Outpatient Treatment with Lisocabtagene Maraleucel (liso-cel) in 3 Ongoing Clinical Studies in Relapsed/Refractory (R/R) Large B Cell Non-Hodgkin Lymphoma (NHL), Including Second-Line Transplant Noneligible (TNE) Patients: Transcend NHL 001, Outreach, and PILOT

ObjectivesCAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access. We report on patients (pts) with R/R large B cell NHL treated with liso-cel in the outpatient setting in TRANSCEND NHL 001 (NCT02631044) and two phase 2 studies (≥3rd-line therapy: OUTREACH, NCT03744676; 2nd-line TNE: PILOT, NCT03483103).MethodsEligible pts had R/R large B cell NHL (TRANSCEND/OUTREACH: ≥2 lines of prior therapy and ECOG PS ≤1; PILOT: 1 line of prior therapy and deemed TNE for autologous hematopoietic stem cell transplant based on ECOG PS, organ function, or age). After lymphodepletion with fludarabine/cyclophosphamide, liso-cel was administered. All studies allowed outpatient treatment at nonuniversity (OUTREACH) or university and nonuniversity medical centers (TRANSCEND/PILOT), with hospitalization at the first sign of fever or neurological events (NEs) per management guidelines.ResultsAt data cutoff, 37 pts across studies received liso-cel on study Day 1 and were monitored as outpatients, including pts aged ≥65 years (n = 15) and those with SPD ≥50 cm2 (n = 10) or LDH ≥500 UL (n = 2). Results are shown in the Table. Sixteen pts had any grade cytokine release syndrome (CRS) and 12 had any grade NEs (19 pts had CRS and/or NEs). Only 2 pts had had grade 3 or 4 CRS or NEs, which were reversible. Three pts received tocilizumab and corticosteroids for CRS and/or NEs; none received tocilizumab alone. Overall, 59% of pts (n = 22/37) required hospitalization at any time; all were from TRANSCEND or OUTREACH. Of 37 pts, 3 (8%) were admitted on study Day 3 or earlier (all for CRS) and 1 (3%) required ICU-level care (length of stay, 3 days). Median time to hospitalization post treatment was 5 (range, 2‒22) days; median length of stay was 6 (range, 2‒23) days. Overall, 41% of pts (15/37), including all 5 pts from PILOT, did not require hospitalization in the first 29 days post liso-cel infusion. Across all studies, most pts achieved an objective response (76%), including complete responses.ConclusionsA subset of pts with R/R large B cell NHL were successfully treated with liso-cel and monitored for CAR T cell–related toxicity in the outpatient setting, including elderly pts and pts with high tumor burden. Incidences of severe CRS, NEs, and early hospitalization were low; 41% of pts did not require hospitalization in the first month post treatment. Most pts achieved an objective response. CAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access. We report on patients (pts) with R/R large B cell NHL treated with liso-cel in the outpatient setting in TRANSCEND NHL 001 (NCT02631044) and two phase 2 studies (≥3rd-line therapy: OUTREACH, NCT03744676; 2nd-line TNE: PILOT, NCT03483103). Eligible pts had R/R large B cell NHL (TRANSCEND/OUTREACH: ≥2 lines of prior therapy and ECOG PS ≤1; PILOT: 1 line of prior therapy and deemed TNE for autologous hematopoietic stem cell transplant based on ECOG PS, organ function, or age). After lymphodepletion with fludarabine/cyclophosphamide, liso-cel was administered. All studies allowed outpatient treatment at nonuniversity (OUTREACH) or university and nonuniversity medical centers (TRANSCEND/PILOT), with hospitalization at the first sign of fever or neurological events (NEs) per management guidelines. At data cutoff, 37 pts across studies received liso-cel on study Day 1 and were monitored as outpatients, including pts aged ≥65 years (n = 15) and those with SPD ≥50 cm2 (n = 10) or LDH ≥500 UL (n = 2). Results are shown in the Table. Sixteen pts had any grade cytokine release syndrome (CRS) and 12 had any grade NEs (19 pts had CRS and/or NEs). Only 2 pts had had grade 3 or 4 CRS or NEs, which were reversible. Three pts received tocilizumab and corticosteroids for CRS and/or NEs; none received tocilizumab alone. Overall, 59% of pts (n = 22/37) required hospitalization at any time; all were from TRANSCEND or OUTREACH. Of 37 pts, 3 (8%) were admitted on study Day 3 or earlier (all for CRS) and 1 (3%) required ICU-level care (length of stay, 3 days). Median time to hospitalization post treatment was 5 (range, 2‒22) days; median length of stay was 6 (range, 2‒23) days. Overall, 41% of pts (15/37), including all 5 pts from PILOT, did not require hospitalization in the first 29 days post liso-cel infusion. Across all studies, most pts achieved an objective response (76%), including complete responses. A subset of pts with R/R large B cell NHL were successfully treated with liso-cel and monitored for CAR T cell–related toxicity in the outpatient setting, including elderly pts and pts with high tumor burden. Incidences of severe CRS, NEs, and early hospitalization were low; 41% of pts did not require hospitalization in the first month post treatment. Most pts achieved an objective response.