Outpatient treatment with lisocabtagene maraleucel feasible for certain patients with non-Hodgkin lymphoma
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ORLANDO — Patients with relapsed or refractory large B-cell non-Hodgkin lymphoma can be successfully treated and monitored in the outpatient setting with the chimeric antigen receptor T-cell therapy lisocabtagene maraleucel, according to study results presented at TCT | Transplantation & Cellular Therapy Meetings.
The results — based on a review of findings from three ongoing clinical studies — showed this approach is feasible even for elderly patients and those with high tumor burden, Carlos R. Bachier, MD, director of cellular research at Sarah Cannon Blood Cancer Network, said during a presentation.
“CAR T-cell therapy has generally been limited to inpatient treatment and monitoring for side effects at university medical centers. However, most patients in the United States with relapsed or refractory large B-cell lymphoma receive therapy at non-university medical centers, where delivery of cancer therapy is common in an outpatient infusion center,” Bachier said. “Infusion and monitoring of patients receiving CAR T-cell therapy in the outpatient setting may lead to wider utilization and improved access.”
Bachier and colleagues examined data from three ongoing clinical studies — TRANSCEND-NHL-001, OUTREACH and PILOT — to evaluate outpatient treatment with lisocabtagene maraleucel (JCAR017, Bristol-Myers Squibb), an investigational autologous anti-CD19 CAR T-cell therapy often called liso-cel, for 44 patients with relapsed or refractory large B-cell NHL.
Eighteen were aged 65 years or older, 12 had sum of the products of diameters of at least 50 cm2 and six had lactate dehydrogenase of at least 500 U/L.
All three studies allowed outpatient treatment, with hospitalization at the first sign of neurological events or fever.
All patients in the TRANSCEND and OUTREACH trials had received at least two lines of prior therapy and had ECOG performance status of 1 or lower. Patients in PILOT had received one prior therapy and were considered noneligible for hematopoietic stem cell transplantation based on ECOG performance status, organ function or age.
All patients received liso-cel after lymphodepletion with fludarabine/cyclophosphamide.
Twenty patients developed cytokine release syndrome (n = 17) and/or neurological events (n = 13). Researchers reported one case of grade 3 or higher cytokine release syndrome and two cases of grade 3 or higher neurological events.
Median time to onset was 5 days for cytokine release syndrome and 8 days for neurological events. Median duration of cytokine release syndrome was 6 days, and median duration of neurological events was 16 days.
Three patients received tocilizumab (Actemra; Genentech) and corticosteroids for cytokine release syndrome, two received corticosteroids only, and none received tocilizumab alone.
Seven patients (16%) developed grade 3 or higher infections, and nine patients (20%) developed prolonged grade 3 or higher cytopenias.
Twenty-four patients (54.5%) — all from the TRANSCEND or OUTREACH trials — required hospitalization.
Median time to hospitalization was 5 days (range, 2-22) and median length of stay was 6.5 days (range, 2-23).
Most hospitalizations were due to cytokine release syndrome (32%) or other adverse events (23%).
Two patients required ICU admission after liso-cel administration; one patient stayed for 3 days and the other stayed for 5 days.
No grade 5 adverse events occurred among those treated as outpatients.
Researchers reported an 80% overall response rate among all patients treated and monitored in the outpatient setting; these included 24 (55%) complete responses and 11 (25%) partial responses.
Three patients (7%) achieved stable disease and five (11%) experienced progressive disease. One patient (2%) was not evaluable for efficacy.
“Outpatient administration of liso-cel and subsequent monitoring were successfully implemented in multiple clinical trials at both university and non-university sites,” Bachier said during a presentation. “Safety and efficacy [among] outpatients were consistent with that observed in the total [third-line-or-later] large B-cell lymphoma population in TRANSCEND-NHL-001. ... Outpatient administration and monitoring of liso-cell are continuing to be evaluated across these trials.” – by Mark Leiser
Reference: Bachier CR, et al. Abstract 29. Presented at: TCT | Transplantation & Cellular Therapy Meetings; Feb. 19-23, 2020; Orlando.
Disclosures: Bachier reports consultant/advisory roles with Allovir, Autolus, Celgene, CRISPR, Novartis and Wugen. Please see the abstract for all other authors’ relevant financial disclosures.
Perspective
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Mazyar Shadman, MD
We have two FDA-approved CAR T-cell therapies for large B-cell lymphoma, and we think liso-cell will be another option in that setting for patients who have undergone more than two lines of treatment. We certainly need to consider efficacy and safety, but access is certainly another important factor. This study shows is definitely is feasible to use a CD19-targeted CAR T-cell therapy in the outpatient setting.
I was very interested in the rate of hospitalization, the reasons for it and the median length of stay. It is important when you talk with patients about the caregiver requirements that the likelihood of admission beyond day 14 or day 21 is low.
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