Tumor control, visual acuity preservation observed with AU-011 for choroidal melanoma
A phase 1b/2 open-label clinical trial of patients with choroidal melanoma treated with AU-011 showed a statistically significant reduction in tumor growth rate and favorable preliminary vision, according to a speaker.
“AU-011 has the potential to be the first targeted therapy for the treatment of small choroidal melanoma and indeterminate lesions,” Carol L. Shields, MD, said at Retina Subspecialty Day at the virtual American Academy of Ophthalmology meeting.
Shields presented the interim results of 56 patients treated with intravitreal administration of AU-011 (Aura Biosciences), a novel nanoparticle, in a phase 1b/2 open-label clinical trial and the initial findings of a phase 2 suprachoroidal trial that was initiated earlier this year.
In the phase 1b/2 trial, participants received intravitreal administration of AU-011 at doses of 20 µg, 40 µg or 80 µg followed by laser activation. Single-dose, multiple-dose and expansion-dose cohorts have been completed, she said.
Vision was preserved in 91% of study participants. Vison was also preserved in 91% of participants who were phase 3 eligible.
Fifty-five percent of subjects experienced tumor control at the last visit, including participants who were underdosed in the single- and multiple-dose cohorts. In participants who were phase 3 eligible, 68% experienced control, and 80% who experienced control were phase 3 eligible and received two cycles, Shields said.
After treatment, tumor growth rate was reduced from 0.7 mm a year to nearly zero, which was a statistically significant reduction.
The next step is to evaluate suprachoroidal injections of AU-011. Suprachoroidal injections can optimize therapeutic index, increase the number of treatable patients and optimize treatment parameters. Researchers are evaluating this in the phase 2 study, which has completed three single-dose cohorts of 20 µg, 40 µg with a single laser activation or 40 µg with two laser activations.
“We so far have had a favorable safety profile and anticipate completing enrollment of the multiple-dose cohorts by January 2021,” Shields said.
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Shields CL. AU-011, a targeted therapy for primary treatment of choroidal melanoma (CM) via intravitreal (IVT) and suprachoroidal (SC) administration. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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