– Longer Follow-Up Analyses of Survival Data Showing Curative Intent of Yescarta® To Be Presented Across Lines of Therapy and Age Groups, Including 65+ –
– Durability of Response and Survival With Tecartus® in Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma Observed in Largest Real World Evidence Studies to Date –
– New Clinical Data From Phase 1 Study of CART-ddBCMA in Patients With Relapsed/Refractory Multiple Myeloma To Be Featured in Oral Presentation by Partner Arcellx –
– 29 Abstracts Demonstrate Commitment To Advancing Research Across Spectrum of Blood Cancers –
FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will share 29 presentations, including 10 oral presentations, during the 65th American Society of Hematology (ASH) Annual Meeting and Exposition (December 9-12).
Key presentations for Yescarta (axicabtagene ciloeleucel) in relapsed/refractory (R/R) large B-cell lymphoma (R/R LBCL) across lines of therapy include: three-year results from ZUMA-12 investigating CAR T-cell therapy as part of first-line treatment; ZUMA-7 overall survival sub-group analysis in patients aged 65+; and post-hoc analyses showing the curative intent of Yescarta using six-year follow-up data from ZUMA-1. Additional Yescarta research will focus on new four-year follow-up results from ZUMA-5 evaluating Yescarta in R/R indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma.
“We’re pleased to present new data that continue to support the long-term survival and durability of response of our CAR T-cell therapies in blood cancers, across lines of therapy and age groups,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “Data from our ZUMA-7 sub-analysis will show that Yescarta can help older adults with relapsed/refractory large B-cell lymphoma live longer, underscoring that age is not a barrier to adult patients being treated with CAR T.”
The largest real-world evidence dataset for Tecartus (brexucabtagene autoleucel) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and relapsed/refractory mantle cell lymphoma (R/R MCL) will also be presented. Additionally, four-year overall survival data from ZUMA-2 and a ZUMA-18 primary analysis of expanded access in R/R MCL will be highlighted in an oral presentation.
New data from the Phase 1 study of CART-dd BCMA will be presented from our multiple myeloma partner, Arcellx. CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy with a novel D-Domain BCMA binder that may improve CAR T-cell binding and killing of multiple myeloma cells.
Dates and times* for accepted abstracts and presentations of note are as follows:
*Times listed are in PT
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Oral Presentations |
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Abstract Details |
Titles |
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Large B-cell Lymphoma |
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Abstract #103 Saturday, December 9, 2023 9:30 AM Room 6A |
Real-World Evidence in the United States (US) of the Impact of Bridging Therapy Prior to Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (R/R LBCL) |
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Abstract #223 Saturday, December 9, 2023 2:00 PM Room 6CF |
Baseline Immune State and T-cell Clonal Kinetics are Associated with Response to CAR-T Therapy in Large B-cell Lymphoma*
*In collaboration with Dana Farber Cancer Institute |
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Abstract #226 Saturday, December 9, 2023 2:45 PM Room 6CF |
Pre- and Post-treatment Immune Contexture Correlates with Long Term Response in Large B-cell Lymphoma Patients Treated with Axicabtagene Ciloleucel (Axi-cel)*
*In collaboration with Veracyte |
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Abstract #894 Monday, December 11, 2023 4:00 PM Room 6A |
3-Year Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-cel) as First-Line Therapy in Patients with High-Risk Large B-cell Lymphoma (LBCL) |
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Abstract #224 Saturday, December 9, 2023 2:15 PM Room 6CF |
An Inflammatory Biomarker Signature Reproducibly Predicts CAR T Treatment Failure in Patients with Aggressive Lymphoma Across the ZUMA Trial Cohorts*
*In collaboration with Memorial Sloan Kettering Cancer Center |
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Mantle Cell, Follicular and Other Indolent B-Cell Lymphomas |
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Abstract #106 Saturday, December 9, 2023 10:15 AM Room 6A |
Outcomes of Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated with Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 and ZUMA-18, an Expanded Access Study |
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Abstract #107 Saturday, December 9, 2023 10:30 AM Room 6A |
Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL): A CIBMTR Subgroup Analysis of High-Risk Characteristics |
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Abstract #224 Saturday, December 9, 2023 2:45 PM Room 30 |
Advancing CAR-T Therapy in Acute Lymphoblastic Leukemia: Multi-Omic Analyses of CD19-Directed CAR-T Cells Enabled by an Ex Vivo Co-Culture Platform*
*In collaboration with Lynx Biosciences, Inc. |
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Abstract #1029 Monday, December 11, 2023 5:00 PM Room 6CF |
Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Adult B-cell Acute Lymphoblastic Leukemia (B-cell ALL): Evidence from the CIBMTR Registry |
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Multiple Myeloma |
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Abstract #1023 Monday, December 11, 2023 5:00 PM Room 6A |
Phase 1 Study of CART-ddBCMA for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-year Follow-up in All Patients*
*Led by Kite partner Arcellx |
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Poster Presentations |
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Large B-cell Lymphoma |
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Abstract #1761 Saturday, December 9, 2023 5:30 – 7:30 PM Halls G-H |
Improved Overall Survival with Axicabtagene Ciloleucel vs. Standard of Care in Second-Line Large B-cell Lymphoma Among the Elderly: A Subgroup Analysis of ZUMA-7 |
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Abstract #1638 Saturday, December 9, 2023 5:30 – 7:30 PM Halls G-H |
Personal and Shared Tumor-Antigen Prioritization in Diffuse Large B-cell Lymphoma Patients Undergoing CD19 CAR T-cell Treatment*
*In collaboration with Beth Deaconess Israel Medical Center |
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Abstract #2336 Saturday, December 9, 2023 5:30 – 7:30 PM Halls G-H |
Economic Burden Associated with ASCT in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma: A Nationwide Health Insurance Claims Database Study in Japan During 2012-2022 |
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Abstract #4864 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Curative Potential of Axicabtagene Ciloleucel (Axi-cel): An Exploratory Long-Term Survival Assessment in Patients with Refractory Large B-cell Lymphoma from ZUMA-1 |
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Mantle Cell, Follicular and Other Indolent B-Cell Lymphomas |
