Pegcetacoplan Shifts Distribution Across Lesion Growth Quartiles In GA Treatment
Evidence of pegcetacoplan treatment effect observed in the distribution of patients across quartiles in both OAKS and DERBY.
Roger Goldberg MD, MBA
New findings suggest pegcetacoplan shifts the distribution across lesion growth quartiles in assessment of the progression of geographic atrophy (GA) using 12-month data from OAKS and DERBY.
Investigators observed data show a similar treatment effect observed in the primary analysis of these 2 trials.
“This analysis provides additional data on factors that may impact lesion growth; with further research, these findings may aid in identifying populations that may have a greater response to pegcetacoplan,” wrote lead study author Roger Goldberg MD, MBA, Vitreoretinal Surgeon, Bay Area Retina Associates.
These findings were presented at the American Society of Retina Specialists 40th Annual Scientific Meeting.
The phase 3 randomized, double-masked OAKS and DERBY assessed the efficacy and safety of investigational intravitreal pegcetacoplan for GA treatment, secondary to age-related macular degeneration. A detailed analysis by category of change in GA lesion size was reported in eyes treated with pegcetacoplan or sham.
Both studies had the primary endpoint of change in GA lesion size via fundus autofluorescence imaging from baseline to month 12. The patients were pooled across study arms and assigned to quartiles defined by the amount of lesion growth (mm2) over 12 months. The quartiles were separated into:
- Quartile (Q)1 (slow progressors; OAKS: <0.93, DERBY: <1.025)
- Q2 (OAKS: ≥0.93 – <1.48, DERBY: ≥1.025 – <1.62)
- Q3 (OAKS: ≥1.48 – <2.27, DERBY: ≥1.62 – <2.45)
- Q4 (OAKS: ≥2.27; DERBY: ≥2.45).
Inclusion in the analysis was restricted to those with a month 12 lesion growth measurement. Data show OAKS and DERBY had 494 and 461 respective patients included in the analysis.
Investigators reported that in both OAKS and DERBY, evidence of a treatment effect of pegcetacoplan was seen in the distribution of the included patients across the quartiles. They found the slowest progression quartile (Q1) had a higher proportion of patients treated with pegcetacoplan monthly (39% and 36%) or every other month (36% and 35%), compared to those in the sham cohort (25% and 30%).
Moreover, data show relatively more sham patients (42% and 37%) in the fastest growing quartile (Q4) compared to patients treated with pegcetacoplan monthly (27% and 29%) or every other month (31% and 34%), in OAKS and DERBY, respectively.
Baseline study eye lesion size was larger in the fast progressor group compared to the slow progressor group (OAKS: 9.5 mm2 versus 7.1 mm2; DERBY, 9.5mm2 vs 6.5 mm2, respectively).
Additionally, the fast progressor group had a higher proportion of individuals with extrafoveal study eye lesion location, multifocal study eye GA, bilateral GA, double-layer sign present in the study eye and pseudodrusen present in the study eye, according to investigators.
The fast progression group further had a lower proportion of patients with >20 SE intermediate or large drusen or choroidal neovascularization in the fellow eye, investigators noted.
“Assessment of Geographic Atrophy Lesion Progression in the Phase 3 OAKS and DERBY Trials,” was presented at ASRS 2022.
