Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World
Kite, a Gilead company, will present 18 studies at ASH 2024, showcasing their CAR T-cell therapy portfolio. Key highlights include positive survival outcomes from both clinical trials and real-world data. The Phase 1 study of anito-cel showed 30.2-month median progression-free survival, while the Phase 2 iMMagine-1 study demonstrated 95% objective response rate. Yescarta® continues to show superior survival rates in the largest real-world analysis for second-line therapy in large B-cell lymphoma. Long-term survival data for both Yescarta® and Tecartus® will be presented from multiple ZUMA studies across various blood cancers.
Kite, una società di Gilead, presenterà 18 studi all'ASH 2024, mettendo in evidenza il loro portafoglio di terapie CAR T-cell. Tra i punti salienti ci sono risultati di sopravvivenza positivi provenienti sia da trial clinici che da dati del mondo reale. Lo studio di Fase 1 di anito-cel ha mostrato una sopravvivenza libera da progressione mediana di 30,2 mesi, mentre lo studio di Fase 2 iMMagine-1 ha dimostrato un tasso di risposta obiettivo del 95%. Yescarta® continua a mostrare tassi di sopravvivenza superiori nell'analisi più ampia del mondo reale per la terapia di seconda linea nel linfoma a grandi cellule B. I dati di sopravvivenza a lungo termine sia per Yescarta® che per Tecartus® saranno presentati da diversi studi ZUMA su vari tipi di cancro del sangue.
Kite, una compañía de Gilead, presentará 18 estudios en ASH 2024, mostrando su cartera de terapias con células T CAR. Los puntos destacados incluyen resultados positivos de supervivencia de ensayos clínicos y datos del mundo real. El estudio de Fase 1 de anito-cel mostró una supervivencia libre de progresión mediana de 30,2 meses, mientras que el estudio de Fase 2 iMMagine-1 demostró una tasa de respuesta objetiva del 95%. Yescarta® sigue mostrando tasas de supervivencia superiores en el análisis más grande del mundo real para terapia de segunda línea en linfoma de células B grandes. Se presentarán datos de supervivencia a largo plazo tanto para Yescarta® como para Tecartus® de múltiples estudios ZUMA en varios cánceres de sangre.
Kite는 Gilead 산하의 회사로, ASH 2024에서 18개의 연구를 발표하며 그들의 CAR T세포 치료 포트폴리오를 소개할 예정입니다. 주요 하이라이트로는 임상 시험 및 실제 데이터에서의 긍정적인 생존 결과가 포함됩니다. anito-cel의 1상 연구는 30.2개월의 중앙 무진행 생존 기간을 보여줬고, 2상 iMMagine-1 연구에서는 95%의 객관적 반응률을 입증했습니다. Yescarta®는 대형 B세포 림프종에 대한 2차 치료의 가장 큰 실제 분석에서 우수한 생존율을 계속 보여주고 있습니다. 여러 혈액암에 걸친 다양한 ZUMA 연구에서 Yescarta®와 Tecartus®에 대한 장기 생존 데이터가 발표될 것입니다.
Kite, une entreprise de Gilead, présentera 18 études lors de l'ASH 2024, mettant en avant son portefeuille de thérapies par cellules T CAR. Parmi les points forts, on trouve des résultats de survie positifs issus d'essais cliniques et de données du monde réel. L'étude de phase 1 de anito-cel a montré une survie médiane sans progression de 30,2 mois, tandis que l'étude de phase 2 iMMagine-1 a démontré un taux de réponse objectif de 95%. Yescarta® continue de montrer des taux de survie supérieurs dans la plus grande analyse du monde réel pour la thérapie en seconde ligne dans le lymphome à grandes cellules B. Des données de survie à long terme pour Yescarta® et Tecartus® seront présentées lors de plusieurs études ZUMA sur divers cancers du sang.
Kite, ein Unternehmen von Gilead, wird auf der ASH 2024 18 Studien präsentieren und dabei ihr Portfolio an CAR-T-Zelltherapien vorstellen. Zu den wichtigsten Highlights gehören positive Überlebensraten aus klinischen Studien und realen Daten. Die Phase-1-Studie von anito-cel wies eine mediane progressionsfreie Überlebenszeit von 30,2 Monaten auf, während die Phase-2-Studie iMMagine-1 eine objektive Ansprechrate von 95% zeigte. Yescarta® zeigt weiterhin überlegene Überlebensraten in der größten Analyse aus der realen Welt für die Zweitlinientherapie bei großzelligem B-Zell-Lymphom. Langzeitüberlebensdaten sowohl für Yescarta® als auch für Tecartus® werden aus mehreren ZUMA-Studien zu verschiedenen Blutkrebsarten präsentiert.
