Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025

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11/03/2025 - 09:10 AM

– Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally –

– New Findings Reinforce Yescarta’s^® Curative Potential as Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma –

– Next-Generation CAR T-cell Therapies Suggest High Response Rates and Encouraging Durability in B-Cell Malignancies –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 21 abstracts, including 5 oral presentations, during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition (December 6-9). These data showcase Kite’s continued progress in transforming blood cancer care and expanding the reach and impact of CAR T-cell therapy.

“Kite is dedicated to advancing cell therapy as a path to cures, and our data at ASH will reflect meaningful progress toward this goal,” said Cindy Perettie, Executive Vice President of Kite. “Together with our partner Arcellx, we’ll unveil the updated results from the pivotal Phase 2 iMMagine-1 study. These findings will lay the foundation for our aspiration with anito-cel to deliver a differentiated treatment for relapsed/refractory multiple myeloma with strong potential for community oncology access and reduced burden on patients and caregivers.”

Anito-cel Data Updates

Key presentations for anitocabtagene autoleucel (anito-cel) include updated results from the fully enrolled, ongoing iMMagine-1 Phase 2 pivotal study. No delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune-mediated enterocolitis, have been observed to date.

Data on Next-Generation Pipeline

Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753. These therapies are designed to target two antigens (CD19 and CD20) found on cancer cells and use two co-stimulatory domains (CD28 and 4-1 BB) to help the immune system fight cancer more effectively. This dual-targeting approach may lower the chance of the cancer escaping treatment and could also improve safety, making it possible to treat patients outside of a hospital setting.

Survival Outcomes with Yescarta^® Based on ASCT Eligibility

A key presentation for Yescarta^® (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible. Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment.

Dates and times are listed in ET for the following accepted abstracts and presentations:

