A2 Biotherapeutics Presents Safety and Efficacy Data from the EVEREST-2 Clinical Study, Including Update on the First Complete Response to CAR T-Cell Therapy in a Patient with Non-Small Cell Lung Cancer

On May 21, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported the presentation of safety and efficacy data from the ongoing EVEREST-2 clinical study (NCT06051695). The findings, which are being presented in poster presentations during the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 29 – June 2, 2026, in Chicago, include updates on the first reported complete response (CR) in a patient with non-small cell lung cancer (NSCLC) following treatment with A2B694, a logic-gated mesothelin (MSLN)-targeted TmodTM chimeric antigen receptor T-cell (CAR T-cell) therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors, and to date none has been reported in patients with lung cancer.1

"We are encouraged by the EVEREST-2 study data being presented during ASCO (Free ASCO Whitepaper) 2026, including updated results for the first reported complete response to CAR T-cell therapy in a patient with a hard-to-treat case of non-small cell lung cancer. These findings support the potential for logic-gated therapies, such as A2B694, to treat solid tumors. We eagerly await the results from A2B543, the armored version of A2B694, which has the potential for greater potency without compromising safety," said Salman R. Punekar, M.D., assistant professor of medicine, NYU Langone Health, Perlmutter Cancer Center and treating physician of the patient.

EVEREST-2 Study Arm 1: Efficacy and Safety Update for A2B694

As of January 5, 2026, 13 patients were enrolled in phase 1: eight women and five men, with a median age of 59 years; 11 were non-Hispanic White and two were Hispanic/unknown race. Tumor types included ovarian (n = 3), pancreatic (n = 3), NSCLC (n = 1), colorectal (n = 4), gastro-esophageal (n = 1), and mesothelioma (n = 1). A2B694 dose groups were 1×108 (n = 3), 2×108 (n = 4), 4×108 (n = 5), and 6×108 plus low-dose IL-2 (n = 1) cells.

Lymphodepletion prior to administration of A2B694 was well-tolerated by all patients, with expected transient cytopenias. All patients had at least one adverse event; all adverse event terms were reported in one patient each, except for grade 3 neutropenia, which was reported in two patients. One patient had grade 3 ICANS managed with corticosteroids and one patient had grade 1 CRS confounded by IL-2 administration. There were no dose-limiting toxicities or new safety signals after up to 17 months of follow-up. No deaths were attributed to A2B694, and no patient has discontinued the study due to adverse events.

One patient with co-mutated (KRAS G12V/STK11) NSCLC, a subtype associated with resistance to chemoimmunotherapy and poor prognosis, had progressed on standard-of-care first-line treatment of carboplatin, pemetrexed, and pembrolizumab before enrolling in EVEREST-2. At month 3 post-infusion of A2B694, the patient achieved a complete response (CR) per RECIST 1.1 and had a confirmed CR by central review at month 6 as well as a PET-CT scan which showed no evidence of disease. At month 8, the patient had an isolated CNS relapse, with an ongoing non-CNS CR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) at month 9. At 15 months, the patient’s CT showed no new findings, and persistence of A2B694 in the blood was confirmed by ddPCR.

EVEREST-2 Study Arm 2: Enrollment Update on A2B543

An additional presentation from the EVEREST-2 study is a trials-in-progress poster about A2B543, a CAR T-cell therapy which uses the same logic-gated construct as A2B694, armored with the addition of a membrane-tethered IL-12 (mem-IL-12) booster.

IL-12 is a potent, pro-inflammatory cytokine that plays a crucial role in inducing antitumor immune responses; however, systemic IL-12 can be prohibitively toxic. In A2B543, expression of the mem-IL-12 cassette is under the control of an NFAT promoter and is induced during antigen engagement or T cell activation. This inducible mem-IL-12 is designed to reduce the toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of TmodTM. The first A2B543 patient was enrolled to dose level 1 in January 2026, and dose escalation continues. A2B543 has received Fast Track Designation from the FDA.

A third A2 Bio poster presentation during ASCO (Free ASCO Whitepaper) 2026 describes modules based on IL-12 and other molecules that boost potency and preserve selectivity of TmodTM-based precision cell therapies.

Poster Presentation Details

Abstract Title

Presenting Author

Abstract Number

Poster Board Number

Poster Presentation Date/Time

Poster Session

Initial safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)-targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH)

Julian R. Molina, M.D., Ph.D.

Mayo Clinic
Rochester, Minn.

8579

369

Sunday, May 31, 2026

9:00 AM-12:00 PM CDT

Lung Cancer—Non- Small Cell Metastatic

A logic-gated chimeric antigen receptor T-cell (CAR T) therapy with an armored, membrane-tethered IL-12 booster in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH): EVEREST-2, a Phase 1/2 study

Salman R. Punekar, M.D.

NYU Langone Health
New York

TPS2673

459a

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

Influence of onboard, tethered IL-12 on potency of the Tmod NOT gate and selectivity

Jushen Liang

A2 Biotherapeutics
Agoura Hills, Calif.

2562

352

Saturday, May 30, 2026

1:30 PM-4:30 PM CDT

Developmental Therapeutics— Immunotherapy

Full abstracts are available online on the ASCO (Free ASCO Whitepaper) website.

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is recruiting patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

Invented at A2 Bio, the TmodTM platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

(Press release, A2 Biotherapeutics, MAY 21, 2026, View Source [SID1234665974])

City of Hope Researchers Present Advances in Targeted Therapies, Microbiome Science and Blood Cancers at ASCO 2026

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRC

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

858 Therapeutics Announces Initial Data from First-in-Human Phase 1/2 Trial of PARG Inhibitor ETX-19477 to be Presented at 2026 ASCO Annual Meeting

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

Flatiron Health Brings 25+ Research Acceptances and Next-Generation Capabilities to ASCO 2026

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])