For those achieving a CR, the median overall survival (OS) had not yet been reached. The 6-month OS rate in those achieving a CR was 92% in the full group and 94% in the core group. The 6-month OS rate in those with a partial remission (PR) was 75% and 81%, in the full and core groups, respectively. The median OS in those with a PR was 9 months.
"Overall survival compares favorably to historical controls for chemorefractory DLBCL," said Abramson. "In patients in the core group, at 1 year, overall survival was 73%."
Across the full study, 1 patient experienced severe CRS and 11 had severe neurotoxicity (12%). CRS of any grade was experienced by 35% of patients and 19% had neurotoxicity of any grade. Fifty-five patients (60%) did not experience CRS or neurotoxicity of any grade. The median time to onset of CRS was 5 days (range, 1-14) and for neurotoxicity it was 10 days (range, 3-23). Twelve percent of patients received tocilizumab and 16% received dexamethasone.
The 1 case of severe CRS was seen in the core study population at the DL1 dose. In this group, severe neurotoxicity was experienced by 15% of patients. In the DL2 group, the severe CRS and neurotoxicity rates were 0% and 7%. All-grade CRS and neurotoxicity was experienced by 36% and 21% of patients, respectively, in the core population. Overall, 58% of patients did not experience CRS or neurotoxicity.
Outside of CRS and neurotoxicity, the most common treatment-emergent adverse events (TEAEs) were neutropenia (49%), anemia (38%), fatigue (37%), thrombocytopenia (29%), nausea (27%), and diarrhea (25%).
"There were low rates of severe CRS and neurotoxicity, with only a single case of severe CRS," said Abramson. "Evaluation of outpatient administration is ongoing in the pivotal cohort."
The pivotal cohort of the TRANSCEND trial exploring DL2 of liso-cel is currently enrolling patients with DLBCL (NCT02631044). If positive, Juno Therapeutics, the company developing liso-cell plans to submit a biologics license application to the FDA. Based on earlier findings for the CAR T-cell therapy, liso-cel received a breakthrough therapy designation from the FDA for non-Hodgkin lymphoma in December 2016.
Abramson JS, Palomba ML, Gordon LI, et al. High Durable CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with the CD19-Directed CAR T Cell Product JCAR017 (TRANSCEND NHL 001): Defined Composition Allows for Dose-Finding and Definition of Pivotal Cohort. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta, Georgia. Abstract 581.