Juno Therapeutics reports data from 'TRANSCEND' trial of JCAR017
Juno Therapeutics presented data from the TRANSCEND trial of JCAR017 in relapsed and refractory aggressive B cell non-Hodgkin lymphoma at the International Conference on Malignant Lymphoma. "High rates of durable responses and the early survival data are especially exciting, as is the emerging safety profile. The majority of TRANSCEND patients experienced no cytokine release syndrome or neurotoxicity at all. While still early, these data suggest that JCAR017 could be administered on an outpatient basis," the company remarked. Data for the DLBCL cohort were presented in two groups, core and full. The core analysis group includes patients that represent the population that Juno plans to move forward into a pivotal trial in the second half of 2017. For the core group, findings include: Overall response rate is 86% and the complete response is 59%. Three-month ORR is 66% and CR is 50%. Of patients in response at three months, 90% continue in response at six months. Early data suggest a dose response relationship at three months. 97% of responding patients are alive and in follow-up as of May 4. 2% experienced severe CRS and 18% experienced severe NT. 66% did not experience any CRS or NT. No deaths were reported from CRS or NT. There was one Grade 5 adverse event of diffuse alveolar damage, which the investigator assessed as possibly related to fludarabine, cyclophosphamide, and JCAR017 treatment, occurring on day 23 in an 82-year-old subject who refused mechanical ventilation for progressive respiratory failure while neutropenic on growth factors and broad spectrum antibiotics and antifungals. This patient had no CRS and Grade 3 neurotoxicity resolution before the Grade 5 event. Regarding manufacturing Juno stated: "Product was available for 98% of patients apheresed... Juno expects commercial production will be accomplished in less than 21 days, and Juno is investing in manufacturing infrastructure to enable a smooth prescribing experience with a reliable delivery time at market entry."