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– iMMagine-1 Data Provide 18 Months Minimum Follow-Up on Anito-cel’s Durability and Safety in Relapsed or Refractory Multiple Myeloma –
– Five-Year ZUMA-12 Follow-Up Data to Provide Long-Term Evidence for Yescarta® in First-Line High-Risk Large B-cell Lymphoma –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced 23 presentations, including 7 oral presentations, will be presented at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition (December 12–15, 2026).
These latest clinical milestones demonstrate transformative progress across Gilead and Kite’s pipeline and portfolio, from new data for the investigational anitocabtagene autoleucel (anito-cel) in relapsed or refractory (RR) multiple myeloma (MM), to early clinical results from our next-generation approaches in lymphoma and autoimmune blood disorders, and long-term follow-up data supporting standard-of-care therapies.
"People living with blood cancers deserve treatments that offer more than a response; they deserve the possibility of lasting freedom from disease,” said Gallia Levy, MD, PhD, Senior Vice President, Global Head of Development at Kite. “The data we are presenting reflect the breadth of our leadership and our commitment to advancing next-generation cell therapy, so more patients can benefit across multiple cancers and throughout their treatment journey."
Key presentations at ASH 2026
Deepening and Expanding Clinical Evidence for Anito-cel in MM: Anito-cel is an investigational CAR T-cell therapy for the treatment of RRMM. At ASH, Kite will present 18-month minimum follow-up results from the pivotal Phase 2 iMMagine-1 open-label, single-arm, multicenter study of anito-cel in people who received three or more prior lines of therapy, including treatments from all three major drug classes for MM, alongside new comparative and collaborative research in the disease.
• iMMagine-1 (4L+ RRMM): Maturing efficacy data, including progression-free survival (PFS) and overall survival (OS) analyses, alongside updated safety outcomes, from the pivotal Phase 2 open-label, single-arm study of anito-cel in RRMM. Data from the iMMagine-1 trial are the basis of the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) submission, which is under review with a Prescription Drug User Fee Act (PDUFA) target date of December 23, 2026.
• Comparative Analyses (RRMM): New matching-adjusted indirect comparison (MAIC) analyses examining the efficacy and safety of anito-cel versus bispecific antibodies and other CAR T-cell therapies.
• GEM-AnitoFIRST (Newly Diagnosed MM): Data from the open-label, non-randomized Phase 2 study being conducted in collaboration with the PETHEMA Foundation (Programa Español de Tratamiento en Hematología) evaluating anito-cel in newly diagnosed MM.
Expanding Real-World Use and Long-Term Evidence Underscore the Track Record for Yescarta®:
• ZUMA-12 (1L High-Risk LBCL): Five-year follow-up from the first prospective Phase 2, single-arm, open-label study evaluating Yescarta ®(axicabtagene ciloleucel) as a first-line treatment for high-risk large B-cell lymphoma (LBCL) patients who remain positron emission tomography (PET)-positive after two cycles of chemoimmunotherapy.
• Real-World Evidence: Expanding real-world data, including outcomes from the French collaborative group The Lymphoma Study Association/Lymphoma Academic Research Organization (LYSA/LYSARC) (DESCAR-T) registry across established and newly authorized treatment centers, and Canadian data assessing the feasibility and safety of outpatient CAR T administration.
• GELTAMO LATE-R: Second interim analysis of the Phase 2, single-arm, open-label study of axicabtagene ciloleucel in patients with late-relapsing LBCL after completing first-line chemoimmunotherapy (CIT).
Initial Global Clinical Experience with Investigational Gamgertamig (CM336/OM336) in Relapsed/Refractory Autoimmune Cytopenias (AICs): Gilead and Lakefront Biotherapeutics (Lakefront) are collaborating to advance programs in inflammation, including the development of gamgertamig (CM336/OM336), an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibody-driven, immune-mediated disease. New data from two ongoing Phase 1b studies will provide initial clinical experience with short-course subcutaneous gamgertamig, administered over a maximum of three weeks in people with relapsed or refractory AICs.
• Immune Thrombocytopenia (ITP): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory ITP, a rare autoantibody-driven disease that causes platelet destruction and increased bleeding risk.
• Autoimmune Hemolytic Anemia (AIHA): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory AIHA, a rare autoantibody-driven disease that causes destruction of red blood cells leading to anemia.
