On May 21, 2026 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present new findings at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where the cancer center will showcase 49 abstracts spanning solid tumors and blood cancers.

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This year’s research, to be presented in Chicago from May 29 to June 2, reflects growing efforts to tailor cancer treatment based on tumor biology, prior therapies and patient-specific factors that influence response.

"Cancer care is entering a new phase where understanding the biology of each patient’s disease is just as important as the treatment itself," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive. "The research we are presenting at ASCO (Free ASCO Whitepaper) demonstrates how precision medicine is becoming a reality across cancer types, and how we can use that insight to deliver smarter therapies, improve outcomes and move the field forward."

City of Hope featured oral presentations

4519: Gut microbiome patterns linked to response to immunotherapy in advanced kidney cancer
7007: Targeted antibody combination shows improved outcomes in patients with relapsed large B-cell lymphoma (SUNMO study subgroup analysis)
4015: Experimental therapy targeting a key cancer growth pathway in advanced liver cancer
5014: First-in-human study of a novel targeted therapy for advanced prostate cancer
Microbiome insights may help predict immunotherapy benefit in kidney cancer

City of Hope researchers report that gut microbiome composition may influence how patients respond to immunotherapy combinations in metastatic renal cell carcinoma, pointing to a potential biomarker that could help guide treatment selection in the future.

The microbiome is a rising focus at City of Hope, highlighted by a recent symposium that convened federal health leaders and top cancer centers to accelerate progress in the field.

The study findings come from a combined analysis of two randomized phase 1 trials evaluating standard-of-care immune checkpoint inhibitor regimens with or without the addition of CBM5881, a live biotherapeutic designed to modulate the gut microbiome. The trials enrolled treatment-naïve patients with metastatic disease who received either nivolumab plus ipilimumab or nivolumab plus cabozantinib, reflecting commonly used immunotherapy-based frontline options.

Across the combined dataset, patients who received CBM588 in addition to immunotherapy achieved an objective response rate of 66.7%, compared with 20% among those receiving standard therapy alone. Median progression-free survival improved to 32.1 months with the combination versus 3.7 months with standard treatment.

Researchers also used a metagenomic measure called TOPOSCORE to assess gut imbalance and found that patients with a more disrupted microbiome saw the greatest benefit. In this subgroup, progression-free survival increased from 2.8 months to 24.9 months with the addition of CBM588. The association between microbiome profile and treatment response was particularly evident in patients who received nivolumab plus ipilimumab, suggesting that the microbiome may interact differently depending on the immunotherapy backbone.

The new data support a growing body of research linking the gut microbiome to immune response.

"These findings suggest the microbiome may play a direct role in shaping immunotherapy outcomes," said Rahul Winayak, M.D., postdoctoral fellow at City of Hope. "If validated in larger studies, this approach could help guide treatment decisions and improve outcomes for patients with kidney cancer."

A randomized phase 3 trial is underway to further evaluate this strategy.

Bispecific antibody combination improves outcomes for patients with lymphoma, including in earlier lines of therapy

Updated data from the phase 3 SUNMO trial continue to show that the combination of mosunetuzumab, a bispecific antibody, and polatuzumab vedotin, an antibody-drug conjugate, improves outcomes for patients with relapsed or refractory large B-cell lymphoma who are not eligible for autologous stem cell transplant.

The study randomized patients to receive the combination regimen or standard chemotherapy with rituximab, gemcitabine and oxaliplatin. With a median follow-up of more than two years, the combination demonstrated an objective response rate of 70.3%, compared with 40.0% for standard therapy, along with a significant reduction in the risk of disease progression.

A key focus of this updated analysis was outcomes by line of therapy. Among patients who received treatment in the second-line setting, the combination produced higher response rates, deeper remissions and longer durations of response compared with both later-line patients and those who received chemotherapy. Median progression-free survival and duration of complete response were not reached in several subgroups, underscoring the durability of benefit.

The safety profile remained stable with longer follow-up, with low rates of higher-grade cytokine release syndrome and no observed neurotoxicity. These findings support use of this novel regimen in patients who are unable to tolerate aggressive chemotherapy.

