Real-World Evidence Supports Outpatient Axicabtagene Ciloleucel (Yescarta) Administration for Relapsed/Refractory LBCL

Sawyer Bawek, DO University at Buffalo

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting was full of groundbreaking research, innovative therapies, and real-world evidence aimed at transforming cancer care. One important study shared was Abstract 7023, “Trends and outcomes by inpatient and outpatient infusion of axicabtagene ciloleucel (axi-cel) in the US for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).” The abstract highlights the safety and efficacy of Yescarta (axicabtagene ciloleucel) when administered in an outpatient setting as compared with an inpatient setting for patients with R/R LBCL.

Study Design and Patient Cohort

Data were obtained from an observational database (Center for International Blood and Marrow Transplant Research [CIBMTR]) from July 2021 to November 2023 across 75 treatment centers. Researchers examined 238 patients with R/R LBCL, who were evenly matched, with 119 treated as outpatients and 119 as inpatients. Matching factors included age, sex, comorbidities, lactate dehydrogenase (LDH) levels, bulky disease, prior lines of therapy, chemosensitivity, and year of infusion to account for a balanced comparison. Patients with prior allogeneic transplant were excluded. 

The outpatient cohort had a median age of 63 years, comprising 66% male, 67% with at least one comorbidity, 50% with elevated LDH, 73% who had one prior line of therapy, 3% with bulky disease, and 60% who were chemoresistant. Outcomes were analyzed at a median follow-up of 12 months. The study evaluated critical end points of safety (rates of cytokine release syndrome [CRS], neurologic events, and immune effector cell-associated neurotoxicity syndrome [ICANS] grade ≥3), efficacy, and resource utilization.

Key Findings: Comparable Outcomes, Similar Safety Profiles, Potentially Reduced Hospital Burden

Multivariate analyses showed no significant difference between intended care setting and CRS, CRS grade ≥3, neurologic events, or neurologic events grade ≥3. Additionally, nearly 25% of patients avoided hospital admission within 30 days postinfusion, while 50% avoided hospital admission within the first 3 days. As mentioned, safety profiles showed no significant differences in adverse events between CRS, neurologic events, or ICANS grade ≥3. 

The results suggest that outpatient administration of Yescarta can be given in an outpatient setting, potentially improving access to the therapy without compromising patient safety. Additionally, Yescarta in the outpatient setting may reduce the burden on hospitals and improve cost-effectiveness. 

Implications for Oncology Practice: Expanding Access to Curative Therapy

The results highlight the potential option for outpatient centers to adopt or establish protocols for eligible patients to receive Yescarta in the outpatient setting. Appropriate patient selection remains critical, focusing on patients without high-risk features for severe toxicity. Future studies may help refine these findings or validate them, potentially expanding options for future cell therapy delivery. 

For more in-depth coverage of the meeting’s key takeaways, visit our other blogs at OncUpdates.com on ASCO 2025, which include recaps of major abstracts, expert interviews, and emerging trends in hematology and oncology.

Stay tuned to OncUpdates for more updates from future ASCO and ASH conferences. What are your thoughts on outpatient CAR T-cell therapy? Share in the comments below.