REAL-WORLD EVIDENCE DEMONSTRATES FEASIBILITY AND SAFETY OF OUTPATIENT ADMINISTRATION OF YESCARTA® (AXICABTAGENE CILOLEUCEL)
– Findings Show Comparable Safety for Patients Administered Axicabtagene Ciloleucel in the Outpatient Setting in the U.S. to Inpatient Infusion –
– Real-World Evidence Supports Further Exploration of use of Outpatient Administration of Chimeric Antigen Receptor T-cell therapy to Improve Health System Capacity –
Stockley Park, UK – 15 February 2024 – Kite, a Gilead Company, today announced an analysis of literature from early real-world U.S. evidence that assessed the administration of Chimeric Antigen Receptor (CAR) T-cell therapy Yescarta® (axicabtagene ciloleucel) in the outpatient setting, with comparable safety outcomes to those receiving inpatient infusion. These findings support further exploration of outpatient CAR T-cell therapy administration to improve capacity and resource utilisation across healthcare systems.1 The real-world analysis was presented today at the 6th European CAR T-cell Meeting, 15-17 February 2024, Valencia, Spain.
Results from the analysis showed post-infusion hospitalisation rates for patients receiving CAR T-cell therapy in an outpatient setting were 50-92% overall and 23-85% within 3-days of infusion. The most common reason for hospitalisation was fever and length of stay was 7-14 days. Rates of any grade/grade 3+ cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were 57-92%/2-5% and 29-54%/5-20%, respectively. Mortality ranged from 0 to 29% (median follow-up, 30-393 days) mostly due to progression.1
The systemic literature review included data from over 300 patients treated with CAR T-cell therapy from ten observational studies across nine centres in the United States. Outpatient practice reported varied across centres but typically included close monitoring onsite or close to treatment centres for at least the first 14 days post-infusion. Some centres also utilised wearable devices or telemedicine.1
“These findings provide important insights for treating physicians and healthcare authorities on the use of CAR T-cell therapy in the outpatient setting. This is important to support stretched healthcare systems around the world and helps ensure that patients in need of further treatment options get the care they need,” said Dominique Tonelli MD, Executive Director, Head of Medical Affairs, ACE, Kite. “We are committed to delivering equitable access to CAR T-cell therapy to people with difficult-to-treat blood cancers who currently face a poor prognosis and we support the investigation of efficiencies and innovations to deliver this.”
The following Kite spokespeople are available:
- Dominique Tonelli, Executive Director, Head of Medical Affairs, ACE, Kite
- Dick Sundh, Vice President, Head of ACE, Kite
For more information or to arrange an interview contact Cressida Robson on +44 7341 789 204 or cressida.robson@gilead.com.
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Date / Time (CET) |
Abstract Title |
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Date: Friday 16th February 2024 Time: 08:30 Session: Poster Session PE16 |
Feasibility and Safety of Outpatient Administration of Chimeric Antigen Receptor T-cell Therapy (CAR T): A Systematic Literature Review of Early U.S. Experience
Nausheen Ahmed, Usuma Gergis, Christopher Dieyi, Babatunde Adedokun, Clare Spooner, Christine Fu, Fang Sun, Javier Munoz |
For more information, including a complete list of abstract titles at the meeting, please visit: https://cart2024.abstractserver.com/program/#/program/1/horizontal
About Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, approved by the European Commission (EC) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy; adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy; adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.2
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. 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 production 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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017.
