OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL.

Autor:	Linhares Y; Baptist Health, Miami Cancer Institute, Miami, FL., Freytes CO; Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital, San Antonio, TX., Cherry M; Department of Hematology Oncology/Medical Oncology, Atlantic Health System, Carol Simon Cancer Center, Morristown, NJ., Bachier C; Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital, San Antonio, TX., Maris M; Department of Hematology/Oncology, Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO., Hoda D; Intermountain Healthcare, Loveland Clinic for Blood Cancer Therapy, Salt Lake City, UT., Varela JC; Advent Health, Orlando, FL., Bellomo C; New York Oncology Hematology, Albany, NY., Cross S; Virginia Oncology Associates, Norfolk, VA., Essell J; Oncology Hematology Care, Cincinnati, OH., Fanning S; Prisma Health, Greenville, SC., Terebelo H; Ascension Providence Hospital, Southfield, MI., Yimer H; Texas Oncology-Tyler, Tyler, TX., Courtright J; Texas Oncology, Medical City Dallas, Dallas, TX., Sharman JP; Willamette Valley Cancer Institute, Eugene, OR., Kostic A; Bristol Myers Squibb, Seattle, WA., Vedal M; Bristol Myers Squibb, Seattle, WA., Ogasawara K; Bristol Myers Squibb, Princeton, NJ., Avilion A; Bristol Myers Squibb, Seattle, WA., Espinola R; Bristol Myers Squibb, San Diego, CA., Yuan B; Bristol Myers Squibb, Princeton, NJ., Mattar B; Cancer Center of Kansas, Wichita, KS.
Jazyk:	angličtina
Zdroj:	Blood advances [Blood Adv] 2024 Dec 10; Vol. 8 (23), pp. 6114-6126.
DOI:	10.1182/bloodadvances.2024013254
Abstrakt:	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. (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
Databáze:	MEDLINE
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