Three patients enrolled in Juno Therapeutics' cancer trial have died, leading the US Food and Drug Administration to halt the study, Forbes reports. The patients died of cerebral edema.
"This is a humbling experience," Juno CEO Hans Bishop tells Forbes. "No doubt it is difficult for the physicians who are looking after these patients and their families. Clearly these therapies are potent, that's why they offer the potential for cures. We're still learning to use them in the safest, most efficacious way."
The ROCKET trial was testing a chimeric antigen receptor T-cell (CART) treatment in which immune cells are extracted from patients' blood, engineered to attack cancer cells, and returned to the patients. Forbes' Matthew Herper notes that this type of therapeutic approach has turned heads, as "it seems to make cancer disappear, at least temporarily, in patients who have failed other treatments." Other companies are developing similar therapies.
Juno executives say the deaths in the trial are likely due to the combination of the CART treatment and chemotherapy given to the patients, the New York Times adds. It adds that the deaths all occurred among patients who'd received a dual chemotherapy treatment of cyclophosphamide and fludarabine.
There were no deaths reported among the dozen or so patients who'd received only cyclophosphamide, the Times says. The company had recently added fludarabine to make the treatment more effective.
Juno has proposed to FDA to continue the trial without fludarabine.