Innovent Biologics’ eye disease prospect has matched Bayer and Regeneron’s Eylea in a phase 3 study, teeing up filings for Chinese approval of a molecule that could reduce maintenance dose frequency.
The Star study enrolled 600 people in China with neovascular age-related macular degeneration (nAMD). Half the patients received efdamrofusp alfa, Innovent’s investigational VEGFR/CR1 fusion protein. The other patients received a 2-mg dose of aflibercept, the anti-VEGF agent Bayer and Regeneron sell as Eylea. Everyone received three loading doses every four weeks before switching to maintenance dosing.
At Week 52, the mean change in BCVA—a measure of vision clarity—was 10.37 ETDRS letters on the study drug and 10.11 ETDRS letters on Eylea. The result showed efdamrofusp is as effective as Eylea at improving vision, achieving the trial’s primary endpoint.
Efdamrofusp matched Eylea despite typically being given less frequently. Patients on Eylea received the drug every eight weeks during the study’s maintenance period. Physicians assigned patients in the efdamrofusp cohort to receive the study drug every eight, 12 or 16 weeks based on assessments of disease activity at weeks 16 and 20.
Related
Almost 73% of patients received efdamrofusp every 16 weeks during the maintenance period. The other patients were fairly evenly split between people who received the study drug every eight and 12 weeks.
Innovent compared the results to data from two trials of Roche’s bispecific nAMD drug Vabysmo. While cross-trial comparisons can be unreliable, data on the proportion of patients achieving dosing intervals of 12 or 16 weeks favor efdamrofusp. About 45% of patients received Vabysmo every 16 weeks in a pair of phase 3 trials.
Roche has identified China, where it sells Vabysmo as Luoshijia, as a major market for the nAMD drug. The Swiss drugmaker committed about $280 million last year to building a production plant in China that will mainly make the nAMD drug.
Innovent’s statement lacked a comparison to data on the 8-mg dose of aflibercept, which won approval in China last year. Bayer and Regeneron’s trial randomized patients to receive high-dose Eylea every eight, 12 or 16 weeks. At Week 48, 77% of patients randomized to the 16-week interval remained (PDF) on the regimen. The other patients had dropped to an eight- or 12-week dosing interval.
Related
With Bayer and Roche already marketing nAMD drugs in China, Innovent will need to win market share from incumbent drugs if authorities approve efdamrofusp. The biotech has identified macular atrophy as a potential point of difference. Because efdamrofusp targets the complement system, researchers have hypothesized that it may suppress damage associated with long-term use of anti-VEGF agents.
The incidence of macular atrophy in the efdamrofusp group was 1.5%, compared to 2.9% on aflibercept. Innovent also reported a numerically higher incidence of macular atrophy on aflibercept than its drug candidate in a phase 2 trial.
