How The FDA’s Approval of a New Immunotherapy Improves The Treatment of Eye Cancer

Dr. Jeffrey Weber, NYU Langone Health oncologist and melanoma specialist tells SurvivorNet the approval is a "game-changer," since the options went from nothing to something that has been shown effective.

Approximately 2,500 people a year are diagnosed with ocular melanoma.

Ocular melanoma can be difficult to diagnose since it often develops on part of the eye that can’t be seen. While most people don't experience symptoms, those that do may find a dark spot on the iris (the colored part of the eye) or conjunctiva (the tissue covering the white of the eye) or experience blurred or distorted vision, a blind spot in side vision or the sensation of flashing lights. Ocular melanoma is often detected during a routine eye exam.

"Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients," Dr. John Kirkwood, director of the Melanoma Center at the UPMC Hillman Cancer Center, said in a statement. "The approval of (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer."

Who Can Use This New Medication?

Tebentafusp is approved for patients 18 and older who test positive for  HLA-A*02:01, a variant gene, which, according to the makers of Kimmtrak, approximately 50 percent of people carry.

The approval was based on a clinical trial of 378 patients in which some were given tebentafusp, and the control group was given either a checkpoint inhibitor immunotherapy or chemotherapy. (Checkpoint inhibitors work by releasing a natural brake on your immune system so that immune cells called T cells recognize and attack tumors.)

• Tebentafusp was shown to "significantly extend overall survival."
• Overall survival at 1 year was 73% in the tebentafusp group and 59% in the control group.

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Tebentafusp works by mobilizing and activating a person's own immune system T cells to fight the cancer. It is a part of a new class of immunotherapies called Bispecific T cell engagers or BiTEs. BiTEs physically link a T cell to a tumor cell, ultimately stimulating T cell activation, tumor killing and cytokine production. Tebentafusp is administered once a week via an IV infusion that takes 15-20 minutes.

What Are The Side Effects of Tebentafusp?

As with most drugs, there's the possibility of side effects. According to the FDA,  those most commonly experienced when taking tebentafusp include:

• Cytokine release syndrome
• Rash
• Fever
• Itching
• Fatigue
• Nausea
• Chills
• Abdominal pain
• Swelling
• Low blood pressure
• Dry skin
• Headache
• Vomiting

Cytokine release syndrome is a side effect of several different cancer treatments. When T cells begin to attack the cancer cells, they release signaling molecules called "cytokines." The release of cytokines can cause a number of symptoms and reactions that vary in terms of severity. Because symptoms can range from mild flu-like symptoms to life-threatening reactions, doctors will often refer to different "grades" of cytokine release syndrome.

The Future Of Melanoma Treatment

Dr. Weber says the approval of tebentafusp for ocular melanoma may lead to new treatments for other types of melanomas as well, such as cutaneous melanoma (melanoma of the skin), which is the most common type of melanoma worldwide.

"If it worked in ocular, why wouldn’t it work in cutaneous?" he says. "By the end of the year, we’ll hear more about whether tebentafusp works in skin melanoma. That’d be maybe a little bit of a game-changer too, because it’s probably not super toxic. So I like that idea."

Dr. Cecilia Larocca, a dermatologist at Dana Farber Cancer Institute, discuss how immunotherapy helps your body help itself

What To Ask Your Doctor

• Can tebentafusp help treat my cancer?
• Do I qualify for tebentafusp use?
• How does tebentafusp work?
• What are the side effects?
• How will we know if tebentafusp is working for me?

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