KITE’S CAR T-CELL THERAPY DATA SHOW REAL-WORLD PATIENT BENEFIT AND DURABLE RESPONSE ACROSS DIFFICULT-TO-TREAT BLOOD CANCERS

– 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 –

Stockley Park, UK – 12 June 2025 – 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.[i] 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).[ii] 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.2

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.[iii]

“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.”

Abstract Information:

About ZUMA-7

ZUMA-7 is a randomised, open-label, global, multicentre (US, Australia, Canada, Europe, Israel) Phase 3 study of 359 patients at 77 centres, evaluating the safety and efficacy of a single-infusion of axicabtagene ciloleucel versus current standard of care (SOC) for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose chemotherapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. The primary endpoint is event free survival (EFS). Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes (PROs) and safety.

About ZUMA-3

ZUMA-3 is an international multicentre (US, Canada, Europe), single arm, open label, registrational Phase 1/2 study of brexucabtagene autoleucel in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete haematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allogeneic stem cell rate were assessed as secondary endpoints.

About ZUMA-2

ZUMA-2 is a single-arm, international multicentre, open-label, Phase 2 study of brexucabtagene autoleucel in adult patients (≥18 years old) with relapsed or refractory mantle cell lymphoma (MCL) who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The primary endpoint is the objective response rate per the Lugano Classification (2014), defined as the combined rate of CR and partial responses as assessed by an Independent Radiologic Review Committee (IRRC).

About Yescarta (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.[i] 

About Tecartus (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.[ii]

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.

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. 

Forward-Looking Statements 

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavourable results from ongoing or additional clinical trials involving axicabtagene ciloleucel and brexucabtagene autoleucel; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel and brexucabtagene autoleucel; Kite’s ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of axicabtagene ciloleucel and brexucabtagene autoleucel, and the risk that any such approvals may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing axicabtagene ciloleucel and brexucabtagene autoleucel; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.