthy of a vigorous defense, even though its own next-gen drug failed to make a mark. Researchers for the company have been fighting back against its major league rivals with their own longterm data aimed at protecting its rep and billions of annual revenue.

Roche, meanwhile, is pushing ahead into late-stage work — with Phase IIIs that will take considerable time for a readout. They’re already deep into diabetic macular edema and now plan to add wet AMD to the late-stage roster.

Regeneron has plenty of support for its aggressive defense strategy, though. Leerink’s Geoffrey Porges, in particular, has waded into the melee, ready to defend the title that Regeneron won early. But this fight has a ways to go, with rivals ready to duke it out in ways that are likely to play out in patients’ favor — one way or another.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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