GILEAD AND KITE ONCOLOGY TO HIGHLIGHT BROAD AND DIVERSE ONCOLOGY PORTFOLIO AT ASCO 2024

– Non-Small Cell Lung Cancer Development Program Data to be Presented, Including the Phase 3 EVOKE-01 Study –

 

– Updated Results from Phase 2 EDGE-Gastric Study of Fc-Silent Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab, to be Presented –

 

– Pilot Study Results of Yescarta^® (Axicabtagene Ciloleucel) in Relapsed/Refractory Primary and Secondary Central Nervous System Lymphomas, an Area of Unmet Clinical Need, to be Presented Orally –

 

Stockley Park, UK – 7 May, 2024 – Gilead Sciences, Inc. and Kite, a Gilead Company, will present 18 abstracts during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showcase the ongoing commitment to developing differentiated approaches to transform how cancer is treated and span solid tumours and blood cancers, including lung, breast, gastrointestinal, colorectal, leukaemia and lymphoma.

 

New Data Provide Detail on Trodelvy^® (sacituzumab govitecan-hziy) in Non-Small Cell Lung Cancer (NSCLC)

Gilead is presenting primary results from the global Phase 3 EVOKE-01 study of sacituzumab govitecan-hziy versus docetaxel in patients with advanced or metastatic NSCLC that has progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. In addition, Gilead will present longer-term results from Cohort A of the Phase 2 EVOKE-02 study of sacituzumab govitecan-hziy in combination with KEYTRUDA^® (pembrolizumab) in first-line advanced or metastatic squamous/non-squamous PD-L1-high NSCLC.

 

Gilead Highlights Progress in Gastrointestinal Pipeline

An updated analysis from the Phase 2 EDGE-Gastric study will be featured as a rapid oral presentation in partnership with Arcus Biosciences. These longer-term efficacy and safety results for domvanalimab, an Fc-silent anti-TIGIT antibody, plus the anti-PD-1 antibody zimberelimab and chemotherapy, as a potential first-line treatment for upper gastrointestinal cancers, follow the encouraging ORR and six-month PFS rate results from the preliminary analysis presented during the November 2023 virtual ASCO Plenary Series.

 

Additionally, an oral presentation with our partner Arcus Biosciences will feature data from Cohort B of ARC-9, a Phase 1b/2 study evaluating the safety and efficacy of etrumadenant, a dual A2a/b adenosine receptor antagonist, plus zimberelimab, and FOLFOX/bevacizumab in third-line metastatic colorectal cancer (mCRC).

 

Gilead and Kite Showcase New Data on CAR T-cell Therapies

A pilot collaborative study evaluating Yescarta^® (axicabtagene ciloleucel) for the treatment of patients with relapsed/refractory (R/R) primary and secondary central nervous system lymphoma (PCNSL and SCNSL) will be presented orally. These updated data will highlight the efficacy and safety of Yescarta in this patient population with important unmet need.

 

Additionally, updated overall survival and safety outcomes for Tecartus^® (brexucabtagene autoleucel) from the pivotal Phase 1/2 ZUMA-3 trial, now with more than four years of follow up, will be presented. The ZUMA-3 trial has the longest follow-up in an adult-only study of a CAR T-cell therapy for R/R B-cell lymphoblastic leukaemia (B-ALL). These data continue to support the long-term survival and durability of brexucabtagene autoleucel. 

 

Summary of Presentations

 

Accepted abstracts at the 2024 ASCO Annual Meeting include:

 

