Gilead-Kite Oncology to Present Transformative Science From Growing Portfolio at ASCO 2021

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that 16 abstracts representing the breadth of the Gilead-Kite Oncology portfolio will be presented at the American Society of Clinical Oncology Annual Meeting from June 4-8, 2021. The abstracts, including two oral presentations, expand on the clinical profiles of Gilead’s antibody-drug conjugate (ADC), as well as Kite’s chimeric antigen receptor (CAR) T-cell therapies across a range of cancers, including in existing indications and for investigational uses.

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“Gilead-Kite Oncology is rapidly advancing transformative science for people facing historically difficult-to-treat cancers,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Our first-in-class, TROP-2 directed ADC therapy is already having a meaningful impact for people with metastatic triple-negative breast and urothelial cancers, and data at ASCO will add further insight into its utility in TNBC in both monotherapy and future combination treatment approaches.”

“CAR T-cell therapy has changed the lives of patients suffering from certain forms of non-Hodgkin lymphoma, and our data at ASCO demonstrate important progress in extending the benefits to more patients in need,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “As we aim to bring CAR T to people with many different hematologic malignancies, we are just beginning to scratch the surface of what is possible.”

A list of accepted abstracts follows here:

Abstract Disposition

Abstract Title

Gilead Presentations

Oral #1011

6:00 am PT/9:00 am ET 

Outcomes in Patients Aged ≥65 Years in the Phase 3 ASCENT Study of Sacituzumab Govitecan (SG) in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1077

Assessment of Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) Cohort by Agent in the Phase 3 ASCENT Study of Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1080

Assessment of Sacituzumab Govitecan (SG) in Patients with Prior Neoadjuvant/Adjuvant Chemotherapy in the Phase 3 ASCENT Study in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS602

Phase 3 Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-Negative Breast Cancer Patients with High Relapse Risk After Standard Neoadjuvant Treatment – SASCIA

Poster #TPS1102

Saci-IO HR+: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1+ Hormone Receptor-Positive (HR+) / HER2- Metastatic Breast Cancer (MBC)

Poster #TPS1106 

Saci-IO TNBC: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1– Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS7055

Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher Risk Myelodysplastic Syndrome (MDS): The Phase 3, Randomized, ENHANCE Study

Poster #2559

GS-3583, a Novel FLT3 Agonist Fc Fusion Protein, to Expand Conventional Dendritic Cells in Healthy Volunteers

Poster #TPS3147

Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors

Kite Presentations

Oral #7002

11:30 am PT/2:30 pm ET

Phase 2 Results of the ZUMA-3 Study Evaluating KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)

Poster #7515

Outcomes in ZUMA-5 with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) Who Had the High-Risk Feature of Progression within 24 Months from Initiation of First Anti-CD20–Containing Chemoimmunotherapy (POD24)

Poster #7536

Favorable Tumor Immune Microenvironment (TME) and Robust Chimeric Antigen Receptor (CAR) T-Cell Expansion May Overcome Tumor Burden and Promote Durable Efficacy with Axicabtagene Ciloleucel (Axi-Cel) in Large B Cell Lymphoma (LBCL)

Poster #7547

Outcomes with KTE-X19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma (MCL) in ZUMA-2 Who Had Progression of Disease within 24 Months of Diagnosis (POD24)

Poster #7548

Updated Outcomes with Axicabtagene Ciloleucel (Axi-Cel) Retreatment in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) in ZUMA-5

Poster #7552

Real-World Evidence of Axicabtagene Ciloleucel (Axi-Cel) for the Treatment of Large B-Cell Lymphoma (LBCL) in the United States

Poster #e19548

Online Publication Only

Clinical Outcomes in Patients Relapsed/Refractory After ≥ 2 Prior Lines of Therapy for Follicular Lymphoma: A Systematic Literature Review and Meta-Analysis

All poster presentations will be made available on-demand beginning Friday, June 4 at 6:00 am PT/9:00 am ET.

For more information, including a complete list of abstract titles at the meeting, please visit: https://meetinglibrary.asco.org/.

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 biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

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 the possibility of unfavorable results from ongoing and additional clinical studies involving the Gilead-Kite Oncology portfolio and the possibility that Gilead and Kite may discontinue development at any time. 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 March 31, 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. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead 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.

Contacts:

Jacquie Ross, Investors
(650) 358-1054

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