Biopharmaceutical company Juno Therapeutics, has announced that more patients participating in their CAR-T immunotherapy clinical trial, have died as a result of the treatment. Two patients suffered severe cerebral edema – swelling of the brain – which led to the death of one patient, and the prediction that the other will not recover.
The Phase II clinical trial of Juno’s JCAR015 – named ROCKET – was voluntarily placed on hold following the adverse events. Just a few months ago, three patients with relapsed or refractory B cell acute lymphoblastic leukemia died during the course of the study, prompting the US Food and Drug Administration (FDA) to enforce a temporary clinical hold while the deaths were investigated.
Juno quickly identified a specific chemotherapy drug, fludarabine, as the cause of the patient deaths, which was used as a pre-conditioning treatment before the CAR-T cell therapy was administered. However, even after removing this drug from the study protocol after resuming the trial, the ROCKET trial has still been plagued by more patient deaths.
It is our view that the removal of fludarabine has reduced the incidence of severe neurotoxicity,” said Hans Bishop, CEO of Juno Therapeutics in a conference call regarding the trial last week. “It just hasn’t gotten us as far as we hoped that it would.”
Now that five patient deaths have been associated with the CAR-T immunotherapy trial, Juno is sure to face many questions regarding the safety of JCAR015. As the FDA was the one to allow the clinical trial to continue following the first deaths, the regulatory agency will likely face increased scrutiny over the coming weeks.
“It’s just terrible,” Brad Loncar, founder of a cancer immunotherapy fund, told Stat News. “They’ve killed a couple of people, and it seems like, in part, it’s because of the rush to judgment.”
According to Bishop, the patients participating in the ROCKET trial were already suffering the effects of the rare, but highly-lethal form of blood cancer before joining the study. As Juno still has other CAR-T clinical trials on the go, they could still meet their target of launching their first therapeutic by 2018.