"These results support the growing role of bispecific antibody-based combinations as an alternative to traditional chemotherapy," said Elizabeth Budde2, M.D., Ph.D., executive medical director of the Enterprise Immune Effector Cell Program at City of Hope. "We are especially encouraged by the durability of responses in earlier lines of therapy, where improving long-term outcomes is critical for every patient."

New therapy targeting a key cancer growth pathway shows promise in advanced liver cancer

City of Hope investigators are evaluating tegavivint, a first-in-class small-molecule inhibitor that targets the Wnt/β-catenin signaling pathway, a key driver in many liver cancers that have historically been difficult to treat.

The ongoing phase 1/2 study includes patients with advanced hepatocellular carcinoma who have received at least one prior line of systemic therapy and have disease that cannot be treated with surgery or localized therapies.

Among patients with Wnt pathway mutations detected with molecular profiling and treated within the recommended dose range, the therapy demonstrated clinical activity, with an objective response rate of 22%, disease control rate of 89% and median progression-free survival of eight months in patients treated earlier in their disease course.

Importantly, the study showed evidence of target engagement, including reductions in alpha-fetoprotein levels and changes in Wnt pathway circulating tumor DNA allele frequency. These findings suggest that the drug is affecting the intended biological pathway, a key challenge in prior efforts to target Wnt signaling.

"Targeting the Wnt pathway has long been a major challenge in oncology, but these data suggest we may finally be making progress," said Daneng Li, M.D., gastrointestinal medical oncologist at City of Hope. "With further validation, this approach could meaningfully expand treatment options and provide a potential targeted therapy approach to improve outcomes for patients with advanced liver cancer."

First-in-human study shows early activity for novel prostate cancer therapy

City of Hope researchers are presenting early results from a first-in-human study of ABBV-969, a dual-targeting antibody-drug conjugate that binds PSMA and STEAP1, two proteins commonly found in advanced prostate cancer. The therapy is designed to deliver a potent anti-cancer agent directly to tumor cells expressing PSMA and/or STEAP1 antigens.

The phase 1 study enrolled patients with metastatic castration-resistant prostate cancer who had received multiple prior lines of therapy, including androgen receptor pathway inhibitors and taxane-based chemotherapy to stop cell division. Patients were treated across a range of dose levels to evaluate safety, pharmacokinetics and preliminary efficacy.

Among patients with measurable disease, the therapy achieved an objective response rate of 45%, with responses observed across multiple dose levels starting at 3 mg/kg. Reductions in prostate-specific antigen (PSA) levels were also common, with 67% of patients achieving a PSA50 response and 28% achieving deeper PSA declines of 90% or greater.

The study assessed a range of doses and dose optimization is ongoing. The study also demonstrated a manageable safety profile. The most common higher-grade adverse events were hematologic, including anemia, which were generally reversible and consistent with the drug’s mechanism of action.

"We are seeing early signals that this targeted approach can deliver meaningful responses, even in heavily pretreated patients," said Tanya Dorff3, M.D., F.A.S.C.O., genitourinary medical oncologist at City of Hope. "The next step will be to better understand how to position this therapy to further improve outcomes."

(Press release, City of Hope, MAY 21, 2026, View Source [SID1234665973])

On May 21, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported new retrospective data showing that Noetik’s artificial intelligence-based TARIO-2 model identified spatial tumor microenvironment patterns associated with clinical outcomes from routine pretreatment tumor pathology images in patients treated with botensilimab (BOT) plus balstilimab (BAL), Agenus’ investigational next-generation multifunctional, Fc-enhanced anti-CTLA-4 and anti-PD-1 immunotherapy combination.

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The data will be presented on May 30, 2026, by Ryan Dalton, Ph.D., of Noetik, during a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation, titled "Artificial intelligence foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images," evaluated whether Noetik’s TARIO-2 model could analyze standard hematoxylin and eosin (H&E) pathology images to identify spatial tumor microenvironment patterns associated with clinical outcomes following treatment with BOT+BAL.

