Kite Data at EHA 2024 Demonstrate Positive Patient Outcomes and Advances in Delivery of CAR T-cell Therapy
– Analysis Comparing Real-World and Clinical Trial Data Show Yescarta® Has Higher Manufacturing Success Rates and Improved T-Cell Performance, Respectively, in Second-Line vs. Third-Line+ Treatment of Large B-cell Lymphoma –
– Encore Oral Presentation from the Phase 1 Study of Anitocabtagene autoleucel (anito-cel) in Relapsed/Refractory Multiple Myeloma (R/R MM); Trial Design for Phase 3 iMMagine-3 Pivotal Study for R/R MM to be Published as E-Publication –
Four presentations will highlight real-world experience with Yescarta (axicabtagene ciloleucel), including manufacturing experience for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in second-line versus third-line treatment and beyond. The real-world manufacturing analysis investigated potential benefits of administering Yescarta in earlier lines of therapy by assessing manufacturing success rate and product characteristics.
Analyses exploring outpatient administration of Yescarta in R/R LBCL includes preliminary results of the Phase 2 ZUMA-24 study to evaluate the safety and efficacy of Yescarta outpatient administration compared to previous in-hospital clinical trials and real-world evidence. A real-world analysis on the use of Yescarta and Tecartus® (brexucabtagene autoleucel) assess safety trends and hospitalization rates following treatment to further understand the feasibility of CAR T-cell therapy administration in the outpatient setting.
“Whether it’s continuing to evolve our industry-leading manufacturing capabilities or looking at different ways patients can obtain CAR T-cell therapy, such as in the outpatient setting, our goal is to improve patient outcomes and experience with our therapies,” said Ibrahim Elhoussieny, Vice President, Medical Affairs, Kite. “These data will reflect our progress in helping CAR T reach more people with complex and hard-to-treat blood cancers.”
Kite and its multiple myeloma (MM) partner Arcellx will share the clinical trial design for the pivotal Phase 3 iMMagine-3 trial, which will investigate the efficacy and safety of anitocabtagene autoleucel (anito-cel) versus standard of care in patients with R/R MM. In addition, Arcellx will highlight findings from the Phase 1 study of anito-cel in R/R MM in an oral presentation. Anito-cel is an BCMA CAR T investigational that utilizes a novel binder (or CAR) known as the D-Domain. Its small size (8kDa) facilitates high T-cell transduction and expression, resulting in more CAR positive cells and more CARs expressed per T-cell.
Table of Accepted Abstracts (all times CEST):
Abstract Details |
Titles |
Lymphomas |
|
Poster P1425 Fri, June 14, 2024 6:00 – 7:00 PM CEST
|
Real-World Manufacturing Experience of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Large B-Cell Lymphoma Treated in Second Line versus Third Line of Therapy and Beyond
Jason R. Westin, Dalia Rangel, José G. Ramírez, David Myers, Laura Alquist, Clare Spooner, Harry W. Smith, Rhine R. Shen, Simone Filosto, and Frederick L. |
Poster P1159 Fri, June 14, 2024 6:00 – 7:00 PM CEST
|
ZUMA-24 Preliminary Analysis: A Phase 2 Study of Axicabtagene Ciloleucel in the Outpatient Setting with Prophylactic Corticosteroids in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Lori A. Leslie, John H. Baird, Ian W. Flinn, Michael Tees, Daanish Hoda, Abhinav Deol, Monica Mead, Brian McClune, Indumathy Vanadarajan, James Essell, Suzanne Fanning, Gary Simmons, William Clark, Aaron P. Rapaport, Tulio E. Rodriguez, Joshua N. Winters, Madison Davis, Harry M. Miao, Yan Zheng, Jenny J. Kim, and Olalekan O. Oluwole. |
ePoster P2092 Fri, June 14, 2024 9:00 AM CEST
|
Complete Response at 6 Months as Associated with Overall Survival After 1L Chemoimmunotherapy for High-Risk Diffuse Large B-Cell Lymphoma: A Pooled Clinical Trial Analysis
Ran Reshef, Zhen-Huan Hu, Sarit Assouline, Corinne Haioun, Bertram Glass, Armin Ghobadi, Rahul Jain, Weixi Chen, Yiling Yang, Kelly Speth, Shilpa A. Shahani, Myrna Nahas, Elizabeth Shima Rich, Clare Spooner, Qinghua Song, Fang Sun, and Michael Dickinson. |
Poster P1199 Fri, June 14, 2024 6:00 – 7:00 PM CEST
|
Real-World Outcomes of Axicabtagene Ciloleucel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma in
