Primary results from a study of the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel) for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) appear to support the use of this agent in the community setting, including with outpatient monitoring. The findings were presented in a poster at the SOHO 2023 Annual Meeting by Yuliya Linhares, MD, of Baptist Health at the Miami Cancer Institute in Miami, Florida, and colleagues.
The phase 2 OUTREACH trial (ClinicalTrials.gov Identifier: NCT03744676) enrolled patients with R/R LBCL at US community sites for treatment with liso-cel in the third line or later line of therapy.
The study had a primary endpoint of the incidence of grade 3 or higher cytokine-release syndrome (CRS), neurological events, prolonged cytopenias at day 29, and infections. Multiple secondary endpoints were also evaluated, such as adverse events (AEs), the objective response rate (ORR), the complete response (CR) rate, the duration of response (DOR), and others.
There were 82 patients treated with liso-cel in this analysis, among whom 57 received outpatient monitoring and 25 received inpatient monitoring. Patients had a median age of 66 years (range, 28-86) overall. The median number of prior therapies was 2 (range, 2-6). Most patients (83%) had chemotherapy-refractory disease.
Across the total population, there was an ORR of 80%, and the CR rate was 54%. The median DOR was 14.75 months. The ORRs were 82% among outpatients and 76% among inpatients, with CR rates of 58% and 44%, respectively. The median follow-up time was 17.35 months, with a median follow-up time since liso-cel infusion of 10.6 months (range, 1.0-24.5).
There were 33 deaths reported in this study, mostly attributed to disease progression, whereas 5 deaths were attributed to AEs, none of which were considered treatment-emergent AEs.
Treatment-emergent AEs of any grade were most commonly neutropenia in 67%, leukopenia in 44%, CRS in 40%, thrombocytopenia in 35%, anemia in 33%, and fatigue in 30%. There were no cases of CRS of grade 3 or higher reported. Neurological events of any grade were reported in 29% of patients, and at grade ≥3 in 10%. Grade ≥3 prolonged cytopenia at day 29 was reported in 33% of patients overall, and grade ≥3 infections were reported in 11%. Treatment-emergent AEs of grade ≥3 were reported in 74% of outpatients and 76% of inpatients.
After liso-cel infusion, 75% of outpatients became hospitalized. Patients had median durations of initial hospitalization after infusion of 6.0 days (range, 1-28) among outpatients and 15.0 days (range, 3-31) among inpatients.
In this study of patients treated in the community setting, the investigators considered liso-cel to have shown efficacy and safety outcomes that were consistent with the findings of the TRANSCEND study. They also considered the safety profile to be manageable and found the study to support the feasibility of liso-cel treatment at community centers and with outpatient monitoring.
Disclosures: This research was supported by Juno Therapeutics. Please see the original reference for a full list of disclosures.
Linhares Y, Freytes C, Cherry M, et al. Primary results from OUTREACH: a phase ii study of lisocabtagene maraleucel (liso‑cel) administered in the community setting as outpatient or inpatient treatment in patients with relapsed or refractory (R/R) large B‑cell lymphoma (LBCL). Presented at: the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO) ; September 6-9, 2023. Abstract CT-045.