Oral Presentations
Abstract Details	Titles
*Axicabtagene Ciloleucel Clinical Data*
Abstract #671 Sunday, December 7, 2025 5:30 PM – 5:45 PM OCCC – Tangerine Ballroom F3-4	Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) for Second-Line High-Risk Large B-Cell Lymphoma (LBCL): Interim Results from a Phase 1b Study
*Brexucabtagene Autoleucel Clinical Data*
Abstract #569 Sunday, December 7, 2025 1:00 PM – 1:15 PM OCCC – Tangerine Ballroom F3-4	ZUMA-25 Preliminary Analysis: A Phase 2 Study of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Burkitt Lymphoma (BL), Substudy C
*Anitocabtagene Autoleucel Clinical Data*
Abstract #256 Saturday, December 6, 2025 2:45 PM – 3:00 PM OCCC – West Halls D1	Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Updated Results from iMMagine-1
*Kite Next Generation CAR T Clinical Data*
Abstract #265 Saturday, December 6, 2025 2:00 PM – 2:15 PM OCCC – West Halls D2	A Phase 1 Study of KITE-753 or KITE-363 in Patients with Relapsed/Refractory B-Cell Lymphoma: Initial Safety and Preliminary Efficacy of KITE-753 and Updated Results of KITE-363
*Translational Medicine*
Abstract #805 Monday, December 8, 2025 10:30 AM – 10:45 AM OCCC – W331	Blood and CSF Metabolomics Identifies Tryptophan Catabolism and Polyamine Synthesis as Drivers of CAR T-Cell-Associated Neurotoxicity
Poster Presentations
*Axicabtagene Ciloleucel*
Abstract #1799 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4	Patient Journey with Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma in Canada: Manufacturing experience and Impact of Patient Location to Treatment Centre
Abstract #3714 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Axi-Cel Delivers Similar Outcomes Regardless of ASCT-Eligibility in Second Line R/R LBCL: Combined Data from ZUMA-7 and ALYCANTE
Abstract #1894 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4	Diffuse Large B Cell Lymphoma in Brazil: Understanding the Patient Journey to Improve Healthcare Assistance
Abstract #4510 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Estimating the Survival Impact of Not Receiving CAR T-cell (CAR T) Therapy When Eligible in Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the United States (US)
Abstract #6194 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	US Cost Consequence and Time Toxicity Model for Advanced Therapies in the Treatment for Relapsed/Refractory Third-line or Later Diffuse Large B-cell Lymphoma: A Comparison of Axicabtagene Ciloleucel with Bispecific Antibodies
Abstract #5356 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Real-World Effectiveness and Safety Outcomes by Age, Comorbidity, Frailty, and Treatments Prior to Infusion in Relapsed or Refractory (R/R) Follicular Lymphoma Patients Treated with Axicabtagene Ciloleucel
Abstract #3717 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Surrogate Endpoints as Prognostic Factors for Long-Term Outcomes Among Patients Receiving Axicabtagene Ciloleucel in Frontline High-risk Large B Cell Lymphoma
Abstract #4503 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Real-World Treatment Patterns and Survival Outcomes in Second and Third Line Settings in Large B-cell Lymphoma (LBCL)
*Brexucabtagene Autoleucel*
Abstract #1588 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4	Endogenous Regulation of Inflammatory Response as a Determinant of Durable Remission Without Stem Cell Transplant Following Brexucabtagene Autoleucel (Brexu-Cel) Therapy in ALL
Abstract #1799 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4	Two-year Update of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Had Not Received Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy
Abstract #3606 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Real-world Effectiveness and Safety Outcomes by Age, Comorbidities, and Frailty Among Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients Treated with Brexucabtagene Autoleucel (Brexu-Cel)
*Above Brand*
Abstract #5882 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Pre-Treatment CD19 Antigen Density and Multi-Antigen Profiling by Calibrated Quantitative Flow Cytometry Correlates with CAR T Efficacy in LBCL
*Multiple Myeloma Unmet Clinical Need*
Abstract #6344 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Visualizing Geographic Variation and Systemic Inequities of Disease Burden and CAR T-Cell Therapy Access in Multiple Myeloma in the US
Abstract #6284 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Outcomes of Inpatient and Outpatient Chimeric Antigen Receptor T-cell Therapy (CAR T) in Newly Authorized Treatment Centers (ATCs) in the United States (US)
Abstract #4411 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4	Real-world Healthcare Resource Utilization (HCRU) Following CAR T-Cell Therapy in US Patients Treated in Newly Authorized Treatment Centers
Publication Only: Anitocabtagene Autoleucel Pre-Clinical Data
Abstract #7644	The Fast Off-Rate of Anito-cel’s D-Domain Binder Contributes to Its Distinctive Pharmacology Profile in Preclinical Models of Multiple Myeloma
Investigator-Sponsored / Collaboration: Anitocabtagene Autoleucel Pre-Clinical Data*
Oral Abstract #203 Sunday, December 7, 2025 10:30 AM – 10:45 AM OCCC – Sunburst Room (W340)	Single-cell Transcriptomics Reveal Mechanisms of Efficacy and Toxicity in Anti-BCMA CAR-T Cell Therapies for Multiple Myeloma

For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2025/webprogram/start.html

*Presentations independently led and sponsored feature Kite CAR T-cell therapies but are not included in total number of Kite accepted abstracts.

About Yescarta

INDICATIONS

YESCARTA^®is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

U.S. IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.

CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

HYPERSENSITIVITY REACTIONS

Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) in:

patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.
patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.
patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

About Gilead and Kite Oncology

Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

About Arcellx and Kite Collaboration

Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.

About Anitocabtagene autoleucel (anito-cel)

Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signalling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

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 ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta, anito-cel, KITE-363 and KITE-753; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; 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 June 30, 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.

Yescarta, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.

U.S. Prescribing Information for Yescarta, including BOXED WARNING, is available at www.kitepharma.com.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X/Twitter (@KitePharma) and LinkedIn (Kite-Pharma).