Dates and times are listed in CT for the following accepted abstracts and presentations:
Abstract Details | Titles
Oral Presentations
Anitocabtagene Autoleucel
Abstract #273Saturday, December 122:30 – 2:45 PMMCCNO – La Nouvelle C | Updated Analysis of iMMagine-1, a Phase 2 Registrational Study of Anitocabtagene Autoleucel (Anito-cel) for the Treatment of Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM)
Abstract #6579Saturday, December 129:30 – 9:45 AMMCCNO – Hall E | Anitocabtagene Autoleucel Following Induction Therapy in Newly Diagnosed Multiple Myeloma: Early Safety, Response, and MRD Results from the Phase 2 GEM-AnitoFIRST Study*Collaboration with PETHEMA Foundation
Axicabtagene Ciloleucel
Abstract #1031Monday, December 145:30 – 5:45 PMMCCNO – New Orleans Theatre A | Axicabtagene Ciloleucel as Second-line Treatment for Late-relapsed Aggressive Large B-cell Lymphoma: Second Interim Analysis of the GELTAMO LATE-R Phase II Trial*Collaboration with GELTAMO
Abstract #614Saturday, December 1212:15 – 12:30 PMMCCNO – New Orleans Theatre C | Real-world Outcomes After Axicabtagene Ciloleucel as 2nd- vs 3rd-line Therapy in Large B-cell Lymphoma: A Propensity Score-matched Analysis from the French DESCAR-T Registry*Collaboration with LYSA/LYSARC
Abstract #613Sunday, December 1312:00 – 12:15 PMMCCNO – New Orleans Theatre C | A Prospective Clinical Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma
Abstract #703Sunday, December 134:30 – 4:45 PMMCCNO – New Orleans Theatre B | Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) as Second-line Therapy for High-risk Relapsed or Refractory Large B-cell Lymphoma: Results from the Phase 1b ENCORE-1 Trial
Additional CAR T-Cell Therapy
Abstract #1056Monday, December 145:45 – 6:00 PMMCCNO – 388-390 | Armored TmCD19-IL18 CAR T cells in patients with CD19+ lymphomas
Poster Presentations
Anitocabtagene Autoleucel
Abstract #4042Sunday, December 136:00 – 8:00 PMMCCNO – Hall F | Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (anito-cel) vs Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up
Abstract #4043Sunday, December 136:00 – 8:00 PMMCCNO – Hall F | Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up
KITE-753
Abstract #5944Monday, December 146:00 – 8:00 PMMCCNO – Hall F | Response Durability and Early Immune Cell Recovery: Updated Results from the Phase 1 Multicenter PALISADES-1 Study of KITE-753 in Relapsed/Refractory B-cell Lymphoma
Axicabtagene Ciloleucel
Abstract #1912Saturday, December 125:30 – 7:30 PMMCCNO – Hall F | 5-year Follow-up of the Phase 2 ZUMA-12 Study of Axicabtagene Ciloleucel (Axi-cel) as First-line Therapy in Patients (Pts) with High-risk Large B-cell Lymphoma (LBCL)
Abstract #2632Saturday, December 125:30 – 7:30 PMMCCNO – Hall F | Feasibility of Outpatient Axicabtagene Ciloleucel (Axi-cel) for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Centre Analysis in Canada
Abstract #2728Saturday, December 125:30 – 7:30 PMMCCNO – Hall F | Audit of the Uptake of Second Line Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma in the Welsh Population with Assessment of the Impact of Deprivation on Access to and Response Following First Line Chemoimmunotherapy
| Impact of Fludarabine Exposure Levels During Lymphodepletion on the Efficacy and Toxicity of Axicabtagene Ciloleucel in Large B-cell Lymphoma: A Multicenter Retrospective Study
Brexucabtagene Autoleucel
Abstract #5081Monday, December 146:00 – 8:00 PMMCCNO – Hall F | Brexucabtagene Autoleucel as Consolidation Therapy in Adult Patients with High-risk Philadelphia (Ph)-negative B-cell Acute Lymphoblastic Leukemia
| Real-world outcomes after second CD19-directed CAR T cell treatment for relapsed/refractory B cell acute lymphoblastic leukemia
| CD19-directed CAR T-cell therapy with brexucabtagene autoleucel or obecabtagene autoleucel produces durable remission for CML patients in lymphoid blast phase: A Rocca consortium multicenter analysis
| High Efficacy of Obe-cel and Brexu-cel in Patients with Extramedullary B-ALL
Additional CAR T-Cell Therapy
Abstract #4107Sunday, December 136:00 – 8:00 PMMCCNO – Hall F | Depth of Lymphodepletion, Measured by IL-15 Serum Levels, as a Modifiable Risk Factor for Neurotoxicity and Non-relapse Mortality: Results from Large-scale Protein Screening Across 710 Patients Treated with Anti-CD19 CAR T Cell Therapy
