© ISTOCK.COM/CREATIVE_OUTLETIn 2015, biopharmaceutical company Juno Therapeutics launched a Phase 2 trial testing a therapy for adult relapsed and refractory acute lymphoblastic leukemia (ALL), a blood cancer that, with current treatments, only 10 percent of patients survive past five years. Developed in collaboration with researchers at Memorial Sloan Kettering Cancer Center, Juno’s chimeric antigen receptor (CAR) T-cell therapy JCAR015 was engineered with a specific protein to help the immune cells recognize, and selectively kill, tumor cells displaying the CD19 antigen on their surface. Like other CAR T-cell products in development, the therapy had shown tantalizing potential, achieving remission in patients for whom other treatments had failed.
But in May 2016, things started to go terribly wrong; one of the 68 patients being treated with JCAR015 died from cerebral edema, a swelling of the brain. Then in July, another two patients died from the same condition and the trial was suspended. After appealing to the US Food and Drug Administration (FDA), Juno investigators recommenced the trial, omitting an accompanying chemotherapy drug they suspected was responsible for the adverse reactions—only to have the study halted again after two more deaths from cerebral edema in November.
The fatalities, widely reported and discussed, came as a blow to the field, with some investors and health care analysts questioning whether the company—and the FDA—had acted responsibly. By early 2017, Juno’s shares had sunk to less than ...
