New ASCO and EHA 2026 Data Demonstrate Gilead and Kite’s Momentum Across Antibody-Drug Conjugates and Cell Therapy in Oncology

Key Terms

antibody-drug conjugates medical

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

car t-cell therapy medical

Car T-cell therapy is a medical treatment that uses a patient’s own immune cells, modified in a lab to better recognize and attack cancer cells. It is considered a breakthrough because it offers potentially long-lasting effects for certain types of cancer. For investors, its development and approval can signal advances in healthcare innovation and potential growth opportunities in the biotech sector.

progression-free survival medical

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

pfs2 medical

PFS2 measures how long a patient goes from the start of a trial treatment until the disease worsens a second time or until death, often counting time that includes the next line of therapy. For investors, PFS2 shows whether a treatment delivers lasting control beyond the first response—like timing how long a car runs before needing another major repair—and a longer PFS2 can indicate more durable clinical benefit and stronger commercial potential.

trop-2 medical

Trop-2 is a protein that sits on the surface of many cancer cells and helps relay growth signals; doctors and researchers measure it as a sign of tumor behavior and use it as a target for therapies. For investors, Trop-2 matters because drugs designed to bind that surface protein act like a specialized key fitting a lock on cancer cells—successful therapies or diagnostic tests tied to Trop-2 can drive clinical progress, regulatory decisions and commercial value in oncology-focused companies.

bcma medical

BCMA (B‑cell maturation antigen) is a protein that sits on the surface of certain cancer cells, especially those from a type of blood cancer, and acts like a visible target for therapies. Investors care because drugs that successfully hit this target—using approaches like engineered immune cells or targeted antibodies—can change treatment options and drive revenue, while trial results, safety, and approval prospects directly affect a company’s valuation.

fast track regulatory

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

orphan drug regulatory

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

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– ASCO Presentations on Trodelvy^® in First-line Metastatic Triple-Negative Breast Cancer and Anito-cel in Relapsed or Refractory Multiple Myeloma Build Toward Potential Commercial Launches –

– EHA Updates Include Durability of KITE-753, Kite’s Enhanced DuoCore™ CAR T-cell Therapy –

FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that together with Kite, a Gilead company, it will present more than 25 abstracts, including six oral presentations, at the 2026 ASCO Annual Meeting (May 29 – June 2) and the 2026 EHA 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.

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 and EHA 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 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’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 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 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 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.

About Gilead and Kite Oncology

Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

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. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

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 Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving anito-cel, sacituzumab govitecan-hziy and KITE-753 (such as ASCENT-03, ASCENT-04, iMMagine-3 and GEM-AnitoFIRST); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead 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, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, 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 Gilead assumes no obligation and disclaims 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).

View source version on businesswire.com: https://www.businesswire.com/news/home/20260520344508/en/

Priscilla White, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com

Source: Gilead Sciences, Inc.