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Photoimmunotherapy offered in clinical trial for recurrent head and neck cancer

Oct. 14, 2021, 9:36 AM

Twenty-four hours after the administration of the study drug, catheters are inserted into the tumor and lasers emitting a wavelength of light that activates the dye molecule on the ASP-1929 are illuminated.
Twenty-four hours after the administration of the study drug, catheters are inserted into the tumor and lasers emitting a wavelength of light that activates the dye molecule on the ASP-1929 are illuminated.

by Tom Wilemon

Vanderbilt-Ingram Cancer Center (VICC) is recruiting patients for a clinical trial using photoimmunotherapy for recurrent head and neck cancer.

This newly developed treatment chemically links a light-activated dye to the monoclonal antibody cetuximab, which selectively targets epidermal growth factor receptors on cancer cells.

This conjugated monoclonal antibody, called ASP-1929, is administered by infusion. The next day, catheters inserted directly into the tumor deliver red light generated by a laser device.

In this approach, ASP-1929 delivers the dye selectively to the tumor, where it is then activated only in the area illuminated by the laser. The treatment is designed to kill cancer cells directly, such that normal tissues are spared, while concurrently activating an immunological response.

ASP-1929 was developed by Rakuten Medical Inc. based in San Mateo, California.

“Cetuximab is a drug that is already used for head and neck cancer. What Rakuten did is leverage cetuximab as a carrier that is linked to this novel molecule that is activated by the laser light only in the tumor.

By using an already approved antibody that targets the tumor selectively, Rakuten ensures specific delivery to and activation only of the drug in the tumor,” said Michael Gibson, MD, associate professor of Medicine and director of Translational Therapeutics for Head and Neck Oncology.

The clinical trial (NCT03769506) is a single arm investigation, meaning that all patients will be given ASP-1929 and undergo the photoimmunotherapy procedure.

ASP-1929 is a first-in-class therapy and has received Fast Track designation from the U.S. Food and Drug Administration, which expedites the review process for potential therapies intended for unmet medical needs and serious or life-threatening conditions.

“Most cancers of the head and neck recur locally, meaning where they initially started. Given that this location serves critical functions such as speaking, breathing and eating, it is particularly important to have a directed therapy to this location, especially when surgery and radiation are no longer options. In addition to current standard-of-care therapies (chemotherapy, targeted therapy, immunotherapy), the ASP-1929 hopefully will provide a beneficial approach, while preserving critical functions, that is associated with fewer local and systemic (whole body) side effects,” Gibson said.

Immunotherapies and chemotherapies are administered as palliative treatments to extend life and maintain quality of life.

“Vanderbilt’s role and function are to provide a center for novel, innovative treatments, which is why we are a referral center for a large, multi-state area. We have the highest volume of head and neck cancers of any other institution in the United States. Not only do we have a huge volume of head and neck cancer patients and an excellent research program, but this is something Vanderbilt is really made to do because it involves bringing in a novel drug to medical oncology. You’ve also got to have a surgeon who uses catheters to transmit light in the operating room. You have to have a whole technology group to license the equipment, make sure it works and do other checks. Doing something like this takes a fair amount of effort, but it’s a pleasure to do,” Gibson said.

Kyle Mannion, MD, associate professor of Otolaryngology-Head and Neck Surgery, is the principal investigator at VICC. For more information about this clinical trial and others at VICC, call 800-811-8480.

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