By: Matthew Harper
The genetically altered, cancer-killing T-cells known as CARTs showed dramatic results in non-Hodgkin lymphoma as the two leading players, the Swiss drug giant Novartis and the Seattle upstart Juno Therapeutics, pushed forward with new clinical trials.
The new results are to be presented at the annual meeting of the American Society of Clinical Oncology by academics working with both companies.
“I’ve had patients wheeled into the office in wheelchairs that are now leading normal lives,” says Stephen Schuster, MD, the Robert and Margarita Louis-Dreyfus Associate Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research at the University of Pennsylvania, who is working with Novartis. “It’s spectacular therapy.”
The Penn group is presenting data from 19 patients with NHL that had failed treatment with chemotherapy and the cancer drug Rituxan. These patients have no treatment options and often fail bone marrow transplants.
In one type of NHL, called diffuse B cell lymphoma, 6 of 12 patients saw their disease reduced (called a response), including five who had a complete response, meaning that the cancer became undetectable. In a second type, called follicular lymphoma, all seven patients had a response, and in six patients it was a complete response. Schuster says the complete responses are “durable.” He adds: “I could actually see this replacing transplant in lymphomas.”
Schuster says that Novartis is planning a large, multicenter trial to test the cells in diffuse B-cell lymphoma. Novartis’ existing trial, in acute lymphoblastic lymphoma (ALL) , is running in the U.S. but no patients have yet been dosed in Europe, according to a company spokeswoman. She says the company has a “stretch goal” of filing with the Food and Drug Administration for approval in ALL next year and in diffuse B-cell lymphoma in 2017.
Juno is presenting similarly impressive data. In a dose-ranging study using CART cells developed at the Fred Hutchison Cancer Institute in NHL, 12 of 19 patients (63%) had a response.
But the data became even better when researchers used chemotherapy drugs to deplete white blood cells before they gave the treatment. Then, the Juno CART resulted in complete or partial responses in 6 of 7 patients, an 86% response rate.
However, two patients who got a very high dose of the Juno CART died. Juno says that no deaths occurred at doses that will be used in future trials, and that it has no plans to move this particular genetically engineered cell into studies that would lead to FDA approval.
Juno is also starting a multicenter trial of its cells, although that will be based in the U.S. Another CART company, Kite Pharmaceuticals, is in the process of starting a trial, too.
“The CART cell data I think is really exciting,” says Julie Vose, a hematologist/oncologist at the University Nebraska Medical Center and the president of ASCO. “We have to figure out which patients are responding to it. It is potentially a toxic therapy, and we want to utilize it only in those patients that really need it.”
She says that it is in the multicenter trials that we’ll really get a sense of the potential of these cells. Her medical center is participating in trials with Kite and Juno.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.