- Phase 1 anito-cel study achieved 30.2-month median progression-free survival
- iMMagine-1 Phase 2 study showed 95% objective response rate and 62% complete response rate
- No delayed neurotoxicities observed in anito-cel studies
- Yescarta demonstrates superior overall survival versus standard therapy
- Five-year follow-up data available for multiple products showing durable responses
- None.
Insights
The clinical data presented at ASH 2024 demonstrates significant advancements in Kite's CAR T-cell therapy portfolio. The 30.2-month median progression-free survival in the Phase 1 anito-cel study and 95% objective response rate in the Phase 2 iMMagine-1 trial represent impressive outcomes for multiple myeloma patients. The 5-year follow-up data from ZUMA-5 and sustained efficacy in real-world studies of Yescarta validate the long-term benefits of CAR T therapy.
The comprehensive safety profile, particularly the absence of delayed neurotoxicities with anito-cel, addresses a key concern in CAR T therapy. Manufacturing improvements for Yescarta suggest enhanced accessibility and predictable treatment delivery. These developments strengthen Gilead's position in the
This robust clinical data portfolio strengthens Kite's market position and could accelerate revenue growth. The positive survival outcomes and manufacturing improvements address two critical commercial barriers: efficacy durability and production scalability. The anito-cel data is particularly significant as it could help Gilead capture market share in the lucrative multiple myeloma space, currently dominated by competitors.
The real-world evidence supporting Yescarta's use in second-line therapy could drive broader adoption and reimbursement coverage. With 18 presentations including six oral presentations, this comprehensive data set should support continued market expansion and potentially higher reimbursement rates, positively impacting Gilead's oncology revenue stream.
– Durability of Response and Continued Manageable Safety Profile for the Phase 1 and iMMagine-1 Studies with Anito-cel in Patients with Relapsed/Refractory Multiple Myeloma to be Presented by Partner Arcellx; Follows Progress with First Patient Dosed in Phase 3 iMMagine-3 Study –
– Survival Rate for Yescarta® Supported by Largest Real-World Analysis of CAR T for Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma –
– Durability of Response and Long-Term Survival with Yescarta® and Tecartus® in Multiple Blood Cancers Observed in ZUMA-5, ZUMA-2, and ZUMA-3 Studies –
“Our data underscore our commitment to helping people with blood cancers live longer and demonstrate the benefit of CAR T-cell therapy as a mainstay of blood cancer treatment,” said Dominique Tonelli, M.D., VP, Global Head of Medical Affairs, Kite. “Notably for this year, along with our partner Arcellx, we are excited to share clinically meaningful data from the Phase 1 study and the iMMagine-1 Phase 2 registrational study of anito-cel for the treatment of relapsed/refractory multiple myeloma.”
Anito-cel Data from Partner, Arcellx
Key presentations for anitocabtagene autoleucel (anito-cel) include data from the Phase 1 study that demonstrate a 30.2-month median progression-free survival (PFS) with a median follow-up of 38.1 months and the median overall survival not yet reached; and preliminary results from 58 patients in the Phase 2 iMMagine-1 study that demonstrate a
Both the Phase 1 and Phase 2 iMMagine-1 studies highlight durable responses in patients with relapsed or refractory (R/R) multiple myeloma (MM) and show no delayed neurotoxicities have been observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain Barre syndrome.
Positive Survival Outcomes with Yescarta® and Tecartus®
Key presentations for Yescarta® (axicabtagene ciloleucel) include a five-year follow-up analysis from ZUMA-5 evaluating response rate and long-term survival in patients with R/R indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma and marginal zone lymphoma. Additionally, Yescarta is the only treatment to have demonstrated superior overall survival versus standard therapy for patients with early R/R large B-cell lymphoma (LBCL), and this continues to be seen in the largest real-world analysis of patients with R/R LBCL who received second-line Yescarta. Additional research will focus on improvements in Yescarta manufacturing for patients with R/R LBCL.
Key presentations for Tecartus® (brexucabtagene autoleucel) include five-year outcomes from ZUMA-2 cohorts 1 and 2 and a primary analysis of ZUMA-2 cohort 3, both highlighting durable responses in adult patients with R/R mantle cell lymphoma (MCL) and showing that Tecartus continues to deliver unprecedented efficacy in R/R MCL three years after its approval. Also to be presented are real-world outcomes in adults with R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) treated with Tecartus, highlighting the CAR T-cell therapy’s high effectiveness in a broader R/R B-ALL patient population.
