Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta ® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025

Kite, a Gilead company, announced real-world data at the ASCO 2025 meeting showing that Yescarta (axicabtagene ciloleucel) can be safely and effectively administered to relapsed/refractory large B-cell lymphoma (R/R LBCL) patients in an outpatient setting, with outcomes comparable to inpatient treatment. The CIBMTR registry analysis of 238 patients across 75 treatment centers found no significant differences in rates of cytokine release syndrome or neurologic events between outpatient and inpatient groups, suggesting potential cost-effective advantages and reduced burden on hospitals. Approximately one-fourth of patients assigned to outpatient treatment did not require hospital admission within 30 days of treatment.

Analysis

Kite, a Gilead Company (GILD), presented compelling real-world data at the ASCO 2025 Annual Meeting (Abstract #7023) demonstrating comparable safety and effectiveness of Yescarta (axicabtagene ciloleucel) for relapsed/refractory large B-cell lymphoma (R/R LBCL) when administered in an outpatient versus inpatient setting. The study, utilizing data from the CIBMTR registry between July 2021 and November 2023, analyzed 238 patients (119 outpatient, 119 inpatient) across 75 treatment centers with a median follow-up of 12 months. Crucially, no significant differences were observed in the rates of severe adverse events such as cytokine release syndrome (CRS), neurologic events, or immune effector cell-associated neurotoxicity syndrome (ICANS) grade ≥ 3 between the two cohorts. Notably, almost 25% of patients assigned to outpatient Yescarta administration avoided any hospital admission within 30 days, and 50% avoided admission within 3 days based on propensity score-matched data. These findings suggest the potential for significant cost savings for healthcare systems and reduced hospital burden, reflecting growing expertise in administering axi-cel since its 2017 approval. While this real-world evidence is not yet incorporated into the U.S. Prescribing Information, it supports the feasibility of expanding Yescarta access through outpatient administration, potentially enhancing its market penetration and patient convenience for this one-time treatment.

Key Decisions for Investors

• Investors should view these positive data as potentially expanding the addressable market and improving the cost-effectiveness profile for Yescarta, which could favorably impact Gilead's oncology franchise revenues and margins.
• Monitor for further updates from regulatory bodies regarding the inclusion of outpatient administration data in Yescarta's U.S. Prescribing Information, as this would formalize and likely accelerate the shift towards outpatient treatment.
• Consider the operational efficiencies and competitive advantages Gilead might gain if outpatient Yescarta administration becomes standard practice, but also remain aware of Yescarta's detailed safety profile, including its BOXED WARNING for CRS and neurologic toxicities, which necessitate careful patient selection and management even in an outpatient setting.