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In the first and largest study to prospectively assess chimeric antigen receptor (CAR) T-cell therapy with outpatient monitoring in community medical centers, lisocabtagene maraleucel (liso-cel) administered at these sites demonstrated meaningful efficacy with a positive safety profile in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), according to results published in Blood Advances.1
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CAR-T therapy is an effective treatment option for R/R patients, though pursuing this therapeutic option can be difficult for patients and caregivers who may need to take some time off work to receive treatment or find temporary accommodations far from home. Furthermore, the therapy comes with potentially significant adverse effects, such as cytokine release syndrome (CRS) and damage to the brain.2
“Transferring patients to a new health system can cause headaches for obtaining insurance approvals, arranging appointments, and ensuring continuity of care,” Yuliya Linhares, MD, chief of the lymphoma service at Miami Cancer Institute and study author, said in a news release. Because of these obstacles, Linhares and her team initiated the OUTREACH trial (NCT03744676) to evaluate the feasibility of administering CAR-T therapy on an outpatient basis.2,3
OUTREACH, an open-label, multicenter, phase 2 study, was conducted at community centers, which was defined as nontertiary care centers not associated with a university. A patient was deemed an outpatient if liso-cel was administered in the outpatient facility, or in the inpatient facility with same-day discharge. The primary end point was the incidence of grade 3 or higher AEs of special interest (AESI).1
From November 2018 to December 2021, 82 patients received liso-cel. Of these, 57 patients were monitored in the outpatient setting and 25 patients were monitored in the inpatient setting, at the investigator’s discretion. Common any-grade treatment-emergent AEs (TEAEs) were neutropenia, leukopenia, CRS, thrombocytopenia, and anemia—however, the incidence of grade 3 or higher TEAEs was generally similar between outpatients and inpatients (74% vs 76%, respectively).1
Importantly, these safety results were similar for both outpatient and inpatient settings. Overall, they were also consistent with results from previously conducted studies and historical liso-cel data, “further demonstrating the consistent and favorable safety profile of liso-cel” in the trial.1
Across all 82 patients treated with liso-cel, the overall response rate (ORR) was 80% (n = 66; 95% CI, 70.3-88.4), with similar ORR observed in outpatient (82% [95% CI, 70.1-91.3]) and inpatient (76% [95% CI, 54.9-90.6]) settings. The total population complete response (CR) rate was 54% (95% CI, 42.3-64.7); among patients with a first response or partial response (PR; n = 36), 14 patients (39%) later achieved a best response of CR. These included 8 outpatients and 6 inpatients.1
A major strength of the trial was the utilization of medical sites that represent diverse types of community medical centers. These included both single-entity and dual-entity sites, those with and without Foundation for the Accreditation of Cellular Therapy (FACT) accreditation, and sites with and without previous experience in administering CAR T-cell therapy.1
Trial Name: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)
ClinicalTrials.gov ID: NCT03744676
Sponsor: Juno Therapeutics, a Subsidiary of Celgene
Study Completion Date: September 22, 2023
“I’m very excited to see this therapy offered to a wider range of patients,” Linhares said in the news release. “It is important to show that this therapy can be safely given not just in university-based medical centers, but also in community medical centers, and that it can be given not only in an inpatient setting but also in an outpatient setting.”2
The investigators listed some study limitations that may have affected the results. Tumor burden may have been higher for patients treated on an inpatient basis. Furthermore, the study was not designed to support comparisons between inpatient and outpatient; OUTREACH was not randomized, and inpatient individuals were decided based on the discretion of the investigator and their clinical needs.1,2
“These findings support liso-cel treatment at community medical centers using standard operating procedures and multidisciplinary teams with outpatient monitoring in appropriate patients,” the investigators concluded.1
