Choroidal melanoma treatment continues to show encouraging results at 9 months
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Belzupacap sarotalocan via suprachoroidal administration demonstrated positive interim phase 2 safety and efficacy data at an average of 9 months follow-up for the treatment of early-stage choroidal melanoma.
In the ongoing trial, belzupacap sarotalocan (bel-sar), also known as AU-011, is being evaluated for tumor control and visual acuity preservation after up to three cycles of treatment by single and multiple ascending doses, according to a press release from Aura Biosciences. Twenty patients have been enrolled in the trial, and in cohorts 5 and 6, there was a statistically significant reduction of –0.289 mm per year in tumor growth rate (P ≤ .0001) compared with each patient’s documented growth rate at entry and a 100% tumor control rate.
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Additionally, the visual acuity preservation rate was 88% in cohorts 5 and 6, with most patients considered as high risk for vision loss.
“The safety profile to date has been favorable with only one patient losing visual acuity and no treatment-related [serious adverse events] or significant [adverse events], which is encouraging given that the majority of these patients had tumors close to the fovea or optic disc and would have likely experienced severe and irreversible vision loss with the current standard of care with radiotherapy,” Ivana K. Kim, MD, director of the Ocular Melanoma Center at Massachusetts Eye and Ear, said in the release.
A global phase 3 trial continuing the investigation of bel-sar is expected to begin enrollment later this year, according to the release.
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