Three Deaths In Trial Mean Clinical Hold For Juno’s Lead CAR-T Therapy
Juno Therapeutics Inc. planned to win US FDA approval in 2017 for its chimeric antigen receptor T cell (CAR-T) cell therapy JCAR015, but the company has reached another significant milestone that may delay that goal: its Phase II ROCKET clinical trial in the treatment of adults with relapsed or refractory B cell acute lymphoblastic lymphoma (ALL) has been put on clinical hold due to three deaths.
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Juno and partner Celgene closed the ROCKET study for JCAR015, which has been on clinical hold since November, and ended development in ALL in favor of its new and improved CD19-targeting CAR-T therapies.
Novartis and Kite both are set to submit their CD19-targeting CAR-T therapies for US FDA approval in early 2017, while neurotoxic deaths for two of Juno’s product candidates cast doubts on its programs.
Juno stressed structural differences, safety record and potential of its JCAR017 CAR-T therapy during a Nov. 23 call about the disappointing hold on its ROCKET ALL study for JCAR015 – the second clinical hold for the company’s most advanced development program.