Tumour Types	Abstract Title
B-cell Acute Lymphoblastic Leukaemia
Abstract # 6531 3 June, 2024 9:00 AM – 12:00 PM Central Daylight Time (CDT) / 16:00 – 19:00 CEST (Poster)	Long-term survival outcomes of patients (pts) with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-3
Biliary Tract Cancer
Abstract #TPS4195 1 June, 2024 13:30 – 16:30 CDT / 20:30 – 23:30 CEST (TiP)	Phase 2 study of gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) during first-line treatment of advanced biliary tract cancers (BTC) – Big Ten Cancer Research Consortium Study BTCRC-GI22-564
Breast Cancer
Abstract # 1 June, 2024 15:00-18:00 CDT / 22:00 – 01:00 CEST (Oral Presentation)	SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer*
Abstract #1101 2 June, 2024 9:00 AM – 12:00 PM CDT / 16:00 – 19:00 CEST (Poster)	Prevention of sacituzumab govitecan (SG)-related neutropenia and diarrhea in patients (pts) with triple-negative or HR+/HER2- advanced breast cancer (ABC) (PRIMED): a phase 2 trial**
Abstract #1075 2 June, 2024 9:00 AM – 12:00 PM CDT / 16:00 – 19:00 CEST (Poster)	Genomic alterations in DNA damage response (DDR) genes in HR+/HER2- metastatic breast cancer (mBC) and impact on clinical efficacy with Sacituzumab Govitecan (SG): biomarker results from TROPiCS-02 study
Abstract # June 2, 2024 9:00 AM – 12 PM CDT / 16:00 – 19:00 CEST (Poster)	Sequential combination of Sacituzumab Govitecan and PARP inhibitor Talazoparib in metastatic triple negative breast cancer (mTNBC): Results from the Phase II Study
Abstract #TPS1140 June 2, 2024 9:00 AM – 12 PM CDT / 16:00 – 19:00 CEST (TiP)	Trial in Progress: Phase I/II study of stereotactic radiation and sacituzumab govitecan with zimberelimab in the management of metastatic triple negative breast cancer with brain metastases
Central Nervous System Lymphoma
Abstract # 2006 3 June, 2024 8:00 – 11:00 CDT / 15:00 – 18:00 CEST (Oral Presentation)	A pilot study of axicabtagene ciloleucel (axi-cel) for the treatment of relapsed/refractory primary and secondary central nervous system lymphoma (PCNSL and SCNSL)*
Colorectal Cancer
Abstract #3508 2 June, 2024 8:00 – 11:00 CDT / 15:00 – 18:00 CEST (Oral Presentation)	Randomized phase 1b/2 study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC)
Gastroesophageal Cancers
Abstract #433248 1 June, 2024 12:30 – 13:30 CDT / 19:30 – 20:30 CEST (Oral Presentation)	EDGE-Gastric Arm A1: Phase 2 study of domvanalimab, zimberelimab, and FOLFOX in first-line advanced gastroesophageal cancer
Lung Cancer
Abstract #LBA8500 31 May, 2024 14:45 – 17:45 CDT / 21:45 – 00:45 CEST (Oral Presentation)	Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study
Abstract #8592 3 June, 2024 13:30 – 16:30 CDT / 20:30 – 23:30 CEST (Poster)	Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC): results from longer follow-up of Cohort A of EVOKE-02
Abstract #TPS8121 3 June, 2024 13:30 – 16:30 CDT / 20:30 – 23:30 CEST (TiP)	VELOCITY-Lung substudy-03: a phase 2 study evaluating safety and efficacy of domvanalimab (dom) + zimberelimab (zim) or zim alone in combination with chemotherapy (chemo) in the neoadjuvant phase and dom+zim or zim alone in the adjuvant phase in patients with resectable stage II-III non-small cell lung cancer (NSCLC)
Rare Genitourinary Tumours
Abstract # TPS4627 June 2, 2024 9:00 AM – 12 PM CDT / 16:00 – 19:00 CEST (TiP)	SMART: A phase ii study of sacituzumab govitecan (SG) with or without atezolizumab immunotherapy in rare genitourinary (GU) tumors such as small cell, adenocarcinoma, and squamous cell bladder/urinary tract cancer, renal medullary carcinoma (RMC) and penile cancer*
Solid Tumours
Abstract #3029 1 June, 2024 9:00 AM – 12:00 PM CDT / 16:00 – 19:00 CEST (Poster)	Pooled safety analysis of sacituzumab govitecan (sg) in multiple solid tumor types
Thyroid Cancer
Abstract # TPS6130 June 2, 2024 9:00 AM – 12:00 PM CDT  / 16:00 – 19:00 CEST (TiP)	Sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory thyroid carcinoma: The phase 2 SETHY, GETNE-T2318 trial
Urothelial Cancer
Abstract # e16500 23 May, 2024 16:00 CDT / 23:00 CEST (Online Publication Only)	Treatment patterns of metastatic urothelial cancer in the United States
Abstract # TPS4618 2 June, 2024 9:00 AM – 12:00 PM CDT / 16:00 – 19:00 CEST (TiP)	Sacituzumab govitecan (SG) plus enfortumab vedotin (EV) for metastatic urothelial carcinoma (mUC) treatment experienced (DAD) and with Pembrolizumab (P) in treatment naïve UC (DAD-IO)**

 

*Collaborative study with Dana-Farber Cancer Institute

**Collaborative study

 

Domvanalimab, zimberelimab and etrumadenant are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal and lung cancers have not been established.

 

Sacituzumab govitecan-hziy has not been approved by any regulatory agency for the treatment of metastatic NSCLC. Its safety and efficacy have not been established for this indication. Sacituzumab govitecan-hziy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhoea; please see below for the approved U.S. Indication and additional Important Safety Information.

 

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy 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, bladder, and lung cancers. Sacituzumab govitecan is intentionally designed with a proprietary hydrolysable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumour microenvironment through a bystander effect.

 

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. [i]

 

About Brexucabtagene Autoleucel

In December 2020, the European Commission (EC) 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. In August 2022, the EC approved brexucabtagene autoleucel for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.[ii]

 

About Axicabtagene Ciloleucel

Axicabtagene ciloleucel is a CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, 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; 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; adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.^[iii]

 

About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity. 

 

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab, as well as other investigational cancer immunotherapies and A2a/A2b adenosine receptor antagonist etrumadenant, in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

 

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumour types.

 

Zimberelimab is being evaluated in the U.S. and globally as a foundational PD-1 treatment option in multiple ongoing and planned early and late-stage clinical studies in combination with other immunotherapies, including investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and A2a/A2b adenosine receptor antagonist etrumadenant.  

 

Guangzhou Gloria Biosciences Co. Ltd., who holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin's lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

About Etrumadenant

Etrumadenant is an investigational small molecule, selective dual antagonist of the A2a and A2b receptors designed to prevent adenosine-mediated immunosuppression. Adenosine elicits its immunosuppressive effects within the tumor microenvironment by binding and activating adenosine-specific receptors expressed on the surface of tumor-infiltrating immune cells, which can help cancer cells evade host antitumor immunity. Once etrumadenant binds to the A2a and A2b receptors and blocks the immunosuppressive effects of adenosine, activation of antitumor immune cells may be restored, which could result in tumor cell death.

 

Etrumadenant is being evaluated in combination with other cancer immunotherapies, including the investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and PD-1 inhibitor zimberelimab, in certain types of non-small cell lung and colorectal cancers.

 

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, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017. 

 

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.  

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[i] European Medicines Agency. Trodelvy^® (sacituzumab govitecan) SPC. Available at: https://www.ema.europa.eu/en/documents/overview/trodelvy-epar-medicine-overview_en.pdf. Accessed May 2024

[ii] European Medicines Agency. Tecartus^® (brexucabtagene autoleucel) SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf Accessed May 2024.

[iii] 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 2024.