Innovent Biologics Inc. (IVBXF,1801.HK) announced that the Phase 3 STAR clinical study of efdamrofusp alfa injection (IBI302), a recombinant human VEGFR/CR1 fusion protein, in Chinese patients with neovascular age-related macular degeneration (nAMD) has successfully met its 52-week primary endpoint.
The study demonstrated that efdamrofusp alfa was non-inferior to aflibercept in improving vision, while also offering the clinical advantage of extended 16-week dosing intervals and showing potential to reduce the risk of macular atrophy (MA).
STAR enrolled 600 participants randomized 1:1 to receive either IBI302 8 mg or aflibercept 2 mg. Both groups received three loading doses every four weeks. Afterward, patients in the IBI302 group were treated at Q16W, Q12W, or Q8W intervals based on disease activity, while the aflibercept group continued at Q8W intervals. The primary endpoint was the change in best corrected visual acuity (BCVA) at Week 52.
Results showed that IBI302 achieved a mean BCVA improvement of 10.37 ETDRS letters, comparable to aflibercept's 10.11 letters. Importantly, 86% of patients in the IBI302 group maintained dosing intervals of Q12W or longer, with 72.8% reaching Q16W. Nearly 95% of those on Q12W/Q16W dosing maintained their schedule without retreatment, and over half showed no disease activity at Week 24, suggesting potential for even longer intervals up to Q20W.
Anatomical efficacy endpoints, including central subfield thickness reduction and fluid resolution, were similar between groups. Notably, the incidence of macular atrophy was 1.5% in the IBI302 group compared to 2.9% in the aflibercept group, indicating a 50% lower risk with IBI302.
Safety outcomes were favorable, with adverse events comparable between groups. Most ocular events were mild to moderate and resolved with observation or routine management.
This pivotal study highlights efdamrofusp alfa's potential to not only match current standards of care in vision improvement but also to significantly reduce treatment burden and lower the risk of macular atrophy in patients with nAMD.
Innovent Biologics on the Hong Kong Stock Exchange closed at HK$79.20, up HK$1.70 or 2.19%.
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