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

– 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 –

Stockley Park, UK – 9 April 2024 – 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.[1] The analysis will be shared via an oral presentation on Tuesday 16 April 2024 during the 50^th Annual EBMT Meeting in Glasgow, United Kingdom.

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).¹ 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.¹

“We are pleased to present these data at the 50^th 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 6 to 10 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.[2]

The following Kite spokespeople are available:

• Dick Sundh, Vice President, Head of ACE, Kite
• Dominique Tonelli, Executive Director, Head of Medical Affairs, ACE, Kite

For more information or to arrange an interview contact Cressida Robson on +44 7341 789 204 or cressida.robson@gilead.com. 

About Brexucabtagene Autoleucel

In December 2020, the European Commission (EC) granted conditional Marketing Authorisation for brexucabtagene autoleucel, the first CAR T-cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. In August 2022, the EC approved brexucabtagene autoleucel for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.[3]

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.^[4]