Christopher Lemieux, John Kuruvilla, Mona Shafey, Kelly Davidson, Kristjan Paulson, Brent Logan, Matthew Bye, Sue Li, Lieven Billen, Francis Nissen, Hai-Lin Wang, Jenny J. Kim, Harry Smith, Grace Lee, Zhen-Huan Hu, Marcelo C. Pasquini, and Kevin Hay. |
Oral S334 Sat, June 15, 2024 4:30 – 5:45 PM CEST
|
The Cost-Effectiveness of Axicabtagene Ciloleucel versus Standard of Care as Second-Line Therapy in Patients with Large B-Cell Lymphoma in
Oskar Eklund, Viktor Hedlof Kanje, Yael A. Rodriguez-Guadarrama, Rob Blissett, Nathaniel J. Smith, Frank van Hees, Brett Doble, and Sachin Vadgama. |
Poster P1217 Fri, June 14, 2024 6:00 – 7:00 PM CEST
|
Cost-effectiveness and Budget Impact Analyses of Axicabtagene Ciloleucel as Second-Line Therapy in Patients with Large B-Cell Lymphoma in
Francesca Lim, Tza-Kai Diong, Graeme Ball, Esther Chan, Mahendra Rai, Jatin Pruthi, Neha Deshpande and William Hwang. |
ePoster P2088 Fri, June 14, 2024 9:00 AM CEST
|
Real-World Safety Outcomes of Axicabtagene Ciloleucel in Patients with Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in
Robin Sanderson, Javier Munoz, Francis Ayuk, Francis Nissen, Fang Sun, Eve Limbrick-Oldfield, David Wennersbusch, Grace Lee and Caron A. Jacobson. |
Poster P1666 Fri, June 14, 2024 6:00 – 7:00 PM CEST
|
Treatment Preferences and Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma
John G. Gribben, Emmanuel Bachy, Markqayne Ray, Kathryn Krupsky, Kathleen Beusterien, Lewis Kopenhafer, Flor Mendez, Sara Beygi, Timothy Best, Graeme Ball, Kacper Perkowski, Oliver Will, Anik Patel and Paola Ghione. |
Poster P1191 Fri, June 14, 2024 6:00 – 7:00 PM CEST
* In collaboration with Mayo Clinic |
Updated Trends in Real-World Outpatient (OP) Administration of Axicabtagene Ciloleucel (Axi-Cel) and Brexucabtagene Autoleucel (Brexu-Cel) in Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL)*
Radhika Bansal, Hil Hsu, Jonas Paludo, Brad Du, Andre De Menezes Silva Corraes, Patrick Johnston, Arushi Khurana, Yucai Wang, Christine Fu, Jenny J. Kim, Qinghua Song, James Wu, Fang Sun and Yi Lin. |
Multiple Myeloma |
|
E-publication only PB2724
To be published in the Online Abstract Book, a supplement of HemaSphere (EHA’s official journal)
*In collaboration with Kite partner Arcellx |
iMMagine-3: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel (Anito-Cel) with Standard of Care in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Tom Martin, Noopur S. Raje, Jesús |
Oral S207
*In collaboration with Kite partner Arcellx |
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-Year Follow-up in All Patients*
Matthew Frigault, Jacalyn Rosenblatt, Binod Dhakal, Noopur Raje, Daniella Cook, Mahmoud Gaballa, Estelle Emmanuel-Alejandro, Danielle Nissen, Kamalika Bannerjee, Anand Rotte, Christopher Heery, David Avigan, Andrzej Jakubowiak and Michael Bishop. |
Acute Lymphoblastic Leukemia |
|
E-publication only PB3430
To be published in the Online Abstract Book, a supplement of HemaSphere (EHA’s official journal) |
Sustained Cost-Effectiveness of Brexucabtagene Autoleucel for the Treatment of Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in Patients Aged 26 Years or Older in
Monia Marchetti, Cristina Dondoni, Tomas Spousta, Frank van Hees, Nate Smith and Brett Doble.
|
For more information, including a complete list of abstract titles at the meeting, please visit: https://congress-apps.ehaweb.org/eha2024/en-GB/pag/
About anitocabtagene autoleucel (anito-cel)
Anito-cel is a BCMA CAR T that utilizes a novel binder (or CAR) known as the D-Domain. Its small size (8kDa) facilitates high T-cell transduction and expression, resulting in more CAR positive cells and more CARs expressed per T-cell.
Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the
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 (see Table 1), 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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in
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 and anito-cel; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for 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 March 31, 2024, as filed with the
Kite, the Kite logo, Yescarta, Tecartus, Gilead and the Gilead 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.
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Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Gilead Media
Public_Affairs@gilead.com
Source: Gilead Sciences, Inc.