Advancements in Kite’s pipeline will also be highlighted, including data presented on Kite’s next generation CAR T-cell therapy KITE-753, an autologous anti-CD19/CD20 CAR T-cell therapy for the treatment of B-cell malignancies.
Kite is also collaborating with independent investigators and respected institutions including The Lymphoma Study Association, Sarah Cannon Transplant and Cellular Therapy Network, and Dana-Farber Cancer Institute to share additional insights on Kite’s CAR T-cell therapies.
Dates and times* for accepted abstracts and presentations of note are as follows:
*Times listed are in PT
Oral Presentations |
|
Abstract Details |
Titles |
Axicabtagene ciloleucel |
|
Abstract #526 Sunday, December 8, 2024 10:15 AM Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26 |
Real-World Early Outcomes of Second-Line Axicabtagene Ciloleucel (Axi-Cel) Therapy in Patients (Pts) With Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) |
Abstract #527 Sunday, December 8, 2024 10:30 AM Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26 |
Real-world Trends of Cytokine Release Syndrome and Neurologic Events, and Pattern of Their Management among Patients Receiving Axicabtagene Ciloleucel for Relapsed or Refractory (r/r) Large B-cell Lymphoma (LBCL) in the US: a CIBMTR Report |
Abstract #609 Sunday, December 8, 2024 12:30 PM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 2-4 |
Predictors of Early Safety Outcomes with Axicabtagene Ciloleucel (axi-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) |
Abstract #864 Monday, December 9, 2024 4:00 PM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13
|
5-Year Follow-Up Analysis From ZUMA-5: a Phase 2 Trial of Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma |
Brexucabtagene autoleucel |
|
Abstract #748 Monday, December 9, 2024 11:15 AM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 8-9 |
Primary Analysis of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Were Naive to Bruton Tyrosine Kinase Inhibitors (BTKi)
|
Anitocabtagene autoleucel |
|
Abstract #1031 Monday, December 9, 2024 5:30 PM Marriott Marquis San Diego Marina, Pacific Ballroom 24-26 |
Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial
*Led by Arcellx |
Poster Presentations |
|
Axicabtagene ciloleucel |
|
Abstract #2367 Saturday, December 7, 2024 5:30 PM - 7:30 PM
|
Treatment Patterns and Predictors of Survival after First Line Therapy in Large B-Cell Lymphoma in a Real-World US Cohort |
Abstract #3347 Sunday, December 8, 2024 6:00 PM - 8:00 PM
|
Improvements in Axicabtagene Ciloleucel Manufacturing Result in High Delivery Success and More Predictable Turnaround Time for Patients With Relapsed/Refractory Large B-Cell Lymphoma |
Abstract #4368 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Impact of Inflammation, Tumor and Product Attributes on Clinical Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Axicabtagene Ciloleucel |
Abstract #5037 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Estimating the Impact on Survival of Not Receiving CAR T Therapy Despite Being Eligible in Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Patients in |
Brexucabtagene autoleucel |
|
Abstract #4388 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Five-Year Outcomes of Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated With Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 Cohorts 1 and 2 |
Abstract #5092 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Real-World (RW) Outcomes for Brexucabtagene Autoleucel (Brexu-Cel) Treatment in Patients (Pts) With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) by High-Risk Features and Prior Treatments: Updated Evidence From the CIBMTR® Registry |
Abstract #4193 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Impact of disease burden, CAR-T expansion, and mononuclear cell recovery on overall response and duration of response in ZUMA-3 pivotal study |
Anitocabtagene autoleucel |
|
Abstract #4825 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM): Efficacy and Safety With 34-Month Median Follow-up
*Led by Arcellx |
Kite next generation CAR T-cell therapies |
|
Abstract #3481 Sunday, December 8, 2024 6:00 PM - 8:00 PM
|
KITE-753: An Autologous Rapid Manufactured Anti-CD19/CD20 CAR-T Product for the Treatment of B-cell Malignancies |
Investigator-Sponsored / Collaboration** |
|
Abstract #4505 Sunday, December 8, 2024 6:00 PM - 8:00 PM
|
Health-related quality of life after Axi-cel as a second-line therapy in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation: results of the ALYCANTE phase II trial
*Led by The Lymphoma Study Association |
Abstract #4721 Monday, December 9, 2024 6:00 PM - 8:00 PM
|
Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis
*Investigator led |
Abstract #3734 Sunday, December 8, 2024 6:00 PM - 8:00 PM
|
The Patient Journey and Treatment Outcomes Comparing Inpatient Versus Outpatient Axicabtagene Ciloleucel in Non-Hodgkin’s Lymphoma (NHL) - a Large, Multicenter Study
*In collaboration with Sarah Cannon Transplant and Cellular Therapy Network |
Abstract #3124 Sunday, December 8, 2024 6:00 PM - 8:00 PM
|
CAR T-cells for relapsed/refractory B-cell lymphoma in people living with HIV (PLWH): a LYSA study from the DESCAR-T registry
*Led by The Lymphoma Study Association |
Abstract #2031 Saturday, December 7, 2024 6:00 PM - 8:00 PM
|
Early MRD detection after CAR-T Associated with Poor Outcome in LBCL
*In collaboration with Dana-Farber Cancer Institute |
Abstract #239 Saturday, December 7, 2024 3:00 PM Session: 623 (2:00 - 3:30 PM) Marriot Grand Ballroom 11-13 |
Outcome of patients with Mantle cell lymphoma after failure of anti-CD19 CAR T-cell therapy: a DESCAR-T Study By Lysa Group *Led by The Lymphoma Study Association |
