— Nine Abstracts, Including Three Oral Presentations, Highlight Commitment in Haematologic Malignancies and Early Progress in Solid Tumours —
— Interim Analysis from Phase 2 Study Investigating Yescarta® (axicabtagene ciloleucel) in Indolent Non-Hodgkin Lymphoma and New Phase 1b Data for Investigational Magrolimab Among Oral Presentations —
Foster City, Calif. and Santa Monica, Calif., 07:00AM BST, 08:00AM CET, May 14, 2020 – Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced the presentation of nine abstracts, including three oral presentations, across its immuno-oncology research and development programme, during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting being held from May 29-31, 2020. Data at ASCO include abstracts highlighting Kite’s leading cell therapy portfolio and magrolimab, an investigational anti-CD47 monoclonal antibody developed by Forty Seven, Inc., which was recently acquired by Gilead.
“Gilead has a deep commitment to innovation in oncology. Our colleagues at Kite are driving advances in cell therapy, and our growing immuno-oncology portfolio at Gilead now includes magrolimab, which is under investigation for patients with certain haematologic malignancies,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The presentations at ASCO underscore the strength of our scientific approach in immuno-oncology, and we look forward to sharing this latest research.”
Continuing Scientific Advances in Haematologic Malignancies
Updated results from a Phase 1b study of magrolimab in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), including highly under-served AML patients with P53 mutations, will be the focus of an oral presentation (Abstract #7507).
Additionally, new data building on Kite’s leadership in chimeric antigen receptor (CAR) T cell therapy include an interim analysis from the Phase 2 ZUMA-5 study evaluating an investigational use of axicabtagene ciloleucel in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). These data will also be featured in an oral presentation (Abstract #8008).
“At Kite, we are committed to advancing science to bring highly innovative therapies to patients with haematologic malignancies and other cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “Our data at ASCO represent important progress as we work toward this goal.”
Area of Focus and Presentation Number
MDS and AML
Abstract #7507 (Oral)*
Tolerability and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine in MDS and AML Patients: Phase 1b Results
Non-Hodgkin Lymphoma Abstract #8008 (Oral)*
Interim Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (R/R iNHL)
Abstract #101 (Oral)*
(NCI study: NCT02858310)
Safety and Clinical Activity of Gene-engineered T-Cell Therapy Targeting HPV-16 E7 for Epithelial Cancers
Large B-cell Lymphoma Abstract #8012 (Poster 345)*
Retreatment of Patients with Refractory Large B-cell Lymphoma with Axicabtagene Ciloleucel (Axi-Cel) in ZUMA-1
Mantle Cell Lymphoma
Abstract #3023 (Poster 87)*
Product Characteristics and Pharmacological Profile of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL) in the Phase 2 Registrational ZUMA-2 Trial
Large B-cell Lymphoma Abstract #3022 (Poster 86)*
Tumor Microenvironment Associated With Increased Pretreatment Density of Activated PD-1+ LAG-3+/− TIM-3− CD8+ T Cells Facilitates Clinical Response to Axicabtagene Ciloleucel (Axi-Cel) in Patients with Large B-cell Lymphoma
Abstract #TPS3149 (Poster 213)*
KITE-439: A Phase 1 Study of HPV16 E7 T Cell Receptor-Engineered T Cells in Patients with Relapsed/Refractory HPV16-Positive Cancers
Health-Related Quality of Life Burden in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Non-Hodgkin’s Lymphoma
MDS and AML
Pharmacokinetic-Pharamcodynamic Analysis and Receptor Occupancy Data to Support Every Other Week Maintenance Dosing of Magrolimab in Combination with Azacitidine in MDS/AML Patients
For more information, including a complete list of abstract titles at the meeting, please visit: https://meetinglibrary.asco.org/.
On 23 August 2018, axicabtagene ciloleucel received European Marketing Authorisation for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy. Axicabtagene ciloleucel was licensed by the U.S. Food and Drug Administration on October 18, 2017.
The use of axicabtagene ciloleucel in relapsed or refractory iNHL is investigational and not approved globally. It’s efficacy and safety have not been established in this indication.
Magrolimab, KTE-X19 and KITE-439 are investigational and not approved anywhere globally. Their efficacy and safety have not been established. More information about clinical trials with magrolimab, KTE-X19 and KITE-439 is available at www.clinicaltrials.gov.
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
 European Medicines Agency. Yescarta (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-productinformation_en.pdf Accessed May 2020.
 U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Available at: https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm 581222.htm Accessed May 2020.