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Early results of new therapy for choroidal melanoma show promise

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Jay S. Duker

WAILEA, Hawaii — The light-activated AU-011 agent represents the first potential new therapy for choroidal melanoma in many decades, according to a speaker here.

Overall, the 5-year metastatic rate for all [choroidal melanoma] tumors is about 35%, Jay S. Duker, MD, said at Retina 2018, and current treatment is “not benign.”

Plaque brachytherapy, in and of itself, has morbidity, and the radiation itself has visual consequences, Duker said.

“Wouldn’t it be great if we had something that gave us local tumor control, equivalent protection against metastases, but we could preserve vision, and do it in the office and have no anterior segment complications?” Duker asked.

AU-011 is a viral nanoparticle conjugate delivered by intravitreal injection, which targets tumor cells in the choroid and then is activated by ophthalmic laser to disrupt the tumor cell membrane, leading to necrosis.

Initial phase 1b/2a dose escalating results in six patients are promising, showing good safety and a “hint of efficacy,” Duker said. There were no serious or severe adverse events.

“The adverse events that were seen were all intraocular adverse events and were the kind of things that you would expect if you were injecting a viral-like particle into the eye and then causing the local destruction of tumor cells. The number one thing was inflammation,” Duker said.

Adverse events through the 6-month visit were mild to moderate and manageable: anterior chamber inflammation, posterior inflammation, increased IOP, keratic precipitates, decreased vision and linear scotoma.

Regarding efficacy, “You don’t expect to see much efficacy because you are undertreating these eyes with one injection, not three, and at a lower dose, he said.

A phase 2 multicenter trial is underway, with this next cohort of patients dosed at a higher amount, Duker said. – by Patricia Nale, ELS

Reference:

Duker JS. Novel management of choroidal melanoma: AU011. Presented at: Retina 2018; Jan. 14-19, 2018; Wailea, Hawaii.

Disclosure: Duker reports he is a consultant for and is on the data safety monitoring board for Aura Biosciences.