BOT is an Fc-enhanced anti-CTLA-4 antibody designed to broaden anti-tumor immune activity through effects on T-cell priming, antigen presentation and regulatory T cells within the tumor microenvironment. Given BOT+BAL’s differentiated mechanism and prior observations that clinical activity is not strongly associated with traditional biomarkers such as PD-L1 expression or tumor mutational burden, broader tumor microenvironment-based approaches may be important for identifying patients most likely to benefit.

The analysis included 113 efficacy-evaluable patients treated with BOT+BAL in the C-800-01 Phase 1b trial who had available pretreatment H&E images. Tumor cohorts included microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases, ovarian cancer and sarcomas. The analysis evaluated TARIO-2’s ability to predict clinical endpoints including best overall response and overall survival.

In the MSS mCRC without active liver metastases cohort, TARIO-2 demonstrated statistically significant predictive performance for both best overall response and overall survival. Supportive trends were observed in the ovarian cancer and sarcoma cohorts. In the MSS mCRC without active liver metastases cohort, TARIO-2 also outperformed benchmark pathology foundation models in predicting best overall response and overall survival.

TARIO-2 does not rely on a traditional single-marker biomarker approach. Instead, the model applies AI-based spatial tumor microenvironment analysis to standard H&E pathology images, which are routinely generated during cancer diagnosis and clinical evaluation. By using widely available H&E images, TARIO-2 is designed to extract biologically relevant tumor microenvironment features without requiring more complex tissue-profiling approaches that may be difficult to implement routinely. This approach may support future patient stratification strategies if prospectively validated.

"Routine pathology images are already part of cancer care, but much of the biologic information they contain is difficult to interpret by eye alone," said Ryan Dalton, Ph.D., Senior Computational Scientist at Noetik. "These data suggest that AI-based analysis of pretreatment H&E images may help identify spatial tumor microenvironment patterns associated with clinical benefit from BOT+BAL. The findings support prospective validation of TARIO-2 as a practical, image-based biomarker strategy."

BOT+BAL is being evaluated as a novel immunotherapy combination designed to expand immune activity in tumors that have historically been difficult to treat with conventional immunotherapies. The ability to better understand which patients are most likely to benefit remains an important area of translational research, particularly in tumor types with limited immunotherapy options.

"BOT+BAL is designed to engage the immune system in tumors that have historically been resistant to conventional immunotherapy, through differentiated mechanisms not fully captured by traditional biomarkers such as PD-L1 expression or tumor mutational burden," said Dhan Chand, Ph.D., Vice President of Research at Agenus. "These data represent an important step toward aligning BOT+BAL’s differentiated biology with the patients most likely to benefit. Prospective validation will be an important next step as we continue to advance BOT+BAL clinical development."

The findings support prospective validation of TARIO-2 as an H&E-based biomarker strategy for BOT+BAL, including further evaluation in MSS colorectal cancer and broader solid tumor datasets.

Following the poster session on May 30, 2026, the full poster will be available on the Publications page of the Agenus website.

Presentation Details

Abstract Title: Artificial intelligence (AI) foundation model as a predictor of efficacy of next-generation checkpoint inhibition with botensilimab (BOT) + balstilimab (BAL) in solid tumors using pretreatment H&E images
Abstract No.: 2535
Presenter: Ryan Dalton Ph.D., Sr. Computational Scientist, Noetik
Session Title: Poster Session – Developmental Therapeutics—Immunotherapy
Location: Hall A – Posters and Exhibits
Poster Board: 325
Date/Time: May 30, 2026, 1:30 PM–4:30 PM CDT

(Press release, Agenus, MAY 21, 2026, View Source [SID1234665972])

On May 21, 2026 858 Therapeutics, a clinical-stage biotechnology company, reported preliminary safety and efficacy data from its ongoing, first-in-human Phase 1/2 trial of PARG inhibitor ETX-19477. These data will be presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, May 30.

