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Press Releases

Gilead and Kite Oncology Demonstrate Broad Leadership in Cell Therapy and Expanding Blood Cancer Pipeline

Kite’s Landmark CAR T-Cell Therapy Study ZUMA-7 in Relapsed/Refractory Large B-Cell Lymphoma to be Featured in ASH Plenary Session

Five Oral Presentations Highlight Kite’s Leadership in CAR T-Cell Therapies

New Research on Magrolimab Provides Key Insights as Gilead Rapidly Expands Research in AML

FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that data at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition (December 11-14) will showcase continued leadership across both approved and investigational CAR T-cell therapies and medicines. 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).

“This ASH 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’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 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-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: https://ash.confex.com/ash/2021/webprogram/start.html

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 Foster City, California.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com.

Gilead and Kite 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 Gilead and Kite’s ability to initiate, progress or clinical studies within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel and magrolimab; the possibility of unfavorable results from ongoing and additional clinical studies, including those involving axicabtagene ciloleucel and magrolimab; the possibility that Gilead and Kite may make a strategic decision to discontinue development of magrolimab and other investigational compounds and as a result, the compounds may never be successfully commercialized; 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 June 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Jacquie Ross, Investors
[email protected]

Mary Lynn Carver, Kite Media
[email protected]

Marian Cutler, Gilead Media
[email protected]

Source: Gilead Sciences, Inc.