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Gilead, Co.'s Kite Pharma Highlight Acceptance Of 9 Abstracts During ASCO 2020

Gilead Sciences, Inc. (NASDAQ:GILD) and Kite, a Gilead Company, today announced the acceptance of nine abstracts, including three oral presentations across its immuno-oncology research and development program, during the

Benzinga · 05/13/2020 21:01

Gilead Sciences, Inc. (NASDAQ:GILD) and Kite, a Gilead Company, today announced the acceptance of nine abstracts, including three oral presentations across its immuno-oncology research and development program, 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200513005577/en/

“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 has the potential to bring significant benefit to patients with certain hematologic 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 Hematologic Malignancies

Updated results from a Phase 1b study of magrolimab in patients with myelodysplactic 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). Magrolimab has the potential to be a first-in-class anti-CD47 antibody based on its mechanism of action and emerging clinical data.

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 Yescarta® (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). Yescarta has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for relapsed or refractory follicular lymphoma or marginal zone lymphoma (two subtypes of iNHL) after at least two prior systemic therapies.

“At Kite, we are committed to advancing science to bring potentially curative therapies to patients with hematologic 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.”

Early Progress with Cell Therapy in Solid Tumors

Data focused on T cell receptor (TCR) technology, a promising approach to solid tumor-directed cell therapy under investigation, also will be featured in an oral presentation. Results from a Phase 1 clinical trial conducted by the National Cancer Institute (NCI), as part of a Cooperative Research and Development Agreement (CRADA) between the Experimental Transplantation and Immunology Branch (ETIB) of the NCI and Kite, describe the safety and clinical activity of E7 TCR T cells in patients with highly refractory metastatic human papillomavirus (HPV)-16 cancers, such as vulvar, anal, head and neck, and cervical cancer (Abstract #101). Additionally, Kite has an IND for its own candidate, KITE-439, based on the NCI E7 TCR, and is currently conducting a Phase 1 study of investigational KITE-439 in patients with relapsed or refractory HPV-16-positive cancers (Abstract #TPS3149).

Accepted abstracts are as follows:

Area of Focus and
Presentation Number

Abstract Title

Presentations

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)

Solid Tumors
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

Trials-In-Progress

Solid Tumors
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

Online Publication

Lymphoma
(Online only)

Health-Related Quality of Life Burden in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Non-Hodgkin’s Lymphoma

MDS and AML
(Online only)

Pharmacokinetic-Pharamcodynamic Analysis and Receptor Occupancy Data to Support Every Other Week Maintenance Dosing of Magrolimab in Combination with Azacitidine in MDS/AML Patients

*Presentation will be made available on-demand beginning Friday, May 29 at 8:00 am ET.

For more information, including a complete list of abstract titles at the meeting, please visit: https://meetinglibrary.asco.org/.

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of 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, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of cytokine release syndrome (CRS) and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

The use of Yescarta 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.