Patient deaths lead Juno Therapeutics to halt trial for second time
pharmafile | November 24, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | acute lymphoblastic leukaemia, clinical trial deaths, juno therapeutics
Juno Therapeutics has been forced to halt a trial investigating the efficacy of its lead experimental CAR-T cancer treatment JCAR015 for acute lymphoblastic leukaemia (ALL) after two participants died following severe swelling of the brain. This disaster follows the deaths of three patients from cerebral edema in July earlier this year.
With a total of five losses of life, two after the trial was trial was restarted, serious questions are now being raised over the judgement passed by the FDA which enabled an obviously flawed and unsafe trial to resume after only a week. Juno has asserted that its treatment is not to blame, rather the combination of chemotherapy drugs administered to patients in the early stages of the trial. After removing fludarabine from this combination of drugs, the FDA gave the go-ahead to resume to trial.
“It is our view that the removal of fludarabine has reduced the incidence of severe neurotoxicity,” Juno CEO Hans Bishop said on a call Wednesday morning detailing the halt of the clinical trial. “It undoubtedly contributed in the way we expected, it just hasn’t gotten us as far as we hoped it would.”
The company also claimed that those enrolled for the trial were already in poor health before they began treatment: “These patients have virtually no other options, and have a highly lethal disease,” explained Bishop.
CAR-T therapies work by re-engineering the body’s immune cells to identify and destroy tumours. However, the field is only just being explored by experts; Juno’s executive vice president of portfolio strategy Dr Mark Frohlich, understanding the correlation between the use of CAR-T cells and the development of cerebral edema is now the company’s “big focus”.
Juno’s stock fell as much as 44% to their lowest-ever intraday level on the news, while the tragic events even had an effect on other users of CAR-T and similar approaches; Kite Pharma and Bluebird Bio stocks fell by 2.9% and 1.2% respectively after the news broke.
Matt Fellows
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