-- 16 Abstracts, Including Three Oral Presentations, Highlight Breadth of Company’s Innovation in Immuno-Oncology for Patients with Blood Cancers --
-- Kite Data Highlight Yescarta® Long-Term Efficacy in Relapsed/Refractory Large B-Cell Lymphoma, its Potential as An Earlier Line of Therapy in DLBCL, as well as Results in Other Cancers, and One-Year Follow-up Results for Tecartus™ in Relapsed Mantle Cell Lymphoma --
-- Magrolimab Demonstrates Continued Response Rates in Updated Results of Phase 1b Study of Acute Myeloid Leukemia Patients, Including Those with TP53 Mutation --
FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that 16 abstracts, including three oral presentations from the companies’ combined immuno-oncology research and development programs, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting, which is being held virtually on December 5-8, 2020, will feature presentations on Yescarta® (axicabtagene ciloleucel), Tecartus™ (brexucabtagene autoleucel, KTE-X19) and other ongoing research from Kite’s chimeric antigen receptor (CAR) T cell therapy development program, as well as magrolimab, Gilead’s first-in-class, investigational anti-CD47 monoclonal antibody.
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“The evidence supporting our innovation in hematologic malignancies continues to grow, providing assurance of the lasting and positive impact our diverse oncology pipeline could achieve over time,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We continue to see broad potential across our oncology portfolio – anchored by Kite in cell therapy and Gilead’s anti-CD47 monoclonal antibody – to transform care for patients with hard-to-treat blood cancers.”
New Long-Term Efficacy Data and the Potential of CAR T Therapy for More Patients
Building on three-year data presented at ASH 2019, overall survival results at four years from the pivotal ZUMA-1 trial of Yescarta in patients with refractory large B-cell lymphoma will be presented (Abstract #1187). Additionally, new data include one-year follow-up results from the ZUMA-2 study evaluating KTE-X19 in relapsed or refractory mantle cell lymphoma (Abstract #1120), as well as several studies evaluating the potential of Yescarta in new indications include an interim analysis of ZUMA-12 in first-line large B-cell lymphoma among patients with high-risk features (Abstract #405) and the ZUMA-5 primary analysis in relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL; Abstract #700).
Data from the ZUMA-5 primary analysis form the basis for the supplemental Biologics License Application (sBLA) for Yescarta currently under review by the U.S. Food & Drug Administration (FDA). Yescarta has previously been granted a Breakthrough Therapy Designation by the FDA for relapsed or refractory FL or MZL after at least two prior therapies and has been granted a Priority Review with a target action date, under the Prescription Drug User Fee Act (PDUFA), of March 5, 2021.
“Our data at ASH build on the established strengths of our CAR T franchise, including practice-changing potential in new cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “As we become the first company to present four-year CAR T data from a pivotal study in large B-cell lymphoma and continue to expand our leadership in cell therapy across different hematologic malignancies “Our data at ASH build on the established strengths of our CAR T franchise, including practice-changing potential in new cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “As we become the first company to present four-year CAR T data from a pivotal study in large B-cell lymphoma and continue to expand our leadership in cell therapy across different hematologic malignancies and into earlier lines of therapy, we remain committed to bringing the benefits of cell therapies to as many patients as possible.”
Harnessing Potential First-in-Class Anti-CD47 Antibody in Difficult-to-Treat Malignancies
Researchers will give an oral presentation of updated results from the Phase 1b study of magrolimab in patients with previously-untreated acute myeloid leukemia (AML) who cannot undergo treatment with intensive chemotherapy, including patients with TP53-mutant AML (Abstract #330). The FDA recently assigned Breakthrough Designation to magrolimab, in combination with azacitidine for the treatment of adult patients with newly-diagnosed MDS including intermediate-, high-, or very high-risk tumor types to expedite the development and regulatory review of this investigational treatment. Magrolimab also received PRIME Designation for treatment of MDS from the European Medicines Agency (EMA).
Dates and times for all accepted abstracts are as follows:
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https://www.gilead.com/news-and-press/press-room/press-releases/2020/11/gilead-and-kite-to-share-latest-scientific-advances-in-hematologic-malignancies-at-ash-2020 |
