In a development with an uncomfortable parallel, Kite Pharma reported a death in a clinical trial of a cancer immunotherapy based on chimeric antigen receptor T-cell technology, commonly known as CAR-T therapy.
CAR-T therapies are created by removing T cells from a patient, engineering them to hunt a specific kind of cancer cell, growing them in a bioreactor, and then returning them to the patient.
In clinical trials, CAR-T therapies can almost magically melt tumors away. But putting live, supercharged cells into the body is a new frontier. In the case of the Kite drug, a lymphoma treatment called KTE-C19, the patient’s new T cells released an outsize immune response. The result was cerebral edema—swelling of the brain—and death.
The development is troubling because five patients in a clinical trial conducted by another CAR-T therapy developer, Juno Therapeutics, died from similar causes. Juno discontinued the trial after the last two deaths, in March.
In a conference call with investors last week, Kite executives said they will continue the KTE-C19 trial. David D. Chang, Kite’s chief medical officer, noted that the patient was very sick before treatment and was not responding to other lymphoma therapies. The death was the first, he said, among the more than 300 patients who have been treated with KTE-C19.
Jacob Plieth, an analyst with the pharmaceutical research firm Evaluate, wrote that the death is perhaps not surprising because KTE-C19 and the Juno drug are similar, differing only in the binding region they use. Researchers don’t know why certain patients are susceptible to a deadly immune response.
Kite, Juno, and Novartis all want to win the first approval for a CAR-T therapy. Novartis’s lead product, Plieth noted, is constructed differently from the other two. Investors and other industry watchers, he said, are keen to see clinical trial data that Novartis plans to release next month.