Kite to Present Comparison of Outcomes of Tecartus (brexucabtagene autoleucel) from the Pivotal ZUMA-2 Trial Versus the EBMT Registry of alloSCT Patients in Mantle Cell Lymphoma (MCL) at 50th EBMT 2024
April 12, 2024 – Biotechnology, Clinical Trials – EMBT, Gilead Sciences, Kite Pharma, oncology
Additional analysis demonstrates cost-effectiveness of axicabtagene ciloleucel versus standard of care as second-line therapy In patients With large B-cell lymphoma In Italy
9 April 2024 — Stockley Park, UK — Kite, a Gilead Company, announced results from a comparative analysis of outcomes for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who received Tecartus (brexucabtagene autoleucel) in the pivotal ZUMA-2 trial versus allogeneic stem cell transplantation (alloSCT) from the European Society for Blood and Marrow Transplantation (EBMT) database. The analysis will be shared via an oral presentation on Tuesday 16 April 2024 during the 50th Annual EBMT Meeting in Glasgow, UK.
The comparative analysis examined the data of 64 patients with R/R MCL post-Bruton tyrosine kinase inhibitors (BTKi) who received brexucabtagene autoleucel in ZUMA-2, a global, multicentre, single-arm, open-label phase 2 study. Patients were matched with 272 patients who had undergone alloSCT and met eligibility criteria identified in the EBMT registry. The data are presented by the EBMT Lymphoma Working Party (LWP).
The findings showed the long-term overall survival (OS) and progression-free survival (PFS) were similar in both the brexucabtagene autoleucel and matched alloSCT cohort. The analysis found a statistically significant increase in one-year overall survival for brexucabtagene autoleucel versus alloSCT (59.2%, HR 0.39, p=0.004) with a similar median follow-up of 36.5 months (95% CI 34.5-50.1) and 34.1 months (95% CI 26.8-49.8) respectively. Brexucabtagene autoleucel was associated with a lower non-relapse mortality vs alloSCT (7.1% vs 21.2%, p=0.05, respectively). At 36 months the graft-versus-host disease (GvHD) was 16.1% (95% CI 7.8-26.9%) in the brexucabtagene autoleucel groups and 37.3% (95% CI 24.1-50.6%) in the alloSCT groups.
“We are pleased to present these data at the 50th EBMT meeting, which provide insights for the use of brexucabtagene autoleucel as a treatment option for R/R MCL after two lines including BTK inhibitor,” explains Dominique Tonelli MD, executive director, head of Medical Affairs, ACE, Kite. “Survival benefits are an important consideration because this group of patients have a poor prognosis, with a median overall survival of six to ten months. We are committed to build on the body of survival and safety evidence available for the use of CAR T-cell therapies for difficult-to-treat blood cancers.”
A study on the cost-effectiveness of axicabtagene ciloleucel versus standard of care (SOC, salvage chemoimmunotherapy, followed by high-dose therapy with alloSCT) for the treatment of second-line large B-cell lymphoma patients in Italy will also be presented during the annual EBMT meeting. Findings demonstrated that axicabtagene ciloleucel is a cost-effective alternative to SOC in this patient population and can be considered an efficient use of resources in the Italian National Health Service.
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 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.
