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

Rhea-AI Summary

Gilead Sciences and Kite will showcase advancements in CAR T-cell therapies at the upcoming ASH Annual Meeting (Dec 11-14). Highlights include over 20 abstracts, with the landmark ZUMA-7 study presenting efficacy and safety results in relapsed/refractory large B-cell lymphoma (LBCL). Kite's research aims to improve treatment standards and patient survival rates. Additionally, new findings on investigational magrolimab will be discussed, indicating significant potential in AML treatments. Gilead emphasizes broad potential across its oncology pipeline amid evolving cancer treatment strategies.

Positive

• Presentation of ZUMA-7 study results indicates strong efficacy for axicabtagene ciloleucel in LBCL.
• Over 20 abstracts showcasing advancements in CAR T-cell therapies highlight Gilead's leadership.
• New research on magrolimab may enhance treatment options for acute myeloid leukemia.

Negative

• None.

– 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211104005797/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Mary Lynn Carver, Kite Media

mcarver@kitepharma.com

Marian Cutler, Gilead Media

marian.cutler1@gilead.com

Source: Gilead Sciences, Inc.

FAQ

What are the key highlights of Gilead's ZUMA-7 study at ASH 2021?

The ZUMA-7 study will present efficacy and safety results for axicabtagene ciloleucel in relapsed/refractory large B-cell lymphoma.

When will Gilead present its findings at the ASH Annual Meeting?

Gilead's presentations will take place from December 11 to December 14, 2021.

What is the significance of the research on magrolimab presented by Gilead?

The research on magrolimab may provide new insights and treatment options for acute myeloid leukemia, expanding Gilead's oncology portfolio.

How many abstracts will Gilead present at the ASH Annual Meeting?

Gilead will present over 20 abstracts highlighting advancements in CAR T-cell therapies.

What is Gilead's focus regarding cancer treatments?

Gilead is focused on advancing innovative medicines for blood cancers, aiming to change treatment standards and improve patient survival.