Real-World Evidence Demonstrates Feasibility and Safety of Outpatient Administration of Yescarta (axicabtagene ciloleucel)
February 15, 2024 – Clinical Trials – CAR T-cell, GSK, Kite Pharma
- Findings show comparable safety for patients administered axicabtagene ciloleucel in the outpatient setting in the US to inpatient infusion
- Real-world evidence supports further exploration of use of outpatient administration of chimeric antigen receptor T-cell (CAR T-cell) therapy to improve health system capacity.
15 February 2024 — Stockley Park, UK — Kite, a Gilead Company, today announced an analysis of literature from early real-world US evidence that assessed the administration of 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. 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.
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 US. 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.
“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.”
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, US, 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. Visit: www.kitepharma.com.
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, US. Gilead acquired Kite in 2017. Visit: www.gilead.com.
