On May 29, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 patients, underscoring consistent effectiveness and safety in clinical practice. Additionally, BEQALZI (sonrotoclax), which was recently approved by the U.S. Food and Drug Administration, and its development in combination with BRUKINSA (ZS) highlight the potential for next-generation, time-limited treatment approaches in CLL.

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Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"CLL is a disease patients live with for years, and the real measure of a therapy is how it performs over the long arc of treatment. Our data at ASCO (Free ASCO Whitepaper) show that BRUKINSA continues to deliver sustained disease control, which can give physicians and patients confidence to stay the course. Additionally, robust, real-world analyses reinforce its role as a best-in-class BTK inhibitor, with data favoring BRUKINSA over other BTK inhibitors across several efficacy and safety endpoints. With BRUKINSA as the foundation, we are building a broad, differentiated hematology franchise designed to push the field further, including our ZS combination, which achieved deep responses and unprecedented rates of uMRD, and emerging approaches like our BTK degrader, tacabrutideg. Together, these foundational therapies reflect our commitment to redefining what patients should expect from therapy both today and in the future."

78-month SEQUOIA data highlight the long-term impact of first-line treatment choice in CLL (Poster Presentation: 544; June 1, 2026, 9:00 AM-12:00 PM CDT)
SEQUOIA now provides the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, enabling a deeper understanding of how treatment outcomes evolve over time. After a median follow-up of 84.01 months (range, 0.0-101.5), BRUKINSA continued to show benefit over bendamustine-rituximab (BR) in patients with treatment-naive CLL/SLL, with progression-free survival (PFS) outcomes that are unprecedented among BTK inhibitors. Key highlights include:

78-month PFS: 71.8% (95% CI, 65.3-77.3) for BRUKINSA vs. 31.0% (95% CI, 24.3-37.9) for BR
78-month COVID-adjusted PFS: 74.6% (95% CI, 68.1-79.9) for BRUKINSA vs. 31.4% (95% CI, 24.7-38.4) for BR
PFS for patients with unmutated IGHV: 70.4% (95% CI, 61.0-77.9) for BRUKINSA vs. 17.4% (95% CI, 9.6-27.1) for BR
PFS for patients with mutated IGHV: 81.8% (95% CI: 72.2-88.4) for BRUKINSA and 45.1% (95% CI: 34.4-55.2) for BR
78-month PFS2: 81.3% (95% CI, 75.6-85.8) for BRUKINSA vs. 74.4% (95% CI, 67.8-79.8) for BR
78-month COVID-adjusted PFS2: 84.7% (95% CI, 79.2-88.8) for BRUKINSA and 76.4% (95% CI, 69.9-81.7) for BR
Of the BRUKINSA-treated patients who progressed (26/241), half received subsequent therapy with BCL2 inhibitor-based salvage therapy and 69.2% had not progressed after more than 3 years of follow-up.
Time to next treatment (TTNT) favored BRUKINSA over BR (HR, 0.24; 95% CI, 0.16-0.35; P<.0001)
Safety: consistent with the results of prior BRUKINSA studies with no new safety signals.
PFS2 captures outcomes beyond first disease progression, measuring time to disease progression on subsequent therapy or death. In CLL, this endpoint provides important insight into how first-line treatment impacts long-term disease control across multiple lines of therapy.

Constantine Tam, M.B.B.S., M.D., Head of Lymphoma Service at Alfred Health and Professor of Haematology at Monash University, said:
"In an indolent disease like CLL, many patients value maintaining disease control over the course of their life, not just in the first year or two of treatment. The continued long-term follow-up from SEQUOIA shows that zanubrutinib can deliver sustained disease control. This is the kind of evidence that allows clinicians and patients to make first-line decisions with real confidence about what lies ahead."

Real-world efficacy and safety data consistently underscore foundational BRUKINSA as the best-in-class BTKi for TN CLL (Poster Presentations: 545, 543 and 540; June 1, 2026, 9:00 AM-12:00 PM CDT)
In addition to the update from SEQUOIA, BeOne will present data from new analyses of large and robust datasets, which demonstrate consistent and significant real-world benefits of using BRUKINSA over other BTK inhibitors. Key highlights include:

In a real-world analysis of 10,523 Medicare patients, who were diagnosed with CLL/SLL and received frontline treatment with a BTK inhibitor, patients treated with BRUKINSA had a statistically significantly lower risk of death, advancing to next line, or discontinuing treatment, than those on ibrutinib or acalabrutinib. Similar results were observed across age subgroups. (Poster Presentation: 545)
In a separate real-world analysis of Komodo database claims from 16,788 patients with treatment-naïve CLL, BRUKINSA had a longer TTNT (unadjusted HR, 0.88; 95% CI, 0.79-0.97; P=.009) and overall survival (OS; HR, 0.72; 95% CI, 0.62-0.82; P<.001). (Poster Presentation: 543)
A retrospective analysis of 233,362 newly diagnosed CLL patients who initiated treatment with a BTK inhibitor, the atrial fibrillation rate within 1 year was lowest for BRUKINSA at 11% and 13% for acalabrutinib and 16% for ibrutinib (overall P<.0001). (Poster Presentation: 540)
Deep, rapid responses with BRUKINSA plus sonrotoclax (ZS) point to the future of time-limited treatment in CLL, including high-risk disease (Poster Presentation: 541; June 1, 2026, 9:00 AM-12:00 PM CDT)
In the Phase 1/1b study in patients with treatment-naïve CLL/SLL (median follow-up of ~34 months), the all-oral combination of BRUKINSA and next-generation BCL2 inhibitor sonrotoclax (ZS) demonstrated unprecedented rates and kinetics of undetectable minimal residual disease (uMRD), including in patients with high-risk cytogenetics. Key highlights include:

Overall response rate (ORR): 100%, with complete responses in 59.5% of patients
Best uMRD4 rate 98.8%
No patient that achieved uMRD4 reverted to uMRD positivity.
Best uMRD in patients with TP53 mutation/del(17p): 92.9% across 2 dose levels
Median time from combination start to uMRD4: 4.5 months
No disease progression events observed at the recommended Phase 2 dose of 320mg, including patients who electively discontinued therapy
Safety: consistent with previously reported BRUKINSA and sonrotoclax combination studies.
These data will also be presented as encore presentations at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 11–14, Stockholm) along with more than 30 other data sets from BeOne.

About BRUKINSA (zanubrutinib)
BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.

The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.

About BEQALZI (sonrotoclax)
BEQALZI (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,500 patients have been enrolled across the broad sonrotoclax global development program.

BEQALZI is approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a BTK inhibitor. It is also approved in China for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor.

About Tacabrutideg (BGB-16673)
Tacabrutideg is a foundational and potential first-in-class and best-in-class orally available Bruton’s tyrosine kinase (BTK) degrader. With 1,200+ patients dosed to date in an extensive global clinical development program, tacabrutideg is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, tacabrutideg is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease.

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