Kite’s CAR T-Cell Therapy Data Show Real-World Patient Benefit and Durable Response Across Difficult-to-Treat Blood Cancers
June 12, 2025 – Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Other, Pharmaceutical – CAR T-Cell therapy, Gilead Sciences, Kite Pharma, clinical trials, haematology, relapsed/refractory large B-cell lymphoma
- Largest Real-World (RW) Analyses of Yescarta® (Axicabtagene Ciloleucel) Show 74% Overall Survival (OS) at 12 Months in Second-Line Relapsed/Refractory Large B-cell Lymphoma (LBCL), Consistent with OS Reported in Pivotal ZUMA-7 Study, across Broader Patient Populations
- Tecartus® (Brexucabtagene Autoleucel) Demonstrates Prolonged Median Overall Survival of 25.6 Months in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (B-ALL) after more than Five Years of Follow-up in the Pivotal ZUMA-3 study.
12 June 2025 — Stockley Park, UK — Kite, a Gilead Company today presents latest results that demonstrate a 79% overall response (ORR) rate and 74% overall survival (OS) at six months follow-up, for Yescarta (axicabtagene ciloleucel) as second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL), from the largest real-world study in this patient population. Grade ≥3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 5% and 23% of patients respectively. Data from the Centre for International Blood and Marrow Transplant Research (CIBMTR) registry show axicabtagene ciloleucel effectiveness and safety profile was maintained in patient populations with hepatic or pulmonary comorbidities. The study was presented at the 2025 European Haematology Association (EHA) Annual Congress, 12-15 June, Milan, Italy, as updated data presented at the American Society of Hematology (ASH) 2024 Congress.
A five-year follow-up from the pivotal, ongoing, international multicentre ZUMA-3 study of Tecartus (brexucabtagene autoleucel) demonstrated a median OS of 25.6 months (n=78, 95% CI, 16.2-60.4) and a five-year OS rate of 40% (95%, CI, 28.4-51.3) in all treated adult patients with relapsed/refractory (R/R) B-cell Acute Lymphoblastic Leukaemia (B-ALL). Survival benefit was seen in a broad patient population regardless of prior treatment or subsequent allogeneic stem cell transplant status. No new safety signals related to brexucabtagene autoleucel were observed.
Real-world global evidence for brexucabtagene autoleucel show response outcomes consistent with the pivotal ZUMA-2 study in patients with mantle cell lymphoma (MCL) across US and European cohorts. A numerically favourable safety profile was observed in the real-world setting versus data reported from ZUMA-2.
“These robust real-world and clinical data add to the growing body of evidence for the outcomes delivered by axicabtagene ciloleucel and brexucabtagene ciloleucel for people living with difficult to-treat blood cancers,” said Dan Tovar, Head of Medical Affairs Cell Therapy, Australia, Canada and Europe (ACE) Region. “We are committed to continuing to understand the transformative potential of CAR T-cell therapy to eligible patients in urgent need of this innovative treatment option.”
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. 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, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. Visit: www.gilead.com.
