Gilead and Kite Oncology Demonstrate Transformative Impact of Cell Therapy and Promise of Blood Cancer Portfolio at ASH 2022

Rhea-AI Summary

Gilead Sciences (NASDAQ: GILD) and Kite will present 30 data presentations, including critical updates on CAR T-cell therapies and investigational treatments at the 64th Annual ASH Meeting (December 10-13). Key highlights include three-year results from ZUMA-5 for indolent non-Hodgkin lymphoma and data on magrolimab's potential in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). This reinforces the efficacy of Gilead's therapies and their commitment to improving patient outcomes in blood cancers.

Positive

• Presentation of three-year results from ZUMA-5 in indolent non-Hodgkin lymphoma, potentially improving investor outlook.
• New real-world evidence supports the effectiveness of CAR T-cell therapy on patient outcomes, enhancing market confidence.
• Ongoing collaboration with MacroGenics to develop new therapies indicates potential for future growth.

Negative

• Risks associated with clinical trial timelines and uncertain outcomes can impact stock performance negatively.
• Dependence on the success of ongoing studies, including magrolimab, may introduce volatility.

-- New Long-Term Data Reinforce Durability of CAR T-Cell Therapy in Lymphoma and Leukemia --

-- New Real-World Evidence Shows Impact of CAR T-Cell Therapy on Patient Outcomes --

-- Updated Data From Magrolimab Studies Continue to Support Potential in MDS and AML --

FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will support 30 data presentations, including seven oral presentations in large B-cell lymphoma (LBCL), and two oral presentations on investigator-sponsored studies in acute myeloid leukemia (AML) during the 64^th Annual American Society of Hematology (ASH) Annual Meeting (December 10-13).

“Every year, we see more patients benefitting in profound ways from CAR T-cell therapy,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “The breadth of real-world evidence and multi-year follow-up in pivotal studies we present this year can reinforce physicians’ confidence in the durability and reliability of Kite’s CAR T-cell therapies.”

Key presentations for Kite’s CAR T-cell therapies include three-year results from ZUMA-5 in indolent non-Hodgkin lymphoma (iNHL) and exploratory data from the three-year results from ZUMA-2 in mantle cell lymphoma (MCL) and two-year results from ZUMA-3 in B-cell acute lymphoblastic leukemia (ALL). Additional Kite research will focus on new sub-analyses of ZUMA-7 in LBCL, and real-world experience studying the impact of time from leukapheresis to infusion on patient outcomes.

“We continue to grow the body of evidence for new therapeutic options that improve how we treat blood cancers, which include some of the most challenging tumors,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “With our recently announced collaboration with MacroGenics to develop their second-generation CD123 bispecific antibody, we are excited about our presence at ASH and the potential of our pipeline to improve patient outcomes across a variety of hematologic cancers.”

An oral presentation showcasing results from a Phase 1/2 study of our investigational, anti-CD47 immunotherapy, in combination with azacitidine and venetoclax in patients with newly diagnosed older/unfit AML and relapsed/refractory AML also will be presented. Dates and times for accepted abstracts and presentations of note are as follows:

Oral Presentations
Abstract Details	Titles
Large B-Cell Lymphoma
Abstract #259 Saturday, Dec 10 (2:00 pm ET / 11:00 am PT)	Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (axi-cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7
Abstract #261 Saturday, Dec 10 (2:30 pm ET / 11:30 am PT)	Durable Response to Axi-Cel CD19 Therapy is Associated with Activation and Clonotypic Expansion of the Native T Cell Repertoire
Abstract #262 Saturday, Dec 10 (2:45 pm ET / 11:45 am PT)	Patients with Deleterious Germline Variants in STXBP2 Develop Toxicity After CAR-T Cell Therapy With Axicabtagene Ciloleucel
Abstract #440 Sunday, Dec 11 (9:45 am ET / 6:45 am PT)	A Pilot Study of Axicabtagene Ciloleucel (axi-cel) for the Treatment of Relapsed/Refractory Primary and Secondary Central Nervous System Lymphoma (CNSL)
Abstract #659 Sunday, Dec 11 (5:30 pm ET / 2:30 pm PT)	Outcomes of Subsequent Anti-Lymphoma Therapies in Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (axi-cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7 Study
Abstract #765 Monday, Dec 12 (11:00 am ET / 8:00 am PT)	Outcomes of Axicabtagene Ciloleucel in Comparison with Chemoimmunotherapy (CIT) in an Elderly Population for Treatment of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) After Two or More Lines of Prior Therapy
Abstract #892 Monday, Dec 12 (12:30 pm ET / 9:30 am PT)	Hospital Costs and HCRU CAR T-Cell Therapy and Hematopoietic Cell Transplant (HCT) in Patients with LBCL in the US
Acute Myeloid Leukemia
Abstract #61 Saturday, Dec 10 (10:30 am ET / 7:30 am PT) **Investigator Sponsored Research **	Phase I/II Study of Azacitidine (AZA) with Venetoclax (VEN) and Magrolimab (Magro) in Patients (pts) with Newly Diagnosed (ND) Older/Unfit or High-risk Acute Myeloid Leukemia (AML) and Relapsed/Refractory (R/R) AML
Abstract #603 Sunday, Dec 11 (5:30 pm ET / 2:30 pm PT) **Investigator Sponsored Research **	Clinical Characteristics and Overall Survival Among Acute Myeloid Leukemia (AML) Patients with TP53 Gene Mutation (TP53m) or Chromosome 17p Deletion (17p del)
Poster Presentations
Large B-Cell Lymphoma
Abstract #2274 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	Real-World Patient-Reported Outcomes among Recipients of Axicabtagene Ciloleucel for R/R LBCL
Abstract #2022 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	The Real-World Use of Bridging Therapy (BT) in Relapsed or Refractory LBCL Patients Treated with CAR T-cell Therapy: A Systematic Literature Review
Abstract #1618 Saturday, Dec 10 (6:30 pm ET / 3:30 pm PT)	Magrolimab in Combination with Rituximab + Chemotherapy in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Abstract #3345 Sunday, Dec 11 (6:00 pm ET / 3:00 pm PT)	Real-world Impact of Time from Leukapheresis to Infusion (Vein-to-Vein Time) in Patients with R/R LBCL Treated with Axi-Cel
Abstract #3346 Sunday, Dec 11 (6:00 pm ET / 3:00 pm PT)	Network Meta-Analysis (NMA) of CART-Cell Therapy for the Treatment of R/R DLBCL After 2 Prior Treatments Using Published Comparative Studies
Abstract #4667 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel (axi-cel) in Patients (Pts) with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL): 2-Year Follow-Up of ZUMA-1 Cohort 6
Abstract #4635 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	ZUMA-19: A Phase 1/2 Study of Axicabtagene Ciloleucel Plus Lenzilumab in Patients with Relapsed or Refractory Large B-Cell Lymphoma
Relapsed/Refractory Mantle Cell Lymphoma
Abstract #4199 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	Assessment of Durable Responses After Brexucabtagene Autoleucel (KTE-X19) in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL)
Abstract #4627 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	A Comparison of Overall Survival with Brexucabtagene Autoleucel (Brexu-cel) CAR T-Cell Therapy (ZUMA-2) and Standard of Care (SCHOLAR-2) in Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (BTKi)
Leukemia
Abstract #1368 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	Updated Outcomes from the Historical Control Study SCHOLAR-3 Contextualizing ZUMA-3 Results of Brexucabtagene Autoleucel (KTE-X19) in Adult Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)
Abstract #3319 Sunday, Dec 11 (6:00 pm ET / 3:00 pm PT)	A Phase 1 Study of KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Abstract #3083 Sunday, Dec 11 (7:00 pm ET / 4:00 pm PT)	Nature of Clinical Response and Depth of Molecular Response in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Treated with Magrolimab with Azacitidine
Mantle Cell, Follicular, & Other Indolent B-Cell Lymphomas
Abstract #2038 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	A 3-Year Follow-up Comparison of Clinical Outcomes from ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma (R/R FL)
Abstract #1581 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	Chimeric Antigen Receptor T-Cell Therapy Setting of Care: A Retrospective Cohort Analysis of MCL and FL Patients in the US
Abstract #4861 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	Cost-effectiveness of Axi-Cel for Adult Patients with Relapsed or Refractory Follicular Lymphoma in the United States
Abstract #4660 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	3-Year Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (axi-cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)
Other Notable Data
Abstract #165 Saturday, Dec 10 (12:30 pm ET / 9:30 am PT)	Targeting CNS lymphoma with Intravenous Axi-Cel: Evidence for Transcriptional Evolution Towards a Prominent Interferon Signature in CAR-T Cells Trafficking to the Tumor Sit
Abstract #1981 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	Identification of IL-4 as a Key Regulator of CAR T-cell Exhaustion Using Functional Genomics and Correlates of the Zuma-1 Clinical Trial
Abstract #2039 Saturday, Dec 10 (5:30 pm ET / 2:30 pm PT)	Baseline CRP and Ferritin Identify Patients at High Risk of Poor Outcomes after Axicabtagene Ciloleucel Despite Corticosteroid Prophylaxis
Abstract #4610 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	Immunosuppressive monocyte modulation of CAR T cell functions and impact on response to CART19
Abstract #4284 Monday, Dec 12 (6:00 pm ET / 3:00 pm PT)	Patients of Minority Race or Ethnicity in the US Receiving CAR T-cell Therapy in Clinical Trials and in the Real-World: A SEER-based Simulation

For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2022/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 global 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.

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 the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Tecartus, Trodelvy, Yescarta and magrolimab; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, 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 Facebook, Twitter (@KitePharma), LinkedIn and YouTube.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005748/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Anna Padula, Kite Media

apadula@kitepharma.com

Cathy Cantone, Gilead Media

catherine.cantone@gilead.com

Source: Gilead Sciences, Inc.

FAQ

What is the significance of Gilead's new data presentations regarding CAR T-cell therapy?

Gilead's new data presentations at the ASH Meeting reinforce the durability and effectiveness of CAR T-cell therapies in treating blood cancers.

What are the key findings from Gilead's ZUMA-5 study presented at ASH?

The ZUMA-5 study presented three-year results indicating sustained efficacy in treating indolent non-Hodgkin lymphoma.

How does Gilead's collaboration with MacroGenics affect its pipeline?

The collaboration aims to develop a second-generation bispecific antibody, enhancing Gilead's therapeutic options for blood cancers.

What risks does Gilead face with its current clinical trials?

Gilead faces risks related to clinical trial timelines and potential unfavorable results that could affect its stock performance.