On May 21, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that together with Kite, a Gilead company, it will present more than 25 abstracts, including six oral presentations, at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting (May 29 – June 2) and the 2026 EHA (Free EHA Whitepaper) Congress (June 11 – 14). These presentations underscore the increasing diversity of Gilead’s oncology portfolio and pipeline reflecting a growing body of evidence across both solid tumors and hematologic malignancies. Collectively, the data demonstrate Gilead and Kite’s leadership in antibody-drug conjugates (ADCs) and CAR T-cell therapy.
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Key presentations support continued momentum ahead of near-term potential launch opportunities, including new data analyses for Trodelvy (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) and anitocabtagene autoleucel (anito-cel), an investigational agent for relapsed or refractory multiple myeloma (RRMM). Together with abstracts addressing earlier-stage innovation, manufacturing experience and real-world evidence, these data highlight a portfolio that is increasingly positioned to deliver durable impact at scale.
"We are at a pivotal inflection point in the evolution of our oncology portfolio, with late-stage programs advancing alongside a rapidly maturing pipeline," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "The data we are presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight the trajectory we are building across antibody-drug conjugates and cell therapy, while reinforcing the clinical, manufacturing and operational foundation to sustain long-term leadership in oncology and deliver meaningful advances for people living with cancer."
Key presentations at ASCO (Free ASCO Whitepaper) include:
ASCENT-04 and ASCENT-03 Analyses: Gilead will present new analyses during oral sessions from the Phase 3 ASCENT-04 and ASCENT-03 studies that further define the clinical profile of Trodelvy with or without Keytruda (pembrolizumab) in first-line mTNBC, including evaluation of progression-free survival after next-line treatment (PFS2) in each study (Abstract #s LBA1000 and 1001). PFS2 is a measure that provides important context around durable, long-term clinical effect beyond the first progression. The ASCENT-04 PFS2 data for Trodelvy plus Keytruda will be shared as part of ASCO (Free ASCO Whitepaper)’s press program.
Anito-cel Clinical Trial Manufacturing: Kite will present for the first time data on the anito-cel clinical trial manufacturing experience in patients with RRMM with at least one prior therapy or newly diagnosed MM from the Phase 3 iMMagine-3 and the Phase 2 GEM-AnitoFIRST study in collaboration with the GEM/PETHEMA Foundation, respectively. These findings highlight manufacturing consistency and operational execution supporting broader clinical development (Abstract #2550).
CAR T for the Treatment of Recurrent Glioblastoma: Research collaborators at the University of Pennsylvania Perelman School of Medicine will deliver an oral presentation featuring updated Phase 1 data exploring CAR T-cell therapy in recurrent glioblastoma, reflecting continued progress in advancing cell therapy approaches in solid tumors (Abstract #2013).
Key presentations at EHA (Free EHA Whitepaper) include:
KITE-753 Phase 1 Study: Updated Phase 1 results for KITE-753, Kite’s enhanced DuoCore CAR T-cell therapy for relapsed/refractory B-cell lymphoma, showing encouraging safety and durability of efficacy results that support its continued development (Abstract #4208619).
Summary of Presentations
Accepted abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.ASCO.org and include:
Title
Abstract Details
Breast Cancer
Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro
Abstract #LBA1000
Oral Presentation
June 2, 2026
9:45 – 9:57 AM CDT
Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-03 study of participants (pts) with previously untreated metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) vs chemotherapy (chemo)
Abstract #1001
Oral Presentation
June 2, 2026
9:57 – 10:09 AM CDT
ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC)
Abstract #1013
Rapid Oral Presentation
May 31, 2026
11:30 – 11:36 AM CDT
ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i)
Abstract #1014
Rapid Oral Presentation
May 31, 2026
11:36 – 11:42 AM CDT
Using ML to predict rapid progression for patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with frontline (1L) CDK 4/6 inhibitors (CDK 4/6i)
Abstract #1025
Poster Presentation
June 1, 2026
1:30 – 4:30 PM CDT
Subgroup analysis of participants (pts) with HER2 IHC0 in the ASCENT-07 study of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (mBC)
Abstract #1065
Poster Presentation
June 1, 2026
1:30 – 4:30 PM CDT
Early deviations from guideline-concordant care in triple-negative breast cancer: A patient-reported analysis
Abstract #e13528
Online Publication Only
May 21, 2026
4:00 PM CDT
Real-world utilization of a patient-centric symptom management guide for metastatic breast cancer
Abstract #e23403
Online Publication Only
May 21, 2026
4:00 PM CDT
Ovarian Cancer
NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)
Abstract #5513
Rapid Oral Presentation
May 30, 2026
8:36 – 8:42 AM CDT
Multiple Myeloma
Anitocabtagene autoleucel (anito-cel) clinical trial manufacturing experience in patients with relapsed/refractory (RR) or newly diagnosed (ND) multiple myeloma (MM)**
Abstract #2550
Poster Presentation
May 30, 2026
