GILEAD AND KITE ONCOLOGY TO SHOWCASE ADVANCES ACROSS THE PIPELINE AIMING TO ADDRESS UNMET NEEDS IN CANCER CARE AT ASCO 2023

GILEAD  AND  KITE  ONCOLOGY  TO  SHOWCASE  ADVANCES  ACROSS  THE  PIPELINE  AIMING  TO  ADDRESS  UNMET  NEEDS  IN  CANCER  CARE  AT  ASCO  2023

– Data Across 30 Abstracts Reinforce Leadership in Metastatic Breast Cancer and Demonstrate Breadth of Pipeline Across Lung, Haematologic, Genitourinary, Gastrointestinal, Gynaecological and Other Solid Tumours –

– Late-Breaking Presentation to Detail Overall Survival Results for Yescarta^® (axicabtagene ciloleucel) CAR T-Cell Therapy, Showing Statistical Improvement Over Standard of Care for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma – 

– Updated Interim Results from Phase 2 ARC-7 Study of Fc-Silent Anti-TIGIT Monoclonal Antibody, Domvanalimab to be Featured in Oral Presentation –

Stockley Park, UK – 17 May 2023 – Gilead Sciences, Inc. and Kite, a Gilead Company, will present 30 abstracts during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. These data reinforce the strength of Gilead and Kite Oncology’s transformative science in hard-to-treat cancers.

“The breadth of data being presented at ASCO is a testament to our commitment in helping to bring more life to people with cancer,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “We are determined to deliver the best outcomes for patients and are proud to highlight the pan-tumour efficacy of Trodelvy, as well as our growing presence across lung cancer and many other tumour types.”

New Data Reinforce Pan-Tumour Efficacy of Trodelvy^® (sacituzumab govitecan)

Final overall survival (OS) results from the Phase 3 TROPiCS-02 study for sacituzumab govitecan in HR+/HER2- metastatic breast cancer (mBC) will be presented in an oral session.  Gilead will also share data evaluating sacituzumab govitecan in metastatic urothelial cancer.  Additionally, Gilead will present the first Phase 2 data evaluating sacituzumab govitecan as a potential therapy in advanced endometrial cancer.

Kite Cell Therapies Continue to Advance the Standard of Care in Leukaemia and Lymphoma

A late-breaking oral presentation from the landmark Phase 3 ZUMA-7 study will highlight results from the analysis of overall survival (OS) with axicabtagene ciloleucel versus standard of care for initial treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) within 12 months of completion of first-line therapy. Further analysis of the pivotal ZUMA-3 study in adult B-cell acute lymphoblastic leukaemia, in addition to real-world evidence in follicular lymphoma and mantle cell lymphoma, will also be presented.

“The data that will be presented at ASCO represent another significant step forward in our goal of bringing the hope of survival to more patients through our innovative cell therapies,” said Frank Neumann, MD, PhD, Senior Vice President, Kite’s Global Head of Clinical Development. “We are particularly excited to share our overall survival data from the pivotal ZUMA-7 study for axicabtagene ciloleucel for initial treatment of relapsed/refractory large B-cell lymphoma, the first and only treatment in 30 years to demonstrate a statistically significant improvement in overall survival versus historical standard of care in this patient population.” 

Gilead Highlights Emerging Lung Cancer Pipeline, Progress in Solid Tumours

Beyond our ongoing late-stage development programme evaluating the investigational use of sacituzumab govitecan in non-small cell lung cancer (NSCLC), Gilead will highlight clinical data and trial updates from several other lung cancer trials. This includes an oral presentation with our partner Arcus Bioscience, on the updated interim analysis of ARC-7, which will detail updated efficacy and safety results for domvanalimab, an Fc-silent anti-TIGIT monoclonal antibody, in first-line NSCLC with PD-L1 tumour proportion score (TPS) ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations. ARC-7 is an approximately 150-patient randomised Phase 2 study evaluating domvanalimab plus anti-PD-1 antibody zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab alone. 

Further highlighting progress being made across Gilead’s oncology pipeline, trial updates will be shared from ongoing studies in lung cancer, triple-negative breast cancer, urothelial cancer and several other solid tumours.

Summary of Presentations

Accepted abstracts at the 2023 ASCO Annual Meeting include:

Domvanalimab, etrumadenant, magrolimab, zimberelimab and sacituzumab govitecan for NSCLC and endometrial cancer are investigational and are not approved by the U.S. Food and Drug Administration or any other regulatory authority. Their safety and efficacy have not been established.

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 tumour types, including in more than 90% of breast and bladder cancers. Sacituzumab govitecan is intentionally designed with a proprietary hydrolysable 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 October 2022, axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T cell therapy, was approved by the European Commission (EC) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.¹ In June 2022, axicabtagene ciloleucel was approved by the EC for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. In August 2018, axicabtagene ciloleucel was approved by the EC 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.¹

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, focused on cell therapy to treat and potentially cure cancer.  As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company.  Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.

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 unfavourable results from ongoing or additional clinical studies, including those involving domvanalimab, brexucabtagene autoleucel, Sacituzumab govitecan, axicabtagene ciloleucel and magrolimab; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programmes and, as a result, these programmes may never be successfully commercialised 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, 2023, 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.