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The ASCO (Free ASCO Whitepaper) abstract released today includes clinical data from 45 patients enrolled in the Phase 1a/b dose escalation and expansion portions of the study. The poster presentation will feature an expanded dataset of 53 patients, including seven patients who meet the eligibility criteria for the ongoing Phase 2 expansion cohorts in BRCA-mutated ovarian cancer and HR+/HER2- breast cancer. These criteria limit prior therapy to no more than five lines for ovarian cancer and no more than two lines for breast cancer. In this Phase 2-eligible subset, ETX-19477 demonstrated robust antitumor activity, with a 57% objective response rate (n=7). Durable RECIST responses were observed in both tumor types, providing the first clinical proof-of-concept for PARG inhibition in ovarian and breast cancer patients. ETX-19477 was generally well tolerated, with low rates of hematologic toxicity observed to date.

"These data represent an important clinical milestone for ETX-19477 and for the emerging field of PARG inhibition," said Jeffrey A. Stafford, CEO of 858 Therapeutics. "We are encouraged by the clinical efficacy and RECIST responses observed to date, in both ovarian and breast cancer patients. These treatment outcomes, together with the robust PK-PD relationship established during dose escalation, support the continued development of ETX-19477, including combination approaches that can meaningfully expand the patient populations treatable with ETX-19477."

858 Therapeutics is actively enrolling patients in Phase 2 monotherapy expansion cohorts, with a focus on BRCA-mutated ovarian and breast cancer. Additional details on the ETX-19477 clinical program can be found on clinicaltrials.gov (NCT06395519).

ASCO Presentation Details

Title: First-in-human phase 1/2 study of ETX-19477, an oral, potent, and selective PARG inhibitor, in patients with advanced solid tumors (ERADIC8)
Abstract Number: 3109
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: Saturday, May 30, 2026, 1:30 PM-4:30 PM CDT
Presenter: Ezra Rosen, M.D., Ph.D., Memorial Sloan Kettering Cancer Center, New York, NY

About ETX-19477

Poly(ADP-ribose) glycohydrolase (PARG) is an enzyme that catalyzes the removal of poly-ADP-ribose (PAR) chains from proteins during the DNA damage response. PARG inhibition leads to selective cell death in tumors with underlying replication fork defects, including BRCA-mutated tumors, through a mechanism distinct from PARP inhibition. ETX-19477 is an oral, potent, and selective PARG inhibitor that is efficacious in preclinical mouse models of ovarian, breast, and gastric cancers. 858 Therapeutics is evaluating ETX-19477 in a Phase 1/2 study in patients with advanced solid tumors at multiple sites in the U.S. For more information on the Phase 1/2 study, please visit: View Source

(Press release, 858 Therapeutics, MAY 21, 2026, View Source [SID1234665971])

On May 21, 2026 Flatiron Health reported its presence at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting happening from May 29 – June 2, 2026, in Chicago, Illinois. Flatiron’s high-quality real-world data and innovative research capabilities are featured across 25+ research acceptances, including 14 Flatiron-authored poster presentations and online publications.

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Flatiron’s presence at ASCO (Free ASCO Whitepaper) 2026 closely follows the launch of Flatiron Telescope, a multi-agent adaptive analytics platform designed to help life sciences teams find the right patients faster, assess study feasibility in real time, and generate oncology insights on demand. Flatiron Telescope will be demonstrated at the company’s booth (#21149) for attendees to build and iterate on patient cohorts using natural language and generate insights in real time.

"Our presence at ASCO (Free ASCO Whitepaper) 2026 proves that innovation and rigor aren’t at odds—they reinforce each other," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "From digital twins that simulate patient outcomes to LLM-enabled treatment pattern analysis, our work demonstrates that Flatiron is defining—not just participating in—the evolution of oncology evidence. These 25+ acceptances showcase our unified, global oncology engine and reinforce our position as the gold standard in oncology intelligence, trusted to guide the highest-stakes decisions across the industry."