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Abstract #2121 Saturday, December 9, 2023 5:30 – 7:30 PM Halls G-H |
Comparative Effectiveness of Axicabtagene Ciloleucel vs Historical Standard-of-Care in Patients with Relapsed or Refractory Follicular Lymphoma: An Analysis of CIBMTR and SCHOLAR-5 Data |
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Abstract #4868 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Axicabtagene Ciloleucel (Axi-cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL): 4-Year Follow-up from the Phase 2 ZUMA-5 Trial |
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Abstract #4424 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Physician Treatment Preferences in Relapsed/Refractory Follicular Lymphoma: A Discrete Choice Experiment |
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Abstract #5082 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Cost-effectiveness of Axicabtagene Ciloleucel Versus Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma in the US |
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Abstract #4869 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
An Updated Comparison of Clinical Outcomes from 4-year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma |
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Abstract #4865 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
A Retrospective Intra-Patient Analysis from ZUMA-5: Axicabtagene Ciloleucel (Axi-cel) Compared with Prior Standard-of-Care (SOC) Therapy in Patients with Relapsed/Refractory Follicular Lymphoma |
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Abstract #5136 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Matching-Adjusted Indirect Comparison (MAIC) of Brexucabtagene Autoleucel (Brexu-cel) and Pirtobrutinib in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (cBTKi) |
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Abstract #2120 Saturday, December 9, 2023 5:30 – 7:00 PM Halls G-H |
Assessment of Early Intervention Strategies for Management of Cytokine Release Syndrome and Neurologic Events after Brexucabtagene Autoleucel (Brexu-cel) Treatment in Patients with Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) in ZUMA-2 |
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TBD |
A Propensity Score-Matched Analysis on the Outcomes of Brexucabtagene Autoleucel from ZUMA-2 Study and Allogeneic Stem Cell Transplantation from the EBMT Database in Relapsed and Refractory Post-BTKi Mantle Cell Lymphoma*
*In collaboration with EBMT |
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Higher-Risk Myelodysplastic Syndromes |
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Abstract #2434 Saturday, December 9, 2023 5:30 – 7:30 PM Halls G-H |
Evaluation of Disparities in Higher-Risk Myelodysplastic Syndromes (HR- MDS) Patient Treatment Patterns in a Large US Health System |
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Abstract #5101 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
A Patient-Centered Programmatic Approach for Higher-Risk Myelodysplastic Syndromes (HR-MDS) in the US Community Oncology Setting |
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Abstract #5100 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Machine Learning Approach to Understand Real-World Treatment in Patients with Higher-Risk Myelodysplastic Syndromes |
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Abstract #5178 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Patient, Caregiver, and Physician Perspectives on Communication in Diagnosing and Treating Higher-Risk Myelodysplastic Syndromes: A Qualitative Study |
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Multiple Myeloma |
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Abstract #3383 Sunday, December 10, 2023 6:00 – 8:00 PM Halls G-H |
Safety and Tolerability of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Safety Run-in Results from a Phase 2 Study |
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Independently Led and Sponsored** |
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Abstract #4884 Monday, December 11, 2023 6:00 – 8:00 PM Halls G-H |
Cladribine and Cyclophosphamide Lymphodepletion Prior to Axicabtagene Ciloleucel in Relapsed or Refractory Large B-cell Lymphoma |
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Abstract #6126 |
Radiomic Features Prognosticates Treatment Response in CAR T-cell Therapy |
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Real World Data of Axicabtagene Ciloleucel as Second Line Therapy for Patients with Large B-cell Lymphoma: First Results of a LYSA Study from the French DESCAR-T Registry |
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Efficacy and Tolerance of Brexucabtagene Autoleucel in Adults with Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia – A GRAALL Study from the DESCAR-T Registry |
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Publication Only |
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Abstract #6899 |
Statistical Challenges from Trials of Potentially Curative Treatments: Validation of Cure Assumptions When Analyzing ZUMA-7 Follow-up Data of Axi-cel and Standard of Care Therapy |
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For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2023/webprogram/start.html
**Presentations independently led and sponsored feature Kite CAR T-cell therapies, but are not included in Kite accepted abstracts.
About Yescarta
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
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
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
- 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.
- YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
CYTOKINE RELEASE SYNDROME (CRS)
CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non- Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (56/2) 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 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.
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.
Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. 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
Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.
The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.
The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS.
Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.
REMS
Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS
Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.
SERIOUS INFECTIONS
Severe or life-threatening infections occurred. 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 infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.
Febrile neutropenia was observed in 36% of all 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, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and 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 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. 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
Secondary malignancies may develop. Monitor life-long secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion.
Contacts
Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Gilead Media
msmith@gilead.com
Anna Padula, Kite Media
apadula@kitepharma.com