New FDA-approved cancer therapy ‘eats’ tumors

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Steve Fulkert of southern Delaware County was running out of options. He had been living with a slow-growing form of lymphoma for nearly six years. Chemotherapy had been keeping the cancer at bay, but in 2015 he was diagnosed with diffuse large B-cell lymphoma (DLBCL), a rare and aggressive form of the disease.

In 2016 his oncologist referred Fulkert, 63, to The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), which was conducting clinical trials on a new cancer immunotherapy.

Called CAR T-cell, the therapy was recently approved by the U.S. Food and Drug Administration (FDA) and is showing promise for cancer patients with advanced lymphoma where standard treatments have failed.

The therapy involves extracting a patient’s white cells, which are then modified in a lab, retrained to identify specific markers on cancer cells and then infused back into the patient. These retrained white cells seek out and kill the cancer, says Samantha Jaglowski, MD, who leads the CAR T-cell research trials at the OSUCCC – James.

“It’s incredible to watch; you can literally feel the tumor shrinking,” Jaglowski says. “It’s almost like they are eating the cancer.”

While chemotherapy, radiation or stem cell treatment are still the first-line, or standard, treatments for DLBCL, CAR T-cell therapy offers patients an alternative treatment when those have failed — one that is less disruptive to their daily lives and has minimal side effects.

Currently, about 7,400 patients in the United States would be eligible for CAR T-cell therapy, Jaglowski says. Each year about 7 of every 100,000 people are diagnosed with DLBCL, the most common form of non-Hodgkin lymphoma. But when those treatments haven’t worked, CAR T-cell therapy has provided patients with another option.

In recent clinical trials, about 60 percent of patients who failed at least two rounds of chemotherapy or stem cell treatment responded to CAR T-cell treatment. Of those, “about 40 percent have stayed in remission after three months,” she says.

Fulkert continues to do well. Each day he got a little better, he says, and eventually, the pain subsided. Testing performed 90 days after Fulkert’s CAR T-cell treatment showed no signs of disease.

CAR T-cell therapy takes about a month from beginning to end and is a “highly individualized” process for each patient, Jaglowski says. After the cells have been extracted from a patient they are sent to a lab to be retrained. After the incubation period, they are frozen and returned to the hospital that is delivering the treatment.

Patients undergo three days of chemotherapy prior to the therapy to “shrink the tumors and make space for the new cells,” Jaglowski says. Patients stay in the hospital about a week to undergo monitoring for side effects.

Side effects typically appear within a couple of days.

Patients can experience cytokine release syndrome in which the T-cells infused back into the body expand quickly. Symptoms can include fever, vomiting, headaches and other sometimes life-threatening consequences such as cardiac arrest.

“Most of the time (the side effects) are not bad and are reversible,” which is why patients are monitored for at least a week after the treatment, she says.

While patients have shown promising results, it is still not yet well defined whether additional treatments would be needed or beneficial, Jaglowski says. Phase III clinical trials will involve introducing the treatment earlier to patients.

CAR T-cell also has been FDA approved for a rare type of treatment-resistant childhood leukemia. In addition, the OSUCCC – James is conducting CAR T-cell therapy clinical trials for use in treating sarcoma, cervical and lung cancer.

To learn more about CAR T-cell therapy, visit cancer.osu.edu/cart