Anxious to turn the page on a deadly series of cerebral edema cases, Juno Therapeutics today turned to an upbeat set of preliminary data for JCAR017, which may soon emerge as its top drug in the pipeline.
Twelve of 20 patients who could be evaluated for efficacy in the study of CD19-positive cases of non-Hodgkin lymphoma demonstrated a complete response to the CAR-T therapy following treatment at dose level 1 (5×107 cells). There was some evidence of durability, with 42% of the patients (8/19) with diffuse large B-cell lymphoma treated more than three months before the data cutoff experiencing an ongoing response. And there were no cases of severe cytokine release syndrome with grade 3-4 neurotoxicity seen in three individuals among 22 in the dose level 1 group who were evaluable for safety.
Juno has repeatedly been hammered by setbacks on JCAR015, a lead CAR-T that has been linked to 5 patient deaths. The biotech was forced to resume a clinical hold recently after two new deaths from brain swelling stunned investors.
Juno had reassured the FDA that it could eliminate cases of cerebral edemas by eliminating fludarabine, a conditioning agent used along with cyclophosphamide in a combo designed to help patients respond favorably to the cell therapy, designed to attack cancer cells.
The turmoil at Juno has thrown the biotech well off a track that once promised to seek an approval in 2017. JCAR015’s approval was pushed back to 2018, and now a number of observers are waiting to see if Juno simply drops JCAR015 and turns its attention to JCAR017 as its best shot at a best-in-class contender.
Novartis and Kite, meanwhile, are both planning on Q1 applications for their leading efforts, putting them well ahead of Juno on the pacing.
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