Research highlights include:

Digital twin modeling for treatment prediction: validating novel counterfactual prediction approaches in NSCLC using clinical trial data, demonstrating how AI-enabled simulation can move beyond observational analysis to model patient outcomes under different treatment scenarios
Physician adoption of landmark clinical trial findings: a large-language model-based analysis documenting how ASCO (Free ASCO Whitepaper) plenaries translate to clinical decision-making in real-world practice, the largest such analysis of clinician-patient trial discussions to date
Recurrence risk prediction in early breast cancer: leveraging multi-site observational data to build predictive models for early breast cancer populations, showing how scale enables discovery in underrepresented patient groups
Post-operative circulating tumor DNA as a prognostic indicator: examining ctDNA’s role in identifying high-recurrence risk in muscle-invasive and locally advanced bladder cancer, demonstrating the value of real-world biomarker data in routine practice
Real-world treatment patterns in platinum-resistant ovarian cancer: analyzing platinum re-challenge outcomes in a population with limited evidence guidance, highlighting how Flatiron’s depth of longitudinal data reveals clinical practices that diverge from trial design and guidelines
Join Flatiron Health at booth #21149 for a demo of Flatiron Telescope and follow Flatiron Health on X and LinkedIn for more updates from #ASCO26.

Poster Presentations
From plenary to practice: a large language model (LLM)-based thematic analysis of landmark clinical trial discussions and factors influencing their real-world adoption
Aaron B Cohen, Tori Williams, Charu Aggarwal, Angela M DeMichele, Ritvik Vasudevan, Niquelle Brown Wadé, Shreya Balakrishna Rosseau, Erin Fidyk, Blythe Adamson
Author affiliations: Penn Medicine, Flatiron Health
Abstract Number: 1583
Poster Session: Care Delivery/Models of Care
Poster Board: 501
Date and Time: May 30, 2026, 9-12 PM

External validation of a deep learning CT biomarker to predict first-line immune checkpoint inhibitor monotherapy-associated survival in PD-L1-high metastatic non-small cell lung cancer
Ravi B. Parikh, Jacqueline Law, Lauren M. Damato, Paul M. Novotny, Joel Brooks, Ryan Beasley, Chiharu Sako, Petr Jordan, George R. Simon
Author affiliations: Emory University, Onc.AI, OhioHealth, Flatiron Health
Abstract Number: 2534
Poster Session: Developmental Therapeutics—Immunotherapy
Poster Board: 324
Date and Time: May 30, 2026, 1:30- 4:30 PM

Prognostic value of post-operative circulating tumor DNA (ctDNA) in real-world treatment and outcomes among patients (pts) with muscle invasive (MIBC) and locally advanced (LA) bladder cancer (BC)
Khilna Patel, Danni Zhao, Erin Fidyk, Eunice A. Hankinson, Aashay Mahesh Mehta, Matthew Pesavento, Arun Sujenthiran
Abstract Number: 4600
Poster Session: Genitourinary Cancer—Kidney and Bladder
Poster Board: 79
Date and Time: May 31, 2026, 9-12 PM

Real-world second-line treatment patterns and outcomes by platinum sensitivity in extensive-stage small cell lung cancer in the post-immunotherapy era
Catherine Rinaldi, Samantha Reiss, Jenna Collins, Karen Schwed, Michael Chiu, Emily Castellanos
Abstract Number: 8083
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Poster Board: 557
Date and Time: May 31, 2026, 9-12 PM

Comparison of real-world overall survival between atezolizumab- and durvalumab-containing first-line induction and maintenance regimens in extensive-stage small cell lung cancer
Apar Kishor Ganti, Jeremy Snider, Jessie T. Yan, Catherine Rinaldi, Amy Nguyen, Badri Rengarajan, Deb Profant, Douglas S. Fuller, Ellen Hu, Trong Kim Le, Navit Naveh, Xiaozhou Fan
Author affiliations: Jazz Pharmaceuticals, Nebraska Western Iowa Health Care System/University of Nebraska Medical Center, Flatiron Health
Abstract Number: 8093
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Poster Board: 567
Date and Time: May 31, 2026, 9-12 PM

