The most important question is durability of remission in large cell lymphoma. This compared favorably to any other conventional therapy that one would give these patients. These are high-risk patients-70% of them have chemorefractory disease, 20% have double-hit lymphoma, about half of patients have never achieved a CR to prior therapies, and 40% have had a prior stem cell transplant, most of which were autologous. The median prior line is 3, and some patients received up to 8. All patients have had at least 2 prior lines of therapy. All patients have now reached the 6-month time point or beyond, so we are really dealing with maturing data at this point. We have 102 patients who have been treated with liso-cel. Based on the results of that, we have expanded into a pivotal cohort of the trial.At the 2018 ASCO Annual Meeting, I updated the results from the dose-finding and dose-escalation cohorts-the first 2 phases of the study. What are the updated findings with this study?īased on the findings in that component of the study, we expanded into 2 dose-expansion cohorts, which was both dose level 1 and dose level 2, each administered in a single dose. a single-dose level of 50 million cells administered at a single dose, a double-dose level of the same dose of 50 million cells administered 2 weeks apart, and then a dose level of 100 million cells as a single dose. We began with a dose-finding component of the study, where we looked at 3 dose levels. What that results in is a fixed precise dose of CD4 and CD8 CAR-positive T cells administered to every patient. We separated the CD4 and CD8 cells, then they were separately transduced and expanded, and then administered back to patients in a 1:1 ratio. Liso-cel targets CD19 using a 4-1BB costimulatory domain, and signals CD3 zeta. Abramson: The TRANSCEND trial is a pivotal trial looking at the anti-CD19 CAR T-cell product JCAR017, now known as lisocabtagene maraleucel, in relapsed/refractory aggressive B-cell lymphomas. Abramson, MD, MMSc, clinical director, Center for Lymphoma, Massachusetts General Hospital, discussed the latest data for liso-cel and its potential to become the third FDA-approved CD19-targeted CAR T-cell therapy. In an interview with OncLive during ASCO, lead investigator Jeremy S. OncLive: What is the background of the TRANSCEND trial? Among patients who achieved a partial response, the median OS was 10.3 months (95% CI, 6.8-not evaluable) and the 1-year OS rate was 33% (95% CI, 9%-60%). The 12-month OS rate in these patients was 89% (95% CI, 72%-96%). The median overall survival (OS) had not been reached among patients who achieved a CR at the pivotal dose. This phase I, multicenter trial also showed durable responses across poor-risk DLBCL subgroups, including those who are chemorefractory. Updated findings from the TRANSCEND trial presented at the 2018 ASCO Annual Meeting showed a complete response (CR) rate of 46% (95% CI, 30%-63%) at 6 months, as well as an ongoing objective response rate of 49% (95% CI, 32%-66%). The CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (JCAR017 liso-cel) is showing promising response rates in patients with high-risk diffuse large B-cell lymphoma (DLBCL).
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