Injection Significantly Reduces in Choroidal Melanoma Tumor Growth

Adults with choroidal melanoma (CM) treated with AU-011 had a significant reduction in tumor growth after 1 year of treatment, according to researchers. Data from the Phase 1b/2 trial was presented by Carol Shields, MD, at the American Academy of Ophthalmology 2021 meeting, held in New Orleans from November 12-15.

The study included 15 adults, a subset from a larger study comprised of 56 participants, with CM who were treated with 3 weekly doses of the highest regimen of intravitreal AU-011 and laser. Study participants were treated with up to 2 cycles. They were then evaluated for efficacy at 12 months. 

Researchers reported a statistically significant reduction in tumor growth rate over 1 year after treatment (-0.445 mm/year, P =.018). In addition, 60% of patients (9/15) achieved tumor control at 12 months. Most patients (73%) maintained visual acuity (defined as a loss of best corrected visual acuity of fewer than 15 letters) at 12 months. 

The majority of patients (14/15) were at high risk for vision loss with radiotherapy (tumors ≤3 mm from the foveola). However, among all 56 treated patients, serious adverse events were rare, with only 2 patients with juxtafoveal tumors developing treatment-related vision loss. In general, adverse events, such as intraocular inflammation and intraocular pressure increase, were transient and treatable in most patients. 

“AU-011 may offer a vision-preserving therapy for first-line treatment of CM,” concluded the researchers. 

Reference

Shields CL. A Phase 1b/2 trial of AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA054.