Waitlists for clinical trials are already lengthy.
Jimmy Boyd, a 67-year-old warehouse manager from Louisiana, was diagnosed with lymphoma in March 2016. After radiation and multiple rounds of chemotherapy failed, his doctors signed him up for CAR-T in three hospitals across the U.S. It took six months for the first slot to open up, a Kite trial at MD Anderson Cancer Center in Houston.
It’s easy to understand why doctors are eager to try CAR-T with Boyd’s deadly type of malignancy as fast as they can. The median survival for patients at his stage of diffuse large B-cell lymphoma is only four months after all other treatments fail. yet in early CAR-T studies from Novartis and Kite, more than half of such patients saw their tumors shrink, and in about a third of the cases, cancer disappeared after three to six months.
CAR-T treatments are living drugs, engineered by genetically altering infection-fighting T-cells to destroy cancer. The process entails drawing a patient’s blood; extracting the T-cells; inserting a gene that will enable them to identify tumors as targets; then infusing the cancer-killing compound back into the patient at a specialized medical center.
Boyd will soon return to Houston to get his infusion. If it works, he could be back to his hobby, fishing sea bass, in a month. “I feel real optimistic,” he said. “I really do.”
Infusion Centers
The complexity of production was underscored in the early results from a Novartis trial last month. Of the 141 patients enrolled, 85 received the CAR-T cocktail. Novartis was unable to produce cells for nine patients, and 16 died before they could be infused.
The company said it has since updated its Morris Plains, New Jersey, processing plant and had a success rate of 97 percent for the last 30 patients enrolled. The Basel-based drugmaker expects a turnaround of about 22 days at approval time.
Time isn’t the only hurdle. Another roadblock is the lack of qualified infusion centers. Medical teams need to learn how to identify potentially deadly side effects including cytokine release syndrome, an inflammatory response to treatment that has killed several patients, swelling in the brain, and infections. Even experienced hospitals like Fox Chase Cancer Center in Northeast Philadelphia took months to get ready.
“In a general oncology unit, it’s probably very difficult, impossible or unsafe to do these types of cell therapy,” said Henry Fung, vice chairman of hematological malignancies at the 113-year-old center, one of the nation’s first cancer hospitals. “We need to have the whole team ready before we will start it."