One of Kite Pharma’s CAR-T patients died from cerebral edema, triggering a safety alarm
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Kite Pharma exposed today that one of the patients in their late-stage program for the CAR-T drug KTE-C19 died from cerebral edema, the same brain erection condition that went on to scuttle Juno Therapeutics’ lead drug.
In a call with analysts for their Q1 report, the closely-watched biotech $KITE said that they had informed the FDA and there was no pause or halt to the investigate. The death in late April, tho’, clearly raised a crimson flag for analysts after Kite had managed to get all the way through a pivotal program without a death due to cerebral edema after treating hundreds of patients.
David Chang, Kite
“It took about two days of progressively worsening neurological events,” commented Kite CMO David Chang. “In this time the patient’s overall condition was deteriorating.”
“This patient had refractory non-Hodgkin lymphoma,” added Chang. “At the time of enrollment he had explosive disease that was rapidly progressing and had a lot of symptoms from the tumor.” There was fever, concerns about underlying infections – tho’ tests came back negative — and “pretty rapidly progressing disease.”
In an email, a spokesperson for Kite noted that “we don’t see any safety concerns. All axi-cel and KTE-C19 development studies proceed as planned. As a reminder, overall incidence of KTE-C19 related grade five events stands at 2% in approximate two hundred patients treated in our probe supports the benefit of axi-cel and KTE-C19. If patients treated in the NCI studies are included, over three hundred patients have been treated with KTE-C19.”
Kite’s shares dropped 10% as news of the death spread.
Kite had wished to concentrate today primarily on its commercialization plans for this drug, looking to a possible FDA approval later in the year. But after Juno was compelled to shelve JCAR015 after it killed five patients who suffered cerebral edema, the news clearly captured analysts’ attention.
The FDA quickly lifted their very first clinical hold on Juno’s drug after the very first three deaths, indicating regulators’ allowance for the advanced state most of these cancer patients are in when they get into a CAR-T investigate. When two more patients died soon after the hold was lifted, tho’, that practice could raise questions of whether regulators may have become more sensitive to the safety issues involved with these drugs.
Juno had originally blamed the very first group of deaths on the use of fludarabine during the preconditioning regimen patients go through to make them more receptive to cell therapy. So they dropped it, then spotted more patients die. The flu/cy combo, however, was used by Kite and others. Kite believes it has just the right mix to build up efficacy without creating unreasonable safety issues.
These drugs — reengineered T cells taken from patients and then reinfused — have had safety issues from the very beginning, with a number of patients suffering from cytokine storms that at times turned lethal.
Chang said that they would proceed to consider the efficacy and safety of the drug as more studies proceed.
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