According to an analysis of three studies evaluating lisocabtagene maraleucel (liso-cel) presented at the 2020 Transplantation & Cellular Therapy Meetings, treatment with the outpatient chimeric antigen receptor (CAR) T-cell therapy is safe and effective for patients with relapsed/refractory large B-cell lymphoma.
Researchers reviewed outcomes from 37 patients enrolled in the TRANSCEND NHL 001, PILOT, and OUTREACH studies who received liso-cel on an outpatient basis after undergoing lymphodepletion with fludarabine/cyclophosphamide. A total of 16 patients experienced any-grade cytokine release syndrome (CRS) and 12 had any-grade neurologic events. Two of the neurologic events were grade 3 or 4, and both were considered reversible. There were no grade 5 treatment-related adverse events (AEs) reported for patients treated in outpatient settings.
Fifteen of the 37 patients (41%) did not require hospitalization in the first 29 days after liso-cel infusion. The authors also reported that incidence of early hospitalization after liso-cel infusion was low: 3 patients (8%) were admitted to the hospital on day 3 or earlier (all related to CRS).
Liso-cel infusion also appeared to be effective, with 76% of patients across the studies achieving an objective response, including 55% who achieved complete responses.
“Currently, the 40 to 50 patients who have been treated in the outpatient setting suggest that this therapy can be delivered safely in [this] setting,” said lead investigator Carlos R. Bachier, MD, from TriStar Centennial Medical Center in Nashville, Tennessee. However, these results will need to be confirmed in larger trials.
Sources: , March 30, 2020; Bachier CR, Abramson JS, Sehgal A, et al. 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. Abstract #29. Presented at the Transplantation & Cellular Therapy Meetings, February 19, 2020; Orlando, FL.