Kodiak Sciences released new topline results from a pivotal Phase III trial investigating the recently discontinued tarcocimab tedromer in patients with macular oedema due to retinal vein occlusion (RVO).
The newly released one-year data showed that tarcocimab demonstrated matched efficacy with differentiated durability versus its head-to-head comparator Eylea (aflibercept), which is co-developed by Regeneron and Bayer.
Additionally, 47% of patients treated with four initiating doses of tarcocimab in the first half year did not require additional injections in the second part of the year. For comparison, 37% of patients treated with six initiating monthly doses of Eylea remained injection-free in the second half of the study.
According to Kodiak’s press release, safety and tolerability were comparable between the two drugs. However, the intraocular inflammation (IOI) rate was observed in 2.5% of patients treated with tarcocimab compared to 0.7% in the Eylea cohort.
While the overall number of cataracts were low in the one-year follow-up, 4.9% of patients treated with tarcocimab reported cataract compared to 2.8% in the Eylea cohort.
Tarcocimab is a vascular endothelial growth factor (VEGF) inhibitor developed using Kodiak’s antibody biopolymer conjugate (ABC) platform.
BEACON trial design
The double-masked, active comparator-controlled Phase III trial (NCT04592419) enrolled 568 treatment-naïve patients with vision loss and macular oedema due to RVO. The patient population included both branch (BRVO) and central (CRVO) subtypes of RVO.
Participants were equally randomised into the two treatment arms that investigated a 5mg dose of tarcocimab and a 2mg dose of Eylea.
In the first half of the study, tarcocimab was administered on a fixed eight-week dosing regimen following two monthly loading doses. Eylea was administered on a fixed monthly dosing regimen as per the drug’s label.
In the second portion of the trial, tarcocimab and Eylea were tested head-to-head according to a pro re nata (PRN) protocol, meaning patients were treated only when the disease was reactivated according to the predefined criteria.
Tarcocimab’s flop
Despite positive data in RVO, tarcocimab was not as successful in diabetic macular oedema (DMO). In July, Kodiak announced that tarcocimab failed to achieve the primary endpoint in two identical Phase III GLEAM and GLIMMER trials.
Tarcocimab failed to show non-inferior visual gains compared to Eylea. Additionally, an increase in cataracts was observed over time in the tarcocimab cohort. According to Kodiak, this contributed meaningfully to the failure of the trial, resulting in the discontinuation of further development.
Kodiak is yet to announce one-year primary endpoint data from another Phase III trial in non-proliferative diabetic retinopathy. According to the recent statement, data from the GLOW trial will be released in Q4 2023.
Kodiak’s CEO Dr Victor Perlroth said: “The GLOW data combined with these one-year results from BEACON should provide us additional insights as we evaluate future options for our ABC Platform and platform-derived medicines."
