LISOCABTAGENE MARALEUCEL TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA AND SECONDARY CENTRAL NERVOUS SYSTEM LYMPHOMA: INITIAL RESULTS FROM TRANSCEND NHL 001
Author(s): ,
Jeremy Abramson
Affiliations:
Massachusetts General Hospital Cancer Center,Boston,United States
,
M. Lia Palomba
Affiliations:
Memorial Sloan Kettering Cancer Center,New York,United States
,
Jon Arnason
Affiliations:
Beth Israel Deaconess Medical Center,Boston,United States
,
Matthew Lunning
Affiliations:
University of Nebraska Medical Center,Omaha,United States
,
Scott Solomon
Affiliations:
Blood and Marrow Transplant Group of GA,Atlanta,United States
,
Thalia Farazi
Affiliations:
Juno Therapeutics, a Celgene Company,Seattle,United States
,
Jacob Garcia
Affiliations:
Juno Therapeutics, a Celgene Company,Seattle,United States
,
Benhuai Xie
Affiliations:
Juno Therapeutics, a Celgene Company,Seattle,United States
,
Kathryn Newhall
Affiliations:
Celgene,Summit,United States
,
Christine Dehner
Affiliations:
Juno Therapeutics, a Celgene Company,Seattle,United States
Tanya Siddiqi
Affiliations:
City of Hope National Medical Center,Duarte,United States
EHA Library. Abramson J. Jun 14, 2019; 266098; PF298
Jeremy Abramson
Jeremy Abramson
Contributions
Abstract

Abstract: PF298

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
No clinical studies have yet evaluated chimeric antigen receptor (CAR) T cell therapies in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who have secondary central nervous system (CNS) lymphoma. 

Aims
To report data from patients with secondary CNS lymphoma receiving lisocabtagene maraleucel (liso-cel; JCAR017), an investigational, anti-CD19 CAR T cell product administered as a defined composition of CD4+/CD8+ CAR T cells, in the phase 1 TRANSCEND NHL 001 study.

Methods
Eligible patients had confirmed B-cell NHL with R/R disease after ≥2 prior lines of therapy. Patients with secondary CNS lymphoma were eligible as long as they also had systemic disease or, if it developed on study, patients could continue to receive liso-cel. After lymphodepleting chemotherapy, liso-cel was administered at 1 of 2 dose levels; 50 × 106 total CAR+ T cells (dose level 1) or 100 × 106 total CAR+ T cells (dose level 2). Efficacy was evaluated per the Lugano criteria. Patients achieving a complete response could be retreated with liso-cel upon progressive disease.

Results
At the data cutoff, 9 patients with secondary CNS lymphoma at initial treatment (n=6), retreatment (n=2), or cycle 2 (n=1) received liso-cel. Four patients were treated at dose level 1 and 5 at dose level 2. The median (range) age was 60 (47‒73) years and the number of prior lines of therapy was 3 (2‒7). Median (range) time to peak CAR+ T cell expansion was 12.5 (7–112) days. One of 9 patients had grade 2 cytokine release syndrome (CRS) and 1 of 9 patients had a neurological event (NE; grade 3 decreased level of consciousness). No retreatment patients had CRS or NE, however, 1 retreatment patient had an NE of grade 2 temporal edema during the initial treatment with liso-cel. Five patients received prophylactic levetiracetam. One patient received corticosteroids and tocilizumab. Other toxicities were predominantly cytopenias. There were no treatment-related deaths. Four patients responded to liso-cel; all with a best response of complete response, of which 2 are ongoing at 270 and 545 days post-liso-cel. All 4 responses occurred after initial liso-cel treatment; no retreated patients responded.

Conclusion
In the ongoing TRANSCEND NHL 001 study, liso-cel continues to demonstrate the ability to be safely delivered to patients with R/R B-cell NHL, including those with secondary CNS lymphoma, a population of patients with a highly unmet medical need. No excess NE was noted in this population. This cohort continues to be evaluated.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): CD19, Cellular therapy, Diffuse large B cell lymphoma

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