1:30 – 4:30 PM CDT
Glioblastoma
Updated overall survival, safety, and neurologic function outcomes from a phase 1 trial of bivalent chimeric antigen receptor (CAR) T-cell therapy in recurrent glioblastoma (GBM)***
Abstract #2013
Rapid Oral Presentation
May 31, 2026
5:06 – 5:12 PM CDT
Large B-cell Lymphoma
KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL)
Abstract #TPS7098
Poster Presentation
June 1, 2026
9:00 AM – 12:00 PM CDT
Long-term real-world outcomes of axicabtagene ciloleucel (axi-cel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)
Abstract #7028
Poster Presentation
June 1, 2026
9:00 AM – 12:00 PM CDT
CAR T-cell Therapy Resource Utilization
Real-world healthcare resource utilization (HCRU) following chimeric antigen receptor (CAR) T-cell therapy in U.S. patients treated in new authorized treatment centers (ATCs) without FACT accreditation
Abstract #e19515
Online Publication Only
May 21, 2026
4:00 PM CDT
*In collaboration with Viver Health
**In collaboration with the GEM/PETHEMA Foundation
***Collaborative study with the University of Pennsylvania Perelman School of Medicine
Accepted abstracts at the 2026 EHA (Free EHA Whitepaper) Congress highlight Kite’s expertise in CAR T-cell therapy and include:
Title
Abstract Details
Large B-cell Lymphoma
A Phase 1 Study of KITE-753 in Patients (Pts) With Relapsed/Refractory (R/R) B-Cell Lymphoma: Updated Safety and Efficacy Results
Abstract #4208619
Poster Presentation
June 13, 2026
6:45 – 7:45 PM CEST
Axicabtagene Ciloleucel as Second-Line Treatment in Patients With Late-Relapsed Large B-Cell Lymphoma: Interim Analysis of the LATE-R Clinical Trial From the Spanish Lymphoma Group GELTAMO*
Abstract #4207969
Poster Presentation
June 12, 2026
6:45 – 7:45 PM CEST
Clinical and Economic Outcomes by Risk Group Among First-Line Patients With Large B-Cell Lymphoma in the United States—SEER-Medicare Data Analysis
Abstract #4210325
Publication Only
May 12, 2026
Real-World (RW) Treatment Patterns and Survival Outcomes in Patients (Pts) With Newly Diagnosed High-Risk (HR) Large B-Cell Lymphoma (LBCL)
Abstract #4206903
Poster Presentation
June 12, 2026
6:45 – 7:45 PM CEST
International Expert Consensus on Real-World CAR T-Cell Eligibility in Large B-Cell Lymphomas: An E-Delphi Study
Abstract #4206912
Poster Presentation
June 12, 2026
6:45 – 7:45 PM CEST
Global Variation in CAR T-Cell Therapy Practice Patterns for LBCL: Quantitative Research Findings
Abstract #4210262
Publication Only
May 12, 2026
Axicabtagene Ciloleucel for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Brazil: The Impact of CAR T-Cell Therapy Wait Time and Treatment Sequencing
Abstract #4210270
Publication Only
May 12, 2026
Cost-Effectiveness of Axicabtagene Ciloleucel for Treating Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma After First-Line Treatment
Abstract #4209065
Poster Presentation
June 13, 2026
6:45 – 7:45 PM CEST
Cost-Effectiveness of Axicabtagene Ciloleucel in Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal B-Cell Lymphoma After Two Lines of Systemic Therapy
Abstract #4207302
Poster Presentation
June 12, 2026
6:45 – 7:45 PM CEST
Mantle Cell Lymphoma
Biologic Correlates of Long-Term Response After Brexucabtagene Autoleucel Therapy in Mantle Cell Lymphoma: Product Phenotype, PK, and Baseline Features
Abstract #4208752
Poster Presentation
June 13, 2026
6:45 – 7:45 PM CEST
Acute Lymphoblastic Leukemia
Cost-Effectiveness Analysis of Brexucabtagene Autoleucel in Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukaemia in Singapore
Abstract #4209064
Poster Presentation
June 13, 2026
6:45 – 7:45 PM CEST
Non-Hodgkin Lymphoma
Follow-Up-Time-Adjusted Non-Relapse Mortality (NRM) in Patients With Non-Hodgkin Lymphoma Following Chimeric Antigen Receptor (CAR) T-Cell Therapy Within Clinical Trials
Abstract #4208663
Poster Presentation
June 13, 2026
6:45 – 7:45 PM CEST
Multiple Myeloma
Anitocabtagene Autoleucel Clinical Trial Manufacturing Experience in Patients With Relapsed/Refractory or Newly Diagnosed Multiple Myeloma**
Abstract #4209802
Publication Only
Cell Therapy Healthcare Resource Utilization
CAR T Cell Therapy in Clinical Routine: Quantification of Real-World Hospital Resource Use Across CAR T Care Pathway in Germany
Abstract #4207303
Poster Presentation
June 12, 2026
6:45 – 7:45 PM CEST
*Collaborative study with the Spanish Lymphoma Group GELTAMO
**In collaboration with the GEM/PETHEMA Foundation
The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.
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 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.
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.
About Anito-cel
Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in relapsed or refractory multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, D-Domain binder potentially enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the potential elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.
About KITE-753
KITE-753 is an investigational, bicistronic autologous CAR T-cell therapy engineered to potentially overcome tumor antigen heterogeneity and may prevent relapse. The KITE DuoCore construct uniquely combines anti-CD19 and anti-CD20 targeting with dual co-stimulation (CD28 and 4-1BB). KITE-753 utilizes a novel manufacturing process, aiming to preserve T-cell fitness.
U.S. 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.
U.S. 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.
(Press release, Gilead Sciences, MAY 21, 2026, View Source [SID1234665969])