Kite Presents New Data for Yescarta (axicabtagene ciloleucel) CAR T-cell Therapy Highlighting Manufacturing Excellence and Cost-Effectiveness in the US
February 21, 2024 – BioManufacturing – CAR T-cell, CGTs, Gilead Sciences, Kite Pharma, manufacturing
- Data Highlights Industry-leading Manufacturing Success Rates for US Axicabtagene Ciloleucel Patients from Launch to Present
- Data Also Supports Cost-effectiveness of Axicabtagene Ciloleucel Versus Bispecific Antibodies
16 February 2024 – Stockley Park, UK – Kite, a Gilead Company, will present new data for Yescarta (axicabtagene ciloleucel) at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, 21-24 February 2024, in San Antonio, US.
“It is our goal to help ensure that as many eligible patients as possible have the opportunity to have long-term survival with axicabtagene ciloleucel. Our rapid and reliable industry-leading manufacturing process can help achieve this,” said Ibrahim Elhoussieny, VP, Medical Affairs, Kite. “The data at this year’s Tandem Meetings reflect Kite’s commitment to continuously improve treatment with axicabtagene ciloleucel for clinicians and their patients living with large B-cell lymphoma, whose disease can progress rapidly.”
New data includes:
Axicabtagene Ciloleucel Manufacturing Data
This real-world data analyses more than 6,000 relapsed/refractory (R/R) large B-cell lymphoma (LBCL) patients in the US who received axicabtagene ciloleucel from launch in 2018 to May 2023. The results highlight the industry-leading manufacturing success rate (96%) and median turnaround (16 days) for axicabtagene ciloleucel in the US. The ability to manufacture and disposition patient lots within specification at the first attempt is critical to maintaining a timely and dependable manufacturing process. A supporting analysis of the commercial manufacturing experience for patients with LBCL treated in the second-line in the real-world setting showed a manufacturing success rate consistent with the ZUMA-7 pivotal study (99% and 100%, respectively).
Efforts such as axicabtagene ciloleucel’s recent US Food and Drug Administration (FDA) approved manufacturing process change, which will reduce the median turnaround time from 16 to 14 days in the US, will further optimise the axicabtagene ciloleucel manufacturing process and improve delivery times for patients.
Axicabtagene Ciloleucel Cost Effectiveness Data
This data supports the cost-effectiveness of axicabtagene ciloleucel vs epcoritamab and glofitamab – both bispecific antibodies (BsAbs) – in the third-line setting for patients with diffuse large B-cell lymphoma (DLBCL), based on a subset of clinical trial data and simulated models.
For more information, including a complete list of abstract titles at the 2024 Tandem Meetings Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, please visit: https://tandem.confex.com/tandem/2024/meetingapp.cgi/Home/0
About Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a CD19-directed genetically modified autologous CAR T-cell therapy, approved by the European Commission (EC) for the treatment of adult patients with 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 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.
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.