| Access to CAR T cell therapy for adults with multiple myeloma or large B-cell lymphoma: Patient, caregiver, and clinician perspectives
Gamgertamig
Abstract #3008Sunday, December 136:00 – 8:00 PMMCCNO – Hall F | Initial global clinical experience with gamgertamig (CM336/OM336), a BCMAxCD3 T‑cell engager, in relapsed/refractory autoimmune cytopenias (AICs) in two parallel ongoing studies (NCT07083960, NCT07175493)*Collaboration with Lakefront
Publication Only
Abstract #7562 | Real-world (RW) Outcomes of Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-cel) in Non-Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) Accredited Centers in France from the DESCAR-T Registry
Abstract Details
Titles
Oral Presentations
Anitocabtagene Autoleucel
Abstract #273
Saturday, December 12
2:30 – 2:45 PM
MCCNO – La Nouvelle C
Updated Analysis of iMMagine-1, a Phase 2 Registrational Study of Anitocabtagene Autoleucel (Anito-cel) for the Treatment of Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM)
Abstract #6579
Saturday, December 12
9:30 – 9:45 AM
MCCNO – Hall E
Anitocabtagene Autoleucel Following Induction Therapy in Newly Diagnosed Multiple Myeloma: Early Safety, Response, and MRD Results from the Phase 2 GEM-AnitoFIRST Study*
Collaboration with PETHEMA Foundation
Axicabtagene Ciloleucel
Abstract #1031
Monday, December 14
5:30 – 5:45 PM
MCCNO – New Orleans Theatre A
Axicabtagene Ciloleucel as Second-line Treatment for Late-relapsed Aggressive Large B-cell Lymphoma: Second Interim Analysis of the GELTAMO LATE-R Phase II Trial*
Collaboration with GELTAMO
Abstract #614
Saturday, December 12
12:15 – 12:30 PM
MCCNO – New Orleans Theatre C
Real-world Outcomes After Axicabtagene Ciloleucel as 2nd- vs 3rd-line Therapy in Large B-cell Lymphoma: A Propensity Score-matched Analysis from the French DESCAR-T Registry*
Collaboration with LYSA/LYSARC
Abstract #613
Sunday, December 13
12:00 – 12:15 PM
MCCNO – New Orleans Theatre C
A Prospective Clinical Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma
Abstract #703
Sunday, December 13
4:30 – 4:45 PM
MCCNO – New Orleans Theatre B
Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) as Second-line Therapy for High-risk Relapsed or Refractory Large B-cell Lymphoma: Results from the Phase 1b ENCORE-1 Trial
Additional CAR T-Cell Therapy
Abstract #1056
Monday, December 14
5:45 – 6:00 PM
MCCNO – 388-390
Armored TmCD19-IL18 CAR T cells in patients with CD19+ lymphomas
Poster Presentations
Anitocabtagene Autoleucel
Abstract #4042
Sunday, December 13
6:00 – 8:00 PM
MCCNO – Hall F
Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (anito-cel) vs Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up
Abstract #4043
Sunday, December 13
6:00 – 8:00 PM
MCCNO – Hall F
Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up
KITE-753
Abstract #5944
Monday, December 14
6:00 – 8:00 PM
MCCNO – Hall F
Response Durability and Early Immune Cell Recovery: Updated Results from the Phase 1 Multicenter PALISADES-1 Study of KITE-753 in Relapsed/Refractory B-cell Lymphoma
Axicabtagene Ciloleucel
Abstract #1912
Saturday, December 12
5:30 – 7:30 PM
MCCNO – Hall F
5-year Follow-up of the Phase 2 ZUMA-12 Study of Axicabtagene Ciloleucel (Axi-cel) as First-line Therapy in Patients (Pts) with High-risk Large B-cell Lymphoma (LBCL)
Abstract #2632
Saturday, December 12
5:30 – 7:30 PM
MCCNO – Hall F
Feasibility of Outpatient Axicabtagene Ciloleucel (Axi-cel) for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Centre Analysis in Canada
Abstract #2728
Saturday, December 12
5:30 – 7:30 PM
MCCNO – Hall F
Audit of the Uptake of Second Line Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma in the Welsh Population with Assessment of the Impact of Deprivation on Access to and Response Following First Line Chemoimmunotherapy
Impact of Fludarabine Exposure Levels During Lymphodepletion on the Efficacy and Toxicity of Axicabtagene Ciloleucel in Large B-cell Lymphoma: A Multicenter Retrospective Study
Brexucabtagene Autoleucel
Abstract #5081
Monday, December 14
6:00 – 8:00 PM
MCCNO – Hall F
