Juno Therapeutics, the manufacturer of the experimental chimeric antigen receptor (CAR) therapy JCAR015 for patients with relapsed acute lymphocytic leukemia, announced that it will discontinue the development of JCAR015.
Last year, the FDA placed a clinical hold on phase II trials of JCAR015 following patient deaths from cerebral edema, but then allowed trials to resume. The manufacturers originally reported that the deaths were related to the addition of fludarabine to the pre-conditioning regimen, and they proposed that the trial continue with cyclophosphamide as a substitution.
However, after five patient deaths were reported, the manufacturer said its internal investigation identified multiple factors that increased the risk of severe toxic reactions, including “factors related to the product.”
The promising new class of immunotherapy, which removes T cells from a patient’s blood and re-engineers them to more efficiently attack cancer before returning them to the patient, was highly anticipated by health-care professionals and patients alike.
Source: Reuters, March 1, 2017.