Abstract # Date TBD Time TBD Room TBD |
A Real-World Weighted Comparison of Tisagenlecleucel and Axicabtagene Ciloleucel CAR T Cells in Relapsed or Refractory Diffuse Large B Cell Lymphoma Aged 75 Years and Older: A Lysa Study from the Descar-T Registry
*Led by The Lymphoma Study Association |
Publication Only |
|
Abstract #7775
|
Real-World Interim PET/CT Scan Use During Frontline (1L) Therapy and Subsequent Treatment Characteristics in Patients with Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
Abstract #7607 |
Short-term Costs Associated With Outpatient Use of Axicabtagene Ciloleucel in Second-line Relapsed/Refractory Large B-cell Lymphoma Based on ZUMA-24 Clinical Trial |
Abstract #7592
|
A |
Abstract #6962
|
Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database |
Abstract #7159 |
In Vitro and In Vivo Characterization of Axicabtagene Ciloleucel Identifies Features Associated with Treatment Resistance in Patients, Including a Dysfunctional CD8+ T Cell State Characterized by Overexpression of GATA3 Transcript |
For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2024/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
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).
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. 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.
- 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 following treatment with YESCARTA. CRS occurred in
CRS occurred in
Key manifestations of CRS (≥
The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in
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 (
Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 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
Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in
The most common neurologic toxicities (≥
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
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
Febrile neutropenia was observed in
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
HYPOGAMMAGLOBULINEMIA
B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in
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.
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. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
ADVERSE REACTIONS
The most common non-laboratory adverse reactions (incidence ≥
The most common adverse reactions (incidence ≥
The most common non-laboratory adverse reactions (incidence ≥
About Tecartus
Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.
Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
-
Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with 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
- Tecartus 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), including life-threatening reactions, occurred following treatment with Tecartus. CRS occurred in
Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four 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 Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in
The most common neurologic events (>
Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.
REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:
- Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS.
- Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.
Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in
Febrile neutropenia was observed in
In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) 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, 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 Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in
Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in
The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.
Secondary Malignancies may develop. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. 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 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 Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.
Adverse Reactions: The most common non-laboratory adverse reactions (≥
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in
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
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed or refractory multiple myeloma, RRMM. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a Phase 3 randomized controlled study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in
About Anitocabtagene autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-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. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the
About iMMagine-3 Global Phase 3 Randomized Controlled Clinical Study
iMMagine-3 is a global Phase 3, randomized controlled study designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.
iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1.
The primary endpoint is progression free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety.
The iMMagine-3 study initiated in the second half of 2024 at approximately 130 study sites across
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, Yescarta anito-cel and KITE-753 (such as iMMagine-1, ZUMA-2, ZUMA-3 and ZUMA-5); 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, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the
Tecartus, Yescarta, Gilead, the Gilead logo, Kite, the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X (@KitePharma) and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241105435302/en/
Meaghan Smith, Gilead Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
What are the key efficacy results from the Phase 2 iMMagine-1 trial for GILD's anito-cel?
What is the progression-free survival data for GILD's anito-cel in the Phase 1 study?
How many presentations will Kite (GILD) present at ASH 2024?