Phase 2 data promising for choroidal melanoma therapy
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CHICAGO — AU-011 helped preserve vision in patients with early-stage choroidal melanoma, according to a study presented at the American Academy of Ophthalmology meeting.
Ivana K. Kim, MD, MBA, and colleagues enrolled 20 patients in an ongoing phase 2 trial of AU-011 (belzupacap sarotalocan, Aura Biosciences), delivered via suprachoroidal administration, according to a company press release. The trial is assessing the safety and preliminary efficacy of single and multiple ascending doses of belzupacap sarotalocan for up to three cycles of treatment. It included three single-dose cohorts and three multiple-dose cohorts.
Patients in multiple-dose cohorts 5 and 6 had active tumor growth at study entry. Researchers evaluated preliminary efficacy in these patients through tumor growth rate, tumor control and visual acuity preservation.
At an average of 6 months of follow-up, patients in cohorts 5 and 6 showed a reduction in tumor growth rate compared with each patient’s documented growth rate at study entry (P = .0007). The tumor control rate was 88.9%.
Additionally, the visual acuity preservation rate in these cohorts was 88.9%, even though a majority of patients were at high risk for vision loss.
Treatment-related adverse events were mostly mild and resolved without sequalae.
“Interim data showed a statistically significant reduction in tumor growth rate and a robust tumor control response with a high rate of visual acuity preservation at the therapeutic regimen,” Kim said in the release. “Belzupacap sarotalocan offers a favorable safety profile supporting the potential to become the first vision-preserving treatment for early-stage choroidal melanoma, where patients have had to rely on radiotherapy for the last few decades.”
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Kim IK. A phase 2 trial of belzupacap sarotalocan (AU-011) a first-in-class targeted therapy for choroidal melanoma via suprachoroidal administration. Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
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