A risk stratification schema for patients with non-small cell lung cancer with multiple organ metastases
Gabriela Esnaola, Mengru Wang, Benjamin Resio, Alexander Pan, Daniel Lee, Aaron B. Cohen, Maneet Kaur, Madeleine Schmitter, Jeffrey J. Ishizuka, Kelly Olino
Author affiliations: Yale School of Medicine, Dana-Farber Cancer Institute, Flatiron Health
Abstract Number: 11138
Poster Session: Quality Care/Health Services Research Track
Poster Board: 121
Date and time: June 1, 2026, 9-12pm

Platinum re-challenge in platinum-resistant ovarian cancer: real-world patterns and outcomes
Prakirthi Yerram, Matt Bye, Khilna Patel, Nicole Nasrallah, Michael Curry, Emily Castellanos
Abstract Number: 5566
Poster Session: Gynecologic Cancer
Poster Board: 232
Date and Time: June 1, 2026, 9-12pm

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)
Michael Peng, Gabriel Rios, Melissa Estevez, Jamie Colasurdo, Mohammad Forouzanfar, Kelly Hoang, Meng Wang
Author affiliations: Gilead Sciences, IQVIA, Flatiron Health
Abstract Number: 1025
Poster Session: Breast Cancer—Metastatic
Poster Board: 139
Date and Time: June 1, 2026, 1:30-4:30 PM

RW post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with HR+/HER2− metastatic breast cancer (MBC) in US.
Vk Gadi, Lowell L. Hart, Paolo Tarantino, Priyanka Sharma, Sarah L. Sammons, Panagiotis Mayros, Maneet Kaur, Nada Boualam, Catherine Keane, Gary M. Sopher, Purnima Pathak, Hope S. Rugo
Author affiliations: University of Illinois Cancer Center, Wake Forest University/Florida Cancer Specialists, Harvard Medical School, University of Kansas Medical Center, Dana-Farber Cancer Institute, Novartis, City of Hope Comprehensive Cancer Center, Flatiron Health
Abstract Number: 1073
Poster Session: Breast Cancer—Metastatic
Poster Board: 187
Date and Time: June 1, 2026, 1:30-4:30 PM

Recurrence risk prediction using a large, multi-site observational dataset of patients with early breast cancer including early-onset disease
Lilia Bouzit, Gabriel Rios, Smriti Karwa, Erin Fidyk, Catherine Keane, Melissa Estevez
Abstract Number: 547
Poster Session: Cancer—Local/Regional/Adjuvant
Poster Board: 32
Date and Time: June 1, 2026, 1:30-4:30 PM

Online Acceptances
Digital twin models for counterfactual prediction in NSCLC: a validation study using clinical trial data
Aaron B Cohen, Sandra Giffith, Melissa Estevez, Brandon Arnieri, Matt H Secrest, Joe Manfredonia, Marcello Ricottone, Richard Knoche, Jacqueline Law, Melina Marmarelis
Author affiliations: Genentech, University of Pennsylvania, Flatiron Health
Abstract Number for Publication: e20517

Real-world treatment patterns and outcomes among patients with high-risk and very high-risk non-metastatic prostate cancer
Eunice A. Hankinson,Yunzhi Qian, Patrick Ward, Khilna Patel, Aaron Dolor, Arun Sujenthiran
Abstract Number for Publication: e17120

Drivers of organotropism and patterns of metastatic progression in metastatic non-small cell lung cancer
Gabriela Esnaola, Benjamin Resio, Alexander Pan, Daniel Lee, Aaron B. Cohen, Mengru Wang, Madeleine Schmitter, Jeffrey J. Ishizuka, Kelly Olin
Author affiliations: Yale School of Medicine, Dana-Farber Cancer Institute, Flatiron Health
Abstract Number for Publication: e20541

Real-world biomarker testing rates, targeted therapy use, and clinical outcomes in patients with advanced gastric or GEJ cancer in the United States
Lauren Damato, Noelle S. Liao, Jonathan Bryan, Eunice A. Hankinson, Emily Castellanos
Abstract Number for Publication: e16039

(Press release, Flatiron Health, MAY 21, 2026, View Source [SID1234665970])

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])