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Early study results positive for AU-011 in patients with choroidal melanoma

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Amy Schefler

VANCOUVER, British Columbia — A phase 1b/2 clinical trial of AU-011, a light-activated, vision-sparing, tumor cell selective therapy for patients with choroidal melanoma, showed the treatment was safe and resulted in no vision loss for up to 12 months, according to a speaker here.

“AU-011 appears to be safe in early trials and is well tolerated. There is inflammation. It seems to start within the tumor and then enlarge, and is probably related to tumor necrosis and may be beneficial and is manageable. Vision in these patients appears to be preserved up to 12 months after treatment, regardless of the proximity of the tumor to the fovea,” Amy C. Schefler, MD, said at the American Society of Retina Specialists annual meeting.

The 2-year, prospective, multicenter, open-label clinical trial is evaluating the safety and efficacy of single and multiple ascending doses of AU-011 (Aura Biosciences) in patients with choroidal melanoma. All tumors are limited to less than 16 mm in base diameter, Schefler said.

The study was designed to assess several parameters related to the therapy, primarily the drug dose, the number of weekly treatments and the number of laser administrations associated with those treatments. The current group being treated receives 80 µg three times weekly. To date, 22 patients have been treated, and there have been no serious adverse events, she said.

All patients who have been followed for 6 months or longer have had a final vision at last follow-up within one letter of their baseline, she said.

“The therapy appears to be efficacious, with reduction in tumor thickness, in both the low-dose subtherapeutic groups and the multiple-dose cohorts, with vision preservation regardless,” Schefler said. – by Robert Linnehan

Reference:

Schefler AC. 6-month results of a phase 1b-2 prospective multicenter clinical trial of a novel targeted therapy (AU-011) for the treatment of choroidal melanoma. Presented at: American Society of Retina Specialists annual meeting; July 20-25, 2018; Vancouver, British Columbia.

Disclosure: Schefler reports she is an investigator for Aura Biosciences but did not receive consultant fees.