MONDAY, Oct. 7, 2024 (HealthDay News) -- For patients with relapsed/refractory large B-cell lymphoma (LBCL), the autologous, CD19-directed, 4-1BB chimeric antigen receptor T-cell product, lisocabtagene maraleucel (liso-cel), is safe for outpatients and inpatients and is efficacious, according to a study published online Sept. 30 in Blood Advances.
Yuliya Linhares, M.D., from the Miami Cancer Institute, and colleagues examined outpatient safety and efficacy following liso-cel treatment at community sites in the United States among adults with relapsed/refractory LBCL after two or more prior lines of therapy. Eighty-two patients received liso-cel (70 percent outpatient-monitored; 30 percent inpatient-monitored) and were followed for a median of 10.6 months.
The researchers found that grade 3 or higher cytokine release syndrome occurred in 0 and 0 percent of outpatients and inpatients, respectively; neurological events occurred in 12 and 4 percent; infections in 12 and 8 percent; and prolonged cytopenia in 33 and 32 percent. Twenty-five percent of outpatients were never hospitalized after infusion and 32 percent were hospitalized within 72 hours after the day of infusion; the median time to hospitalization was 5.0 days. After liso-cel, median initial hospitalization duration was 6.0 and 15.0 days for outpatients and inpatients, respectively. The objective response rate and complete response rate were 80 and 54 percent, respectively; the median duration of response was 14.75 months.
"These findings support liso-cel treatment at community medical centers using standard operating procedures and multidisciplinary teams with outpatient monitoring in appropriate patients," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Bristol Myers Squibb, which manufactures liso-cel and funded the study.
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