Cooper offers a world-first test of newly approved melanoma therapy to be made in Philly

Debra Marsdale’s heart sank when doctors confirmed the golf ball-size lump she’d felt near her armpit was cancer. Specifically, melanoma that had spread from a tiny spot somewhere on her skin to large tumors in her body.

The disease can be deadly, but Marsdale may have much better odds.

Last summer, Marsdale became the first person in the world to receive a new therapy that aims to train the body’s immune system to fight advanced melanoma as her initial cancer treatment through a clinical trial involving MD Anderson Cancer Center at Cooper. The 64-year-old small business owner from Moorestown, N.J., continues to check in with doctors but is doing well, with no signs the disease has spread.

The therapy, Amtagvi by Iovance Biotherapeutics, will ultimately be manufactured out of Philadelphia’s Navy Yard. The Food and Drug Administration approved it last week for advanced melanoma patients who have already tried chemotherapy and other available skin cancer treatments.

Marsdale was part of a late-stage clinical trial to test whether the technique is safe and effective for its use to be expanded to people like her, who have not yet received other cancer therapies.

The treatment involves removing disease-fighting white blood cells, called T cells, and supercharging them in a lab. Once the cells have multiplied into the billions, they’re reinfused into the body to attack tumors.

The technique is “the ultimate personalized medicine,” said Young Ki Hong, an oncologist at Cooper who is leading the New Jersey institute’s trial participation.

The technique is an important step toward treating solid tumors with cell therapy, which so far has found most of its success against blood cancers. Chimeric antigen receptor T cell, or CAR-T, therapy was pioneered at University of Pennsylvania. Researchers are still learning how to apply the approach to solid tumors that account for the vast majority of cancers.

But Amtagvi’s sticker price of $515,000 could limit access for patients outside of clinical trials, which offer the therapy free of charge.

Melanoma, one of the most common types of skin cancer, is highly treatable with surgery when caught early.

But the disease is much harder to treat once it has spread to other parts of the body. Only one in three people diagnosed with such advanced melanoma are still alive after five years, according to average relative survival rates from the American Cancer Society.

Advanced melanoma that has spread to other parts of the body is typically treated with a combination of surgery and immunotherapy to reduce the size of tumors. Patients often receive ongoing treatments to reduce tumor growth, but in many cases the cancer cannot be entirely removed.

Amtagvi aims to eliminate advanced melanoma tumors through an aggressive one-time treatment.

The technique starts by removing a tumor, where T cells have already begun to flock in an attempt to attack it. The tumor is sent to a specialty lab and the T cells are extracted. Once separated from the tumor, the T cells are cultivated and grown into the billions to supercharge the potency against the patient’s cancer.

Patients are given seven days of chemotherapy to suppress the immune system and clear a path for the army of supercharged T cells. The T cells are infused back into the patient, where they attack the melanoma tumors.

The treatment takes a total of 14 days.

Every patient’s cancer is unique. And because the T cells were extracted from the patient’s melanoma tumor, they are uniquely programmed to recognize and target that specific tumor composition.

“They respond only to your cancer,” Hong said. “They can’t be given to anyone else on the planet.”

Last week, the FDA granted accelerated approval for Amtagvi’s use among patients who have already tried other immunotherapies.

California-based pharmaceutical company Iovance plans to manufacture Amtagvi in Philadelphia.

Iovance has a 136,000-square-foot manufacturing facility in Philadelphia’s Navy Yard neighborhood, where it will extract T cells from patients’ tumors and grow them into the billions.

After building out another lab in nearby shell space, Iovance will have capacity to manufacture Amtagvi for up to 5,000 patients a year.

The company has partnered with WuXi Advanced Therapies for additional manufacturing support.

The clinical trial Marsdale participated in is an important step toward potentially making the therapy available to advanced melanoma patients earlier in their treatment, which could keep many alive longer, said Hong.

Marsdale is grateful to have been part of the trial, though she initially questioned whether she was emotionally strong enough for an experimental treatment. Her husband died in 2021 after an eight-year cancer battle, and she’d recently downsized from the home where they raised their three children to a condo a few towns over.

She worried about putting her printing business — and main source of income — on hold while hospitalized for two weeks.

But eventually, she said, “I came to my senses.”

“If you have cutting edge technology that’s going to change the course of medicine, you are almost responsible to take advantage of it,” she said.