– Long-Term Analysis Shows Similar Safety and Effectiveness Outcomes in Outpatient vs. Inpatient Setting with Positive Impact for Healthcare Systems –
June 1, 2025--SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced real-world data evaluating the safety and effectiveness of Yescarta® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital. The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. The results were shared in a presentation (Abstract #7023) during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
“The encouraging results from this study corroborate reports from treatment centers and prior studies in the real world that illustrate the potential feasibility of administering axi-cel in the outpatient setting for people with relapsed or refractory large B-cell lymphoma,” said Dr. Fateeha Furqan, lead investigator, The University of Texas MD Anderson Cancer Center. “Outpatient administration of axi-cel has cost-effective advantages over inpatient treatment, including less burden on hospitals. These clinical results reflect the fact that the knowledge and experience needed to safely administer the therapy has only grown since axi-cel was first approved in 2017.”
Data were collected from the CIBMTR observational database (between July 2021 to Nov 2023). The final analysis assessed data on patients with R/R LBCL from 75 treatment centers, comparing 119 individuals who were assigned to receive Yescarta in the outpatient setting to 119 patients assigned to receive Yescarta in the inpatient setting. With a median follow-up of 12 months, no general differences were found between the 2 groups in the rates of cytokine release syndrome, neurologic events or immune effector cell-associated neurotoxicity syndrome grade ≥ 3.
Almost one-fourth of 119 patients who were assigned to receive Yescarta in the outpatient setting did not require hospital admission within 30 days, and half of 119 patients did not require hospital admission within 3 days based on propensity score-matched dataset. These real-world data are not currently in the U.S. Prescribing Information.
"We are seeing a growing body of evidence that suggests outpatient administration of Yescarta could be reliable and safe in suitable settings, with benefits for the patient, their family and healthcare system,” said Dominique Tonelli, M.D., Vice President and Global Head of Medical Affairs, Kite. “We are confident that these promising results will help inform providers to expand the number of patients who can achieve the curative potential of a one-time treatment with Yescarta.”
Patients assigned to the outpatient and inpatient treatment groups were matched by age, sex, comorbidities, lactate dehydrogenase (LDH), bulky disease, prior lines of therapy, chemosensitivity and infusion year. Patients assigned to the outpatient group had a median age of 63 years (25% ≥ 70), 66% were male and 67% had ≥ 1 comorbidity. Half had elevated LDH and 73% had 1 prior line of therapy. Bulky disease was reported in 3% and 60% had chemo-resistant disease.
About LBCL
Globally, LBCL is the most common type of non-Hodgkin lymphoma. In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.
About Yescarta
Please see full Prescribing Information, including BOXED WARNING below and Medication Guide.
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017.