Aura Biosciences has announced positive interim Phase II safety and efficacy data for belzupacap sarotalocan (bel-sar) as a first-line treatment for patients with early-stage choroidal melanoma with suprachoroidal administration.
The results showed a statistically significant reduction in tumour growth rate compared to each patient’s documented growth rate at study entry, and a 100% tumour control rate.
In addition, the visual acuity preservation rate was 88% in these cohorts, with the majority of patients being at high-risk for vision loss with tumours close to fovea or optic disk. The overall tolerability profile of bel-sar was generally favourable.
“The data presented today with an average of nine months of follow up for patients treated with three cycles of therapy, show an excellent response to the therapy with 89-100% tumour control. In addition, the safety profile to date has been favourable with only one patient losing visual acuity and no treatment-related SAEs or significant AEs, which is encouraging given that the majority of these patients had tumours close to the fovea or optic disk and would have likely experienced severe and irreversible vision loss with the current standard of care with radiotherapy,” said Dr Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear.
“These latest results strongly support the potential of bel-sar to be used as a first-line treatment option for patients with early-stage choroidal melanoma.”
The study results were presented at the Macula Society 46th Annual Meeting held in Miami, FL.
Dr Cadmus Rich, Chief Medical Officer of Aura Biosciences, said: “Collectively, we believe these interim data provide strong confidence to support the launch of a global Phase III trial which is on track to begin enrolment this year.”