Roche flashes new 16-week bispecific AMD data, setting eyes on pair of PhIII trials
While Roche awaits results from a pair of large Phase III trials, the Swiss pharma is touting another round of data from a smaller study on its wet macular degeneration (nAMD) bispecific antibody, faricimab.
Although new, the data largely confirm results Roche and its Genentech subsidiary flashed from the Phase II study two years ago, with both rounds suggesting that the experimental drug could be given once every 12 or 16 weeks, as opposed to the 4 weeks required for their long-running AMD blockbuster Lucentis.
“Traditionally, the standard of care is once every 4 weeks,” Carl Danzig, the study’s lead investigator, told Endpoints News. ”And there have been many real world studies that show treatment burden is real. Patients are not able to maintain their vision because they are not able to maintain monthly visits to the doctor.”
The impact of the new drug, though, may be limited, both economically and for patients. Roche is betting on faricimab, as Lucentis is set to come off patent protection in the US later this year and in Europe soon after. But the market for long-acting AMD drugs is now crowded. Since the study began in 2017, the market’s top selling wet-AMD drug, Regneron’s Eylea, has been approved for a 12-week dose. And late last year, the FDA approved Novartis’s Beovu for both 8-week and 12-week dosing regimens.
Is 16 weeks that much of an advantage over 12? Danzig acknowledged it’s less of a jump than moving from 4 weeks to 12, but pointed to the method by which these drugs are administered.
“I think for patients across the board, the fewer needles they get in their eye, the happier they are,” Danzig, who directs vitreo-retinal services at the Rand Eye institute, said. “It doesn’t sound like a huge leap but for that patient, one less needle in an eye means a lot.”
In the latest 52-week data, released as an abstract for the Association for Research in Vision and Ophthalmology, patients taking faricimab once every 12 weeks or once every 16 weeks showed “comparable” improvements in vision and anatomy. The lesions, for instance, shrunk 4.2, 5.4, and 4.5 mm for the 16 week faricimab, 12 week faricimab, and 4 week Lucentis arm, respectively. The leakage age shrunk 4.6, 5.6, and 5.3 mm.
Around two thirds of the patients showed no signs of disease progression at 24 weeks, or 12 weeks since the last initiation dose, meaning they could potentially have gone to the 16 week arm, Danzig said.
Even if faricimab fails to differentiate itself on efficacy or dosing, the drug will stand out scientifically. It is the first of the AMD antibodies to be bispecific, targeting both the long-trotted VEGF-pathway and angiopoietin-2, with the goal of stabilizing the leakage that causes vision loss from two different angles. The angiopoietin-2 pathway was briefly targeted experimentally by scientists for diabetic retinopathy, Danzig said, but has largely gone unexplored.
All eyes now are on two Phase III trials Roche began enrolling last year. Those will test faricimab directly against Eylea in around 1,300 patients, potentially setting up a regulatory decision in 2022 or 2023.