OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB chimeric antigen receptor (CAR) T-cell product approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We present the OUTREACH primary analysis, evaluating the safety and efficacy of outpatient monitoring after liso-cel treatment at community sites in the United States. Adults with R/R LBCL after ≥2 prior lines of therapy received liso-cel. Outpatient vs inpatient monitoring was per investigator discretion. The primary end points were incidences of grade ≥3 cytokine release syndrome (CRS), neurological events (NEs), prolonged cytopenia, and infections. Efficacy was a secondary end point. Eighty-two patients received liso-cel (outpatient monitored, 70%; inpatient monitored, 30%). The median follow-up was 10.6 months (range, 1.0-24.5). In outpatients and inpatients, grade ≥3 CRS occurred in 0% and 0%, NEs in 12% and 4%, infections in 12% and 8%, and prolonged cytopenia in 33% and 32%, respectively. Among outpatients, 25% were never hospitalized after infusion, and 32% were hospitalized ≤72 hours after the day of infusion; the median time to hospitalization was 5.0 days (range, 2-310). The median initial hospitalization duration after liso-cel was 6.0 days (range, 1-28) for outpatients and 15.0 days (range, 3-31) for inpatients. Objective response rate was 80%, complete response rate was 54%, and the median duration of response was 14.75 months (95% confidence interval, 5.0 to not reached). OUTREACH is, to our knowledge, the first and largest study to prospectively assess CAR T-cell therapy with outpatient monitoring in community-based medical centers. Liso-cel demonstrated meaningful efficacy with favorable safety in patients with R/R LBCL. Data support the feasibility of liso-cel administration at community sites with outpatient monitoring. This trial was registered at www.ClinicalTrials.gov as #NCT03744676.
Source: Blood Advances
Authors: Yuliya Linhares, Cesar O. Freytes, Mohamad Cherry, Carlos Bachier, Michael Maris, Daanish Hoda, Juan C. Varela, Courtney Bellomo, Scott Cross, James Essell, Suzanne Fanning, Howard Terebelo, Habte Yimer, Jay Courtright, Jeff P. Sharman, Ana Kostic, Min Vedal, Ken Ogasawara, Ariel Avilion, Ricardo Espinola, Brenda Yuan, Bassam Mattar
Institutions: Baptist Hospital of Miami, Houston Methodist, Methodist Hospital, Sarah Cannon, Methodist Hospital, Methodist Hospital, Atlantic Health System, Colorado Blood Cancer Institute, Intermountain Healthcare, Orlando Health, AdventHealth Orlando, New York Oncology Hematology, Virginia Oncology Associates, Oncology Hematology Care, Prisma Health, Ascension Providence Hospital, Texas Oncology, Medical City Dallas Hospital, Willamette Valley Cancer Institute and Research Center, Bristol-Myers Squibb (United States), Cancer Center of Kansas
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W4402985477