First time results of the Phase 3 BEACON trial: Torcocimab (KSI-301) vs Aflibercept for RVO patients

Matt Starr, MD
Assistant Professor of Ophthalmology
Mayo Clinic
RETINA RoundUp Assistant Editor

At Euretina last week in Hamburg, Germany, Dr. Ashard Khanani presented first time data from Kodiak’s pivotal phase 3 BEACON trial on the novel agent KSI-301 from Kodiak Sciences, or tarcocimab. Tarcocimab is a novel antibody biopolymer conjugate (ABC) agent aimed to have increased efficacy compared to current anti-VEGF agents. The polymer is a clear, high molecular weight phosphorylchlorine polymer meant to shield the antibody so that it can focus on the specific target with perhaps with better efficacy. This agent has a weight of 950 kD compared to 115 kD of aflibercept.

This study was a phase 3 noninferiorty study comparing every 2 months tarcocimab (after two loading doses) vs monthly aflibercept in patients with retinal vein occlusions. Two analyses were performed, those with branch retinal vein occlusions and then all retinal vein occlusions combined.

This study met its primary endpoint, showing noninferiorty of Q8W tarcocimab to Q4W aflibercept in both analyses (BRVO patients and all RVOs combined). Tarcocimab led to improved BCVA and CST comparably to aflibercept in both the initial loading dose phases and in the maintenance phases up to 24 weeks.

Tarcocimab is the first anti-VEGF to demonstrate noninferiority to current therapy with fewer doses. Importantly it was well tolerated in this study with good safety data. Of note, 1.4% of patients developed uveitis and 0.4% (1 patient) developed vitritis with no vision loss. Dr. Khanani noted during the Q&A that this large polymer allows for a large anti-VEGF load to be given in a disease that often has a large VEGF burden, offering hope for patients who require frequent injections to potentially receive fewer injections with similar vision and anatomic outcomes.