Biosimilar QL1207 demonstrates similar safety and efficacy as aflibercept in AMD treatment trial
The randomized, double-blind, phase 3 trial comparing the biosimilar QL1207 to the reference drug aflibercept for the treatment of neovascular age-related macular degeneration (nAMD) demonstrated equivalent efficacy between the treatments.
The study enrolled 366 patients with untreated subfoveal choroidal neovascularization secondary to nAMD and a baseline best-corrected visual acuity (BCVA) letter score of 73-34. Patients were randomly assigned to receive intravitreous injections of either QL1207 or aflibercept every 4 weeks for the initial 3 months, followed by injections every 8 weeks until week 48. Stratification was based on baseline BCVA, categorized as ≥45 letters or<45 letters.
The primary endpoint of the study was the change in BCVA from baseline at week 12, with an equivalence margin set at ± 5 letters. There were BCVA changes of -1.1 letters (95% confidence interval -3.0 to 0.7; P = 0.2275) between the QL1207 and aflibercept groups, remaining within the predefined equivalence margin.
Analysis of safety parameters, including treatment-emergent adverse events (TEAE) and serious TEAE, showed comparable incidences between the QL1207 and aflibercept groups (TEAE: QL1207 71.4% vs aflibercept 71.8%; serious TEAE: QL1207 14.1% vs aflibercept 12.7%).
Additional assessments, including anti-drug antibody presence, pharmacokinetic profiles, and plasma vascular endothelial growth factor concentrations, demonstrated similarities between the QL1207 and aflibercept groups.
Reference
Li B, Fan K, Zhang T, et al. Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial. Ophthalmol Ther. 2023;doi: 10.1007/s40123-023-00836-4. Epub ahead of print. PMID: 37987893.
