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This was a dose-finding study of JCAR017, following preconditioning agents fludarabine/cyclophosphamide lymphodepletion. In total, two analysis groups were presented for the DLBCL cohort: core and full. The "core" analysis, of 44 patients, includes those that represent the population that will move forward into the biotech’s upcoming pivotal trial, which will begin in the second half of the year. This includes patients with DLBCL (de novo and transformed from follicular lymphoma). The "full" analysis represents all r/r patients in the DLBCL cohort, 55 patients in all, including the 11 patients with poor performance status or niche subtypes of aggressive NHL. When combining data across dose levels, the full data set shows the best ORR was 76% (41/54 patients) and CR 52%. And when using the core group, again combining data across dose levels, ORR hit 86% (38/44 patients) and the CR was 59%. Juno adds that 97% (37/38) of responding patients are alive and in follow up as of May 4, its cut-off date. But there was one death, an elderly patient in their 80s, in what Juno described as a “Grade 5 adverse event of diffuse alveolar damage, which the investigator assessed as related to fludarabine, cyclophosphamide, and JCAR017 treatment, occurring on day 23.” The 82-year-old patients was said to have refused mechanical ventilation for progressive respiratory failure, while neutropenic on growth factors and broad-spectrum antibiotics and antifungals.
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