Brexucabtagene Autoleucel as Consolidation Therapy in Adult Patients with High-risk Philadelphia (Ph)-negative B-cell Acute Lymphoblastic Leukemia
Real-world outcomes after second CD19-directed CAR T cell treatment for relapsed/refractory B cell acute lymphoblastic leukemia
CD19-directed CAR T-cell therapy with brexucabtagene autoleucel or obecabtagene autoleucel produces durable remission for CML patients in lymphoid blast phase: A Rocca consortium multicenter analysis
High Efficacy of Obe-cel and Brexu-cel in Patients with Extramedullary B-ALL
Additional CAR T-Cell Therapy
Abstract #4107
Sunday, December 13
6:00 – 8:00 PM
MCCNO – Hall F
Depth of Lymphodepletion, Measured by IL-15 Serum Levels, as a Modifiable Risk Factor for Neurotoxicity and Non-relapse Mortality: Results from Large-scale Protein Screening Across 710 Patients Treated with Anti-CD19 CAR T Cell Therapy
Access to CAR T cell therapy for adults with multiple myeloma or large B-cell lymphoma: Patient, caregiver, and clinician perspectives
Gamgertamig
Abstract #3008
Sunday, December 13
6:00 – 8:00 PM
MCCNO – Hall F
Initial global clinical experience with gamgertamig (CM336/OM336), a BCMAxCD3 T‑cell engager, in relapsed/refractory autoimmune cytopenias (AICs) in two parallel ongoing studies (NCT07083960, NCT07175493)*
Collaboration with Lakefront
Publication Only
Abstract #7562
Real-world (RW) Outcomes of Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-cel) in Non-Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) Accredited Centers in France from the DESCAR-T Registry
*Kite collaborative or investigator-initiated studies
For remaining presentation information, please visit: https://www.hematology.org/Meetings/Annual-Meeting
About Yescarta & Tecartus
YESCARTA (axicabtagene ciloleucel) and TECARTUS (brexucabtagene autoleucel) are genetically modified autologous T-cell immunotherapies that use a patient’s own T cells, which are modified ex vivo to express a chimeric antigen receptor (CAR) designed to recognize CD19. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they recognize and kill CD19-expressing target cells.
U.S. Indications for YESCARTA and TECARTUS
YESCARTA is indicated for the treatment of adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy; adult patients with relapsed or refractory (R/R) LBCL 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; and adult patients with R/R follicular lymphoma (FL) after two or more lines of systemic therapy. The FL indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial.
TECARTUS is indicated for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and adult patients with R/R B-cell precursor acute lymphoblastic leukemia (ALL).
U.S. Important Safety Information for YESCARTA and TECARTUS
BOXED 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 or TECARTUS. Do not administer YESCARTA or TECARTUS 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 or TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA or TECARTUS. 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.
YESCARTA Warnings and precautions
• Serious hypersensitivity reactions may occur during YESCARTA infusion. Monitor patients for hypersensitivity reactions during infusion.
• Severe or life-threatening infections occurred in patients 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 or higher 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 YESCARTA infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of patients with NHL after YESCARTA infusion 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 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, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) 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 YESCARTA infusion.
• Hypogammaglobulinemia: B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment with YESCARTA and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
• 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. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483).
YESCARTA Adverse reactions
• The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. The most common Grade 3-4 laboratory abnormalities (≥ 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia.
YESCARTA Dosage and administration
For autologous use only. For intravenous use only.
• Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The target YESCARTA dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells.Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of YESCARTA.
• Premedication: Premedicate with acetaminophen and an H1-antihistamine.
• Confirm availability of tocilizumab andverify the patient’s identity prior to infusion.
• Do NOT use a leukodepleting filter.
• Infuse the entire contents of the YESCARTA bag within 30 minutes of thawing by either gravity or a peristaltic pump. YESCARTA is stable at room temperature for up to 3 hours after thaw.
• Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of YESCARTA.
TECARTUS Warnings and precautions
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including life-threatening reactions, occurred following treatment with TECARTUS. HLH/MAS occurred in 4% (3/78) of patients with ALL. Two patients experienced Grade 3 events, and 1 patient experienced a Grade 4 event. All 3 patients with HLH/MAS had concurrent CRS symptoms and neurologic events after TECARTUS infusion. Treatment of HLH/MAS should be administered per institutional standards.
• Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide or residual gentamicin in TECARTUS.
• Severe or life-threatening infections occurred in patients after TECARTUS infusion. Infections (all grades) occurred in 63% (105/168) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 33% of patients with MCL and 29% of patients with ALL. TECARTUS should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after TECARTUS infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 4% of patients with MCL and 35% of patients with ALL after TECARTUS infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) patients with ALL includes events of “febrile neutropenia” (11 (14%)) plus the concurrent events of “fever” and “neutropenia” (16 (21%)). 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, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies should be considered in 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, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.
• Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 55% (92/168) of patients and included thrombocytopenia (32%), neutropenia (42%), and anemia (14%). In patients with ALL who were responders to TECARTUS treatment, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following TECARTUS infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after TECARTUS infusion.
• Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with TECARTUS. Hypogammaglobulinemia was reported in 14% (23/168) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with TECARTUS and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
• Secondary Malignancies: Patients treated with TECARTUS 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. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483).
TECARTUS Adverse reactions
• The most common non-laboratory adverse reactions (incidence ≥ 20%) are:MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction.ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
• MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction.
• ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
TECARTUS Dosage and administration
For autologous use only. For intravenous use only.
• Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
• MCL: The target TECARTUS dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells.Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of TECARTUS.
• ALL: The target TECARTUS dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells.Pretreatment: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m 2 intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m 2 over 60 minutes on the second day before infusion of TECARTUS.
• Premedication: Premedicate with acetaminophen and an H1-antihistamine.
• Confirm availability of tocilizumab andverify the patient’s identity prior to infusion.
• Do NOT use a leukodepleting filter.
• Infuse the entire contents of the TECARTUS bag within 30 minutes of thawing by either gravity or a peristaltic pump. TECARTUS is stable at room temperature for up to 3 hours after thaw.
• Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of TECARTUS.
• Pretreatment: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m 2 intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m 2 over 60 minutes on the second day before infusion of TECARTUS.
U.S. Full Prescribing Information for YESCARTA and TECARTUS, including BOXED WARNINGS, are available at 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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 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 a novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling 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.
About KITE-753
KITE-753 is an investigational, autologous bicistronic CAR T-cell therapy being evaluated for the treatment of adult patients with relapsed or refractory B-cell lymphoma. Designed to engage two established B-cell targets simultaneously (CD19 and CD20), KITE-753 also combines dual co-stimulatory signaling (CD28 and 4-1BB) to help T-cells respond quickly and stay active over time. Its T-cell optimized manufacturing process is intended to preserve T-cell fitness and enhance durability of complete responses.
About Gamgertamig (CM336/OM336)
Gamgertamig (CM336/OM336) is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibody-driven immune-mediated disease. It has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. Gamgertamig is under an open Investigational New Drug (IND) in the U.S. and is expected to enter registrational studies in 2027. Gamgertamig is being developed in collaboration with Lakefront Biotherapeutics.
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 Tecartus (brexucabtagene autoleucel), Yescarta (axicabtagene ciloleucel), anito-cel, gamgertamig, and KITE-753 (such as iMMagine-1, GEM-AnitoFIRST, LATE-R, and ZUMA-12); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation, such as the BLA for anito-cel in RRMM; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; 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 September 30, 2026, 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, Tecartus, 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 and Tecartus, including BOXED WARNINGS, 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).
Priscilla White, Gilead Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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