The University of Kansas Cancer Center will be one of 16 sites nationwide approved to offer a new immunotherapy that made national headlines this week as the second commercially available treatment that uses genetic engineering to target and kill cancer cells.
The therapy, called Yescarta, treats patients with non-Hodgkin’s lymphoma. Joseph McGuirk, a doctor at KU who participated in clinical trials for the therapy, said it’s part of a series of research studies that could forever change the way cancer is treated.
“In 30 years, this is the most exciting time of my entire career because we’re in the midst of a revolution,” McGuirk said. “What our public is witnessing is a revolution in cancer medicine and this is the most recent example of that.”
The chimeric antigen receptor, or CAR-T, treatments extract a cancer patient’s own immune system cells, genetically engineer them into cancer-fighting machines and then inject them back into the body.
The U.S. Food and Drug Administration approved the first one, Kymriah, in August for treating leukemia. The FDA approved Yescarta this week. McGuirk said more CAR-T treatments are in development, including some for solid tumor cancers.
“It’s not hyperbole to say these are really revolutionary changes in cancer management,” McGuirk said. “They truly are, and it’s just the tip of the iceberg.”
Kymriah, sold by Novartis, is approved only for patients 25 and under with acute lymphoblastic leukemia. Children’s Mercy Hospital is one of the clinical trial sites for the therapy but is not yet among the sites approved to sell it commercially, which would open it to a much larger group of patients.
KU expects to be offering Yescarta commercially within 30 days.
It could some day displace standard treatment chemotherapy as the first-line treatment for non-Hodgkin’s lymphoma. But for now, with limited data on success rates and a danger of severe side effects, it’s a last resort.
McGuirk said it will only be available for patients who have not seen results from chemotherapy, or have relapsed after chemotherapy and a stem cell transplant. Without Yescarta, those patients are in dire straits.
“The overwhelming majority of those patients will die from their disease,” McGuirk said. “Average survival is about six months in that setting and single-digit survival rates at two years.”
But in a multicenter trial of Yescarta with more than 100 patients, the FDA said 51 percent of them experienced a complete remission, though it’s not yet known how durable those remissions will be.
Yescarta’s manufacturer, Kite Pharma, estimates that about 7,500 people in the United States will be eligible for the therapy each year.
Kite’s parent company, Gilead Sciences, is only allowed to offer Yescarta at a limited number of locations because, like other CAR-T treatments, it carries with it significant risk of severe side effects. McGuirk said patients have to be monitored closely and have access to a multi-disciplinary team of medical experts and a skilled intensive care unit in case something goes wrong.
“Death is very unusual, however toxicities are common,” McGuirk said. “But they are again manageable for the overwhelming majority of patients.”
Gilead released the full list Friday of the 16 sites authorized to dispense Yescarta. Siteman Cancer Center, a hospital in St. Louis that is affiliated with Washington University also made the list.
Siteman is also authorized to dispense Kymriah, through Siteman Kids at St. Louis Children’s Hospital.
“Those patients they are really, really difficult to treat when they have that kind of cancer we’re dealing with — a deadly, unstoppable, irreversible type of cancer,” said said Siteman doctor Armin Ghobadi. “That’s why I’m really excited about the CAR-T treatments.”
They come at a hefty price, though. Kymriah retails for about $475,000, Yescarta is slated to cost $373,000 and it’s still unknown whether insurance companies will agree to cover it.
“It is an extremely costly therapy, unquestionably,” McGuirk said. “That’s an important issue, of course.”
But McGuirk said that should be weighed against the value of cancers sent into remission and lives saved.
List of sites
▪ Stanford Health Care; Stanford, Calif.
▪ City of Hope; Duarte, Calif.
▪ Sylvester Comprehensive Cancer Center; Miami
▪ Moffitt Cancer Center; Tampa, Fla.
▪ University of Chicago Medicine; Chicago
▪ The University of Kansas Cancer Center; Kansas City, Kan.
▪ Dana-Farber/Brigham and Women’s Cancer Center; Boston
▪ Massachusetts General Hospital Cancer Center; Boston
▪ Barbara Ann Karmanos Cancer Institute; Detroit
▪ Mayo Clinic; Rochester, Minn.
▪ Siteman Cancer Center; St. Louis
▪ Memorial Sloan Kettering Cancer Center; New York City
▪ The Ohio State University Comprehensive Cancer Center; Columbus, Ohio
▪ Vanderbilt University Medical Center; Nashville, Tenn.
▪ The University of Texas MD Anderson Cancer Center; Houston
▪ Seattle Cancer Care Alliance; Seattle