Zimberelimab

– Late-Breaking Data from the Phase 3 ASCENT-04/KEYNOTE-D19 Study Evaluating Trodelvy® plus Keytruda® in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer – FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) will present more than 20abstracts across both Gilead and Kite at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting May 30 – June 3 and the 2025 European Hematology Association (EHA) Annual Congress June 12 – 15. The studies span breast cancer and other solid tumors (glioblastoma, endometrial cancer, lung cancer, gastric cancer), as well as multiple blood cancers (multiple myeloma, large B-cell lymphoma, indolent non-Hodgkin lymphoma, acute lymphoblastic leukemia). At ASCO, Gilead will present detailed late-breaking results from the Phase 3 ASCENT-04 study showing a statistically significant and clinically meaningful benefit in progression-free survival for Trodelvy® plus Keytruda® versus Keytruda and standard of care chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (Abstract #LBA109). Additionally, Kite research collaborators at the University of Pennsylvania Perelman School of Medicine will present Phase 1 results evaluating a novel investigational CAR T-cell therapy using a dual-target approach in patients with recurrent glioblastoma during an oral session at ASCO (Abstract #102). At EHA, Kite and its partner Arcellx will present updated findings from the Phase 2 registrational iMMagine-1 study of anitocabtagene-autoleucel (anito-cel) in relapsed/refractory multiple myeloma during an oral presentation (Abstract #S201). Additional abstracts supporting pipeline therapies (e.g., KITE-363, a C19/20 dual-target CAR T) and results from collaborative studies will also be presented as orals across ASCO and EHA. “Our oncology portfolio is broad and diverse by design, as we continue to innovate with next-generation therapies and combinations to deliver improved outcomes and ultimately seek to transform how cancer is treated,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “Data at ASCO and EHA will feature novel pipeline approaches with antibody-drug conjugate therapy and cell therapy, helping to drive oncology innovation and change medical practice.” Summary of Presentations Accepted abstracts at the 2025 ASCO Annual Meeting include: Tumor Types Abstract Title Metastatic Triple-Negative Breast Cancer Abstract #LBA109 May 31, 2025 3:35 – 3:47 PM CDT (Oral Presentation) Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro) vs Chemotherapy (Chemo) + Pembro in Previously Untreated PD-L1 Positive Advanced Triple-Negative Breast Cancer (TNBC): Primary Results from the Randomized Phase 3 ASCENT-04/KEYNOTE-D19 Study Abstract #511 June 1, 2025 8:12 – 8:18 AM CDT (Oral Presentation) A Phase 2 Study of Response-Guided Neoadjuvant Sacituzumab Govitecan and Pembrolizumab (SG/P) in Patients with Early-Stage Triple-Negative Breast Cancer: Results from the NeoSTAR Trial* Lung Cancer Abstract #8599 May 31, 2025 1:30 – 4:30 PM CDT (Poster) Longer Follow-up for Survival and Safety from the EVOKE-01 Trial of Sacituzumab Govitecan (SG) vs Docetaxel in Patients (pts) with Metastatic Non-small Cell Lung Cancer Abstract #8522 May 31, 2025 1:30 – 4:30 PM CDT (Poster) Exploratory ctDNA Analyses for the EVOKE-1 Study in Metastatic Non-small Cell Lung Cancer Abstract #11154 May 31, 2025 1:30 – 4:30 PM CDT (Poster) Characterizing Health Related Quality of Life Among Individuals Living with Non-Small Cell Lung Cancer in the United States: Findings from the Cancer Experience Registry Endometrial Cancer Abstract # e17624 May 22, 2025 4:00 PM CDT (Online Publication Only) Trop-2 Expression and its Prognostic Impact on Endometrial Cancer: A Real-world Data Analysis Glioblastoma Abstract #102 June 1, 2025 10:09 – 10:21 AM CDT (Oral Presentation) A Phase 1 Study of Intracerebroventricular Delivery of Bivalent CAR T-Cells Targeting EGFR and IL13Rα2 in Patients with Recurrent Glioblastoma** Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas Abstract #4033 May 31, 2025 9:00 AM – 12:00 PM CDT (Poster) Real-world Analyses to Evaluate the Role of TIGIT as a Target in First-line (1L) Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas Head and Neck Squamous Cell Carcinoma (HNSCC) Abstract # e18011 May 22, 2025 4:00 PM CDT (Trial in Progress [TiP], Online Publication Only) A Phase 2 Study of First-line Domvanalimab, Zimberelimab, and Chemotherapy in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Substudy-01 of the VELOCITY-HNSCC Platform Trial B-cell Lymphoma Abstract #7003 May 30, 2025 3:45 – 3:57 PM CDT (Oral Presentation) A Phase 1 Study of KITE-363 Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients (pts) with Relapsed/Refractory (R/R) B-cell Lymphoma Large B-cell Lymphoma Abstract #7023 June 1, 2025 9:00 AM – 12:00 PM CDT (Poster) Trends and Outcomes by Inpatient and Outpatient Infusion of Axicabtagene Ciloleucel (Axi-cel) in the US for Patients (Pts) with Relapsed / Refractory Large B-Cell Lymphoma Secondary Central Nervous System Lymphoma Abstract #2020 May 31, 2025 4:12 – 4:18 PM CDT (Oral Presentation) Using Single-Cell Transcriptomics to Reveal CD226 Upregulation and Enhancement of CD19-CAR-T Function in the Inhibitory CNS Microenvironment of Refractory CNS Lymphoma*** Abstract #7024 June 1, 2025 9:00 AM – 12:00 PM CDT (Poster) Real-world Outcomes of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapsed/Refractory (R/R) Secondary Central Nervous System Lymphoma *Collaborative study with Massachusetts General Hospital and Dana-Farber Cancer Institute **Collaborative study with the University of Pennsylvania Perelman School of Medicine ***Collaborative study with Dana-Farber Cancer Institute Summary of Presentations Accepted abstracts at the EHA 2025 Annual Congress include: Tumor Types Abstract Title Acute Lymphoblastic Leukemia Abstract #PF374 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Five-year 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 Large B-cell Lymphoma Abstract #PF1168 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Cost-effectiveness of Real-world Axicabtagene Ciloleucel Use in Relapsed/Refractory 2L LBCL Based on a Multi-center US Registry Abstract #PF1002 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq after Axicabtagene Ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-cell Lymphoma Abstract #PF1304 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Health Impact of Chimeric Antigen Receptor T-Cell Vein-to-Vein Time in Second-Line Large B-Cell Lymphoma Patients: An Exploratory Modelling Analysis for Italy Abstract #S237 June 13, 2025 5:00 – 6:15 PM CEST (Oral Presentation) Real-world Effectiveness and Safety Outcomes Among Key Subgroups of Second-line (2L) Axicabtagene Ciloleucel (Axi-cel) for Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL) Abstract # PB3232 May 14, 2025 (Publication Only) The Italian Commercial Axi-cel Manufacturing Performance: A Retrospective Analysis of an Efficient and Reliable Process Over Time Abstract # PB3238 May 14, 2025 (Publication Only) Clinical, Economic, and Humanistic Outcomes of First-line High-Risk Large B-Cell Lymphoma: A Series of Systematic Literature Reviews Mantle Cell Lymphoma Abstract #PF954 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): A Systematic Literature Review (SLR) And Meta-analysis Multiple Myeloma Abstract #S201 June 14, 2025 5:00 – 6:15 PM CEST (Oral Presentation) Phase 2 Registrational Study of Anitocabtagene-Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 Abstract #PF1294 June 13, 2025 6:30 – 7:30 PM CEST (Poster) Understanding Caregiver Challenges in Multiple Myeloma (MM): A Systematic Literature Review (SLR) of the Qualitative and Quantitative Literature Anitocabtagene autoleucel is an investigational therapy. Neither Kite or Arcellx has received approval from any regulatory authority for any use of this therapy, and its safety and efficacy has not been established. The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic TNBC is investigational, and the safety and efficacy of this use have not been established. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indications and additional Important Safety Information. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Trodelvy Trodelvy® (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 tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Indications for Trodelvy TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Important Safety Information for Trodelvy BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting.Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About Anitocabtagene autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. 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, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. 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 supply 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 unfavorable results from ongoing or additional clinical studies, including those involving Trodelvy, anito-cel, KITE-363 and a Phase 1 candidate in recurring glioblastoma (such as the ASCENT-04, iMMagine-1 and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; 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 are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, 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. Trodelvy, Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on X/Twitter (@KitePharma) and LinkedIn (Kite-Pharma). Blair Baumwell, Gilead Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com