OUTREACH Study Found Outpatient Monitoring for Liso-cel to Be Feasible

Chimeric antigen receptor T-cell therapy administration is considered part of inpatient (IP) care due to concerns of adverse event (AE) management. Data from the OUTREACH study (NCT03744676), which evaluated lisocabtagene maraleucel (liso-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) across outpatient (OP) and IP settings in the United States, were presented at the 64th American Society of Hematology Annual Meeting and Exposition.

Adults with R/R LBCL after ≥2 lines of therapy and Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1 were enrolled at community sites. Patients with grade 3-4 cytopenias, secondary central nervous system (CNS) lymphoma, and prior autologous stem-cell transplant were eligible. Liso-cell infusions were given after leukapheresis and lymphodepleting chemotherapy. OP versus IP monitoring was left to investigator discretion. Study sites had a multidisciplinary team and standard operating procedures (SOPs) for OP monitoring of toxicity and admission for cytokine release syndrome (CRS) and/or neurologic event (NE) management. The primary end point was incidence of grade ≥3 CRS, NEs, prolonged cytopenias (unresolved at day 29), and infections, while secondary end points included AEs, overall response rate (ORR), complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

At data cutoff, 82 patients received liso-cel, with 57 patients (70%) monitored in the OP setting and 25 (30%) in the IP setting. Median age was 66 years (range, 28-86; ≥65 years, 54%), with 61% of patients having diffuse LBCL not otherwise specified, 67% having baseline ECOG PS of 1, and 2% having secondary CNS lymphoma. Patients received a median of 2 prior lines of systemic therapy (range, 2-6), 83% were refractory to chemotherapy, and 54% received bridging therapy. The most common reasons for IP monitoring were disease characteristics and psychosocial factors. No grade ≥3 CRS was reported, with grade ≥3 NEs occurring in 10% of patients; 29% of patients received tocilizumab and/or corticosteroids for CRS or NEs. In OPs and IPs, any-grade CRS was reported in 37% and 48%, any-grade NEs in 28% and 32% (grade ≥3 in 12% and 4%), any-grade infections in 33% and 32% (grade ≥3 in 12% and 8%), and grade ≥3 prolonged cytopenias in 33% and 32%, respectively.

For OPs, 25% of patients were never hospitalized post-infusion, 32% were hospitalized for ≤4 days post-infusion, and median time to hospitalization was 5 days; reasons for hospital admission were AEs (61%) and other (14%). ICU admissions occurred in 1 OP (2%) after initial hospitalization for 5 days versus 2 IPs (8%) for a median duration of 5.5 days (range, 4-7). Median duration of initial hospital stay after liso-cel infusion was 6.0 days for OPs versus 15.0 days for IPs. Regarding efficacy, an ORR of 80% and a CR rate of 54% were observed. Median (m)DOR was 14.75 months (mo; 95% confidence interval [CI], 5.0-not reached [NR]; median follow-up, 17.35 mo), mPFS was 5.8 mo (95% CI, 3.0-15.6), and mOS was NR (95% CI, 10.6-NR). Similar efficacy outcomes were observed among OPs and IPs.

Patients with R/R LBCL treated with liso-cel were successfully infused and monitored as OPs in the community setting using SOPs and multidisciplinary teams. Shorter hospital stays in OPs versus IPs suggest healthcare burden could be reduced by OP monitoring at qualified sites, potentially resulting in lower total costs. Overall, these data support feasible liso-cel treatment at community sites and monitoring in the OP setting.

Source

Linhares Y, Freytes C, Cherry M, et al. Results from OUTREACH: a phase 2 study of lisocabtagene maraleucel administered as outpatient or inpatient treatment in the community/nonuniversity setting in patients with relapsed or refractory large B-cell lymphoma. Presented at: 64th American Society of Hematology Annual Meeting and Exposition, December 10-13, 2022; New Orleans, LA. Poster presentation 4673.