On November 4, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 11-14) will showcase continued leadership across both approved and investigational CAR T-cell therapies and medicines (Press release, Gilead Sciences, NOV 4, 2021, View Source [SID1234594534]). Gilead and Kite will present more than 20 abstracts, including a plenary presentation and six oral presentations, across several hematological malignancies including large B-cell lymphoma (LBCL), non-Hodgkin lymphoma (NHL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
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"This ASH (Free ASH Whitepaper) meeting illustrates the growing maturity of data regarding the potential of our CAR T-cell therapies to be used earlier in treatment along with long-term follow-up data," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "As we continue to build on the established strengths of Kite’s CAR T franchise, our goal is to provide differentiated treatment options to patients that have the potential to change standard of care and deliver the hope of survival to more people with blood cancers."
In cell therapy, Kite will present the first efficacy and safety results from the landmark ZUMA-7 study in LBCL as part of ASH (Free ASH Whitepaper)’s plenary sessions. Additional research from Kite, focused on long-term follow-up data and quality of life improvements for people with certain blood cancers treated with the company’s CAR T-cell therapies, will also be presented.
"The Gilead and Kite data presentations at ASH (Free ASH Whitepaper) reinforce our diverse oncology pipeline focused on helping bring more life to people with cancer, especially in areas where few options exist," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We see broad potential across our oncology portfolio as we advance transformative science for people with hard-to-treat blood cancers."
Researchers will also share early-stage research on magrolimab, an investigational CD47 inhibitor, both in an oral session and in an ASH (Free ASH Whitepaper)-EHA Joint Symposium. During the symposium, Targeting Macrophages and the Innate Immune System to Treat Hematologic Malignancies, potential new approaches to cancer therapies will be showcased. Early data suggest these approaches, including activating the innate immune system, could become foundational to the next generation of oncology treatment.
Dates and times for accepted abstracts and presentations of note are as follows:
Abstract Details
Titles
Plenary Session
Large B-cell Lymphoma
Abstract #2
Sunday, Dec 12
(2:00 pm ET / 11:00 am PT)
Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Oral Presentations
Large B-cell Lymphoma
Abstract #430
Sunday, Dec 12
(10:15 am ET / 7:15 am PT)
Patient-Reported Outcomes in a Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma (ZUMA-7)
Large B-cell Lymphoma
Abstract #530
Sunday, Dec 12
(4:45 pm ET / 1:45pm PT)
Real-World Outcomes of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma: Impact of Age and Specific Organ Dysfunction
Large B-cell Lymphoma
Abstract #739
Monday, Dec 13
(2:45 pm ET / 11:45 am PT)
Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel as First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma
Large B-cell Lymphoma
Abstract #901
Monday, Dec 13
(6:15 pm ET / 3:15 pm PT)
TNFR2 as a Target to Improve CD19-Directed CAR T-Cell Fitness and Antitumor Activity in Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Abstract #93
Saturday, Dec 11
(10:00 am ET / 7:00 am PT)
Long-Term Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Investigator-Sponsored Research (ISR) Oral Presentation
Acute Myeloid Leukemia
Abstract #371
Sunday, Dec 12
(9:30 am ET / 6:30 am PT)
Phase I/II Study of Azacitidine with Venetoclax and Magrolimab in Patients with Newly Diagnosed Older/Unfit or High-Risk Acute Myeloid Leukemia (AML) and Relapsed/Refractory AML
Poster Presentations
Large B-cell Lymphoma
Abstract #1764
Saturday, Dec 11
(5:30 pm ET / 2:30 pm PT)
Long-Term (4- and 5-Year) Overall Survival in ZUMA-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL)
Large B-cell Lymphoma
Abstract #1424
Saturday, Dec 11
(5:30 pm ET / 2:30 pm PT)
Chimeric Antigen Receptor T-Cell Therapy Treatment Patterns: A Retrospective Cohort Analysis of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients in the US
Follicular Lymphoma
Abstract #1350
Saturday, Dec 11
(5:30 pm ET / 2:30 pm PT)
Safety and Effectiveness of Idelalisib in Patients with Double Refractory Follicular Lymphoma: A Pan European Cohort of 242 Patients
Large B-cell Lymphoma Abstract #2832
Sunday, Dec 12
(6:00 pm ET / 3:00 pm PT)
Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma: One-Year Follow-Up of ZUMA-1 Cohort 6
Large B-cell Lymphoma
Abstract #151459
Sunday, Dec 12
(6:00 pm ET / 3:00 pm PT)
Profiling the Peripheral Blood Immune Cell Repertoire in Large B-Cell Lymphoma Patients Treated with CD19 CAR-T
Large B-cell Lymphoma
Abstract #2814
Sunday, Dec 12
(6:00 pm ET / 3:00 pm PT)
A Phase II Trial of Anakinra for the Prevention of CAR T-Cell Mediated Neurotoxicity
Large B-cell Lymphoma Abstract #2833
Sunday, Dec 12
(6:00 pm ET / 3:00 pm PT)
Prediction of Early Onset Cytokine Release Syndrome and Neurologic Events After Axicabtagene Ciloleucel in Large B-Cell Lymphoma Based on Machine Learning Algorithms
Follicular Lymphoma
Abstract #3543
Monday, Dec 13
(6:00 pm ET / 3:00 pm PT)
A Comparison of Clinical Outcomes from Updated ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma
Mantle Cell Lymphoma
Abstract #3844
Monday, Dec 13
(6:00 pm ET / 3:00 pm PT)
The Comparison of KTE-X19 to Current Standards of Care: A Pre-Specified Synthetic Control Study Utilizing Individual Patient Level Data from Historic Clinical Trials (SCHOLAR-3)
Mantle Cell Lymphoma
Abstract #3849
Monday, Dec 13
(6:00 pm ET / 3:00 pm PT)
Effects of Prior Exposure to Tec Kinase Inhibitors on KTE-X19 Products
Trials-In-Progress (TiP)
Multiple Myeloma
Abstract #2757
Sunday, Dec 12
(6:00 pm ET / 3:00 pm PT)
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple Myeloma
Acute Myeloid Leukemia
Abstract #3424
Monday, Dec 13
(6:00 pm ET / 3:00 pm PT)
A Phase 2, Open-Label, Multiarm, Multicenter Study to Evaluate Magrolimab Combined with Antileukemia Therapies for First-Line, Relapsed/Refractory, or Maintenance Treatment of Acute Myeloid Leukemia
Acute Myeloid Leukemia
Abstract# 3426
Monday Dec 13
(6:00 pm ET / 3:00 pm PT)
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine in Previously Untreated Patients with TP53-Mutant Acute Myeloid Leukemia
Myelodysplastic Syndrome
Abstract #7055
Monday, Dec 13
(6:00 pm ET / 3:00 pm PT)
Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher-Risk (HR) Myelodysplastic Syndrome (MDS): The Phase 3 Randomized, ENHANCE Study
For more information, including a complete list of abstract titles at the meeting, please visit: View Source