GILEAD AND KITE ONCOLOGY TO HIGHLIGHT ADVANCES SUPPORTING NEW INNOVATIONS IN CANCER CARE AT THE ASCO ANNUAL MEETING

GILEAD  AND  KITE  ONCOLOGY  TO  HIGHLIGHT  ADVANCES   SUPPORTING  NEW  INNOVATIONS  IN  CANCER  CARE  AT  THE  ASCO  ANNUAL  MEETING

– Late-Breaking TROPiCS-02 Study Results in Heavily Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients to be Featured in ASCO Press Programme –

–  New Sub-Analysis from Kite’s ZUMA-7 CAR T-cell Therapy Study in Patients Aged 65+ and Data by Tumour Burden Characteristics in Second-Line Large B-cell Lymphoma to be Presented –

– Diverse Hematologic Research to be Highlighted by Phase 1b Data in MDS and AML and New Real-World Outcomes by Race and Ethnicity for CAR T-cell Therapy –

Stockley Park, UK – 18 May, 2022 – Gilead Sciences, Inc. and Kite, a Gilead Company, today announced that more than 20 abstracts, including two oral presentations and four poster discussions, will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June, 2022. These data highlight promising targets across diverse tumour types and blood cancers, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic triple-negative breast cancer (TNBC), large B cell lymphoma (LBCL), myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) and mantle cell lymphoma (MCL).

“Gilead has built a diverse oncology pipeline guided by our strategic framework, with a focus on depth and breadth to address the greatest gaps in care for people with overlooked, underserved, and difficult-to-treat cancers,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Anchored by our Trop-2 directed antibody-drug conjugate, CAR T-cell therapies and investigational anti-CD47 antibody, these data reinforce the potential of our transformative science across multiple cancers.”

Driving Scientific Innovation in Breast Cancers with High Unmet Need

A late-breaking presentation on the TROPiCS-02 study will examine the investigational use of Gilead’s antibody-drug conjugate in heavily pre-treated patients with HR+/HER2- unresectable locally advanced or metastatic breast cancer, a population with significantly limited treatment options following endocrine resistance. The final data from the landmark ASCENT study in second-line metastatic TNBC will also be presented.

Advancing an Industry-Leading CAR T-cell Therapy Portfolio

New analyses of the Phase 3 ZUMA-7 trial will highlight results in patients aged 65+, as well as data on pre-treatment tumour burden characteristics and clinical outcomes. Additional presentations include real-world outcomes by race and ethnicity in LBCL and longer-term data from the ZUMA-3 and ZUMA-2 studies assessing the durability of response to CAR T-cell therapy in relapsed/refractory MCL and relapsed/refractory adult ALL, respectively.

“At Kite, our singular focus is on developing cell therapies to treat and potentially cure cancers,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “Our data at ASCO span multiple types of blood cancer and stages of treatment, reinforcing how our therapies are changing the way cancer is treated.”

Advancing Potential Treatment Approaches in MDS and AML

Results of our Phase 1b study evaluating an investigational anti-CD47 antibody in combination with azacitidine in high-risk MDS and in TP53-mutant AML will be presented. MDS and AML are blood cancers which have seen limited therapeutic advancements in the past decade, and Gilead data being presented at ASCO will reinforce the potential of harnessing the innate immunity of macrophages.

Summary of Presentations

Accepted abstracts at the 2022 ASCO Annual Meeting include (all times CDT):

For more information, including a complete list of abstract titles at the meeting, please visit: https://meetinglibrary.asco.org/. This site does not belong to Kite.

About Sacituzumab Govitecan

Sacituzumab govitecan is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Sacituzumab govitecan is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload.

In Europe, Sacituzumab govitecan is approved for the treatment of patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease.

About Axicabtagene Ciloleucel

In August 2018, axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T-cell therapy, received European Marketing Authorisation for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.[i]

About Brexucabtagene Autoleucel

In December 2020, the European Commission granted conditional Marketing Authorisation for brexucabtagene autoleucel, the first CAR T-cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.[ii]

Brexucabtagene Autoleucel, formerly KTE-X19, is not approved for use in adult patients (≥18 years old) with relapsed/refractory B-cell acute lymphoblastic leukaemia (R/R B-ALL). This use remains investigational, with its efficacy and safety not established in this setting.

About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is not approved for use in Europe. Its efficacy and safety have not been established.

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.

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 March 31, 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 involve risks and uncertainties, 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.

[i] European Medicines Agency. Yescarta^® (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed May 2022.

[ii] European Medicines Agency. Tecartus^® (autologous anti-CD19-transduced CD3+ cells) SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf. Accessed May 2022.