Adult Leukemia Trial Put on Hold After Additional Deaths

Juno Therapeutics is working on an immunotherapy for adults with refractory B cell acute lymphoblastic leukemia.

Its phase 2 trial was recently placed on hold for the second time this year following the death of two patients who developed cerebral edema, just days after receiving their treatment.8 One of the patients was under the age of 30.

In July, the FDA ordered a clinical hold on the trial following the death of three patients. They too died from cerebral edema. As reported by CNN:9

“… [I]nvestigators pinpointed the likely culprit as the addition of fludarabine to the pre-conditioning regimen. Fludarabine is a chemotherapy drug used here as a one-time primer for treatment … in an effort to increase the effectiveness of the experimental therapy.

In this particular course of treatment, pre-conditioning consists of a heavy dose of chemotherapy to kill off existing cancer cells in order to give the new cancer-killing T-cells room to grow.

It’s like hitting a reset button to restart the immune system. But an unforeseen interaction between fludarabine and genetically modified JCAR015 cells proved to be lethal.”

The trial was given the green light to resume in August — this time without the use of fludarabine. Still, two patients are dead from the same exact problem as the initial three, suggesting the chemotherapy drug wasn’t the problem after all.

Brad Loncar, founder of a cancer immunotherapy fund told STAT News10 that Juno was “going way too fast. It’s just terrible. They’ve killed a couple of people, and it seems like, in part, it’s because of the rush to judgment.”

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