Business Wire | Nov 4, 2021 09:23AM EDT

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

Nov. 04, 2021

FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Nov. 04, 2021--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 TitlesDetails

Plenary Session

Large B-cellLymphoma

Abstract #2 Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy inSunday, Dec 12 Patients with Relapsed/Refractory Large B-Cell Lymphoma

(2:00 pm ET /11:00 am PT)

Oral Presentations

Large B-cellLymphoma Patient-Reported Outcomes in a Phase 3, Randomized, Open-LabelAbstract #430 Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/RefractorySunday, Dec 12 Large B-Cell Lymphoma (ZUMA-7)

(10:15 am ET /7:15 am PT)

Large B-cellLymphoma

Abstract #530 Real-World Outcomes of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma: Impact of Age and SpecificSunday, Dec 12 Organ Dysfunction

(4:45 pm ET /1:45pm PT)

Large B-cellLymphoma

Abstract #739 Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel as First-Line Therapy in Patients with High-RiskMonday, Dec 13 Large B-Cell Lymphoma

(2:45 pm ET /11:45 am PT)

Large B-cellLymphoma

Abstract #901 TNFR2 as a Target to Improve CD19-Directed CAR T-Cell Fitness and Antitumor Activity in Large B-Cell LymphomaMonday, Dec 13

(6:15 pm ET /3:15 pm PT)

Non-Hodgkin Long-Term Follow-Up Analysis of ZUMA-5: A Phase 2 Study ofLymphoma Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Indolent Non-Hodgkin LymphomaAbstract #93 Saturday, Dec11

(10:00 am ET / 7:00 am PT)

Investigator-Sponsored Research (ISR) Oral Presentation

Acute MyeloidLeukemia

Abstract #371 Phase I/II Study of Azacitidine with Venetoclax and Magrolimab in Patients with Newly Diagnosed Older/Unfit or High-Risk AcuteSunday, Dec 12 Myeloid Leukemia (AML) and Relapsed/Refractory AML

(9:30 am ET /6:30 am PT)

Poster Presentations

Large B-cellLymphomaAbstract #1764 Long-Term (4- and 5-Year) Overall Survival in ZUMA-1, theSaturday, Dec Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients11 with Refractory Large B-Cell Lymphoma (LBCL)

(5:30 pm ET /2:30 pm PT)

Large B-cellLymphomaAbstract #1424 Chimeric Antigen Receptor T-Cell Therapy Treatment Patterns: ASaturday, Dec Retrospective Cohort Analysis of Relapsed or Refractory Diffuse11 Large B-Cell Lymphoma Patients in the US

(5:30 pm ET /2:30 pm PT)

FollicularLymphomaAbstract #1350 Safety and Effectiveness of Idelalisib in Patients with DoubleSaturday, Dec Refractory Follicular Lymphoma: A Pan European Cohort of 24211 Patients(5:30 pm ET /2:30 pm PT)

Large B-cellLymphomaAbstract #2832 Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma:Sunday, Dec 12 One-Year Follow-Up of ZUMA-1 Cohort 6

(6:00 pm ET /3:00 pm PT)

Large B-cellLymphomaAbstract #151459 Profiling the Peripheral Blood Immune Cell Repertoire in Large B-Cell Lymphoma Patients Treated with CD19 CAR-TSunday, Dec 12

(6:00 pm ET /3:00 pm PT)

Large B-cellLymphoma

Abstract #2814 A Phase II Trial of Anakinra for the Prevention of CAR T-Cell Mediated NeurotoxicitySunday, Dec 12

(6:00 pm ET /3:00 pm PT)

Large B-cellLymphomaAbstract #2833 Prediction of Early Onset Cytokine Release Syndrome and Neurologic Events After Axicabtagene Ciloleucel in Large B-CellSunday, Dec 12 Lymphoma Based on Machine Learning Algorithms

(6:00 pm ET /3:00 pm PT)

FollicularLymphomaAbstract #3543 A Comparison of Clinical Outcomes from Updated ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5Monday, Dec 13 External Control Cohort in Relapsed/Refractory Follicular Lymphoma(6:00 pm ET /3:00 pm PT)

Mantle CellLymphoma

Abstract #3844 The Comparison of KTE-X19 to Current Standards of Care: A Pre-Specified Synthetic Control Study Utilizing IndividualMonday, Dec 13 Patient Level Data from Historic Clinical Trials (SCHOLAR-3)

(6:00 pm ET /3:00 pm PT)

Mantle CellLymphoma

Abstract #3849 Effects of Prior Exposure to Tec Kinase Inhibitors on KTE-X19 ProductsMonday, Dec 13

(6:00 pm ET /3:00 pm PT)

Trials-In-Progress (TiP)

MultipleMyeloma

Abstract #2757 A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple MyelomaSunday, Dec 12

(6:00 pm ET /3:00 pm PT)

Acute MyeloidLeukemia A Phase 2, Open-Label, Multiarm, Multicenter Study to EvaluateAbstract #3424 Magrolimab Combined with Antileukemia Therapies for First-Line, Relapsed/Refractory, or Maintenance Treatment of Acute MyeloidMonday, Dec 13 Leukemia

(6:00 pm ET /3:00 pm PT)

Acute MyeloidLeukemia A Phase 3, Randomized, Open-Label Study Evaluating the SafetyAbstract# 3426 and Efficacy of Magrolimab in Combination with Azacitidine in Previously Untreated Patients with TP53-Mutant Acute MyeloidMonday Dec 13 Leukemia

(6:00 pm ET /3:00 pm PT)

MyelodysplasticSyndrome

Abstract #7055 Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher-Risk (HR) Myelodysplastic Syndrome (MDS): TheMonday, Dec 13 Phase 3 Randomized, ENHANCE Study

(6:00 pm ET /3:00 pm PT)

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 ofGilead 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.

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CONTACT: Jacquie Ross, Investors investor_relations@gilead.com

CONTACT: Mary Lynn Carver, Kite Media mcarver@kitepharma.com

CONTACT: Marian Cutler, Gilead Media marian.cutler1@gilead.com