Yuliya Linhares, MD, discusses the trial design, methodology, and key efficacy and safety results from the phase 2 OUTREACH trial (NCT03744676) evaluating lisocabtagene maraleucel (liso-cel; Breyanzi) in relapsed/refractory large B-Cell lymphoma (LBCL).
Yuliya Linhares, MD, medical oncologist, chief of Lymphoma Services, Miami Cancer Institute, discusses the trial design, methodology, and key efficacy and safety results from the phase 2 OUTREACH trial (NCT03744676) evaluating lisocabtagene maraleucel (liso-cel; Breyanzi) in relapsed/refractory large B-Cell lymphoma (LBCL).
The non-randomized study assessed patient-reported outcomes and health-related quality of life (QOL) to determine if they were maintained throughout the administration of liso-cel in outpatient vs inpatient community sites.
Over half of patients enrolled in the trial were 65 years of age or older and over 90% were refractory to previous therapy. A total of 79 patients were treated with liso-cel in the third line or later. Inpatient vs outpatient monitoring of patients was at the investigator's discretion and patients were primarily selected for inpatient monitoring according to high tumor burden, risk of adverse events (AEs), and psychosocial risk factors.
Treatment with liso-cel led to consistent safety results and robust efficacy in both outpatient and inpatient community settings, Linhares says. The most common grade 3 or higher TEAE was cytopenia. No grade 5 treatment-emergent AEs (TEAEs) were reported, and the incidence of severe cytokine release syndrome (CRS) and neurological events was low in both settings, she notes. The overall response rate was 80%, with a 54% complete response rate, Linhares continues. After a median follow-up of 17.35 months, the median duration of response was 14.7 months.
Additionally, patients reported meaningfully improved or maintained health-related QOL with liso-cel compared with their baseline evaluation, Linhares says. Disease-associated parameters such as role functioning, fatigue, and pain were particularly improved with liso-cel, she notes.
These results indicate that the administration of liso-cel in non-medical community centers is both safe and effective for this patient population, Linhares says. Patients with LBCL who are eligible for CAR T-cell therapy often experience delays in treatment, which leads to poorer outcomes, Linhares explains. Therefore, incorporating outpatient liso-cel infusion and monitoring into clinical practice could expand access to CAR T-cell therapy, thereby improving patient outcomes, she concludes.
Editor’s Note: Dr. Linhares reports serving as a consultant or in an advisory role for Glaxosmithkline, ADC therapeutics, Gilead Sciences, Inc., BeiGene USA, Seagen, Bristol-Meyers Squibb, Genentech, Abbvie, TG therapeutics, Kyowa Kirin, AstraZeneca, Celgene, Incyte, Janssen, Novartis ; she reports receiving research funding from ADC therapeutics, BeiGene USA, Seagen, Bristol-Meyers Squibb, Genentech ; she reports serving on the board of directors for Alexion, Genentech, AstraZeneca, Celgene, Kyowa Kirin, Incyte, Janssen, Novartis; she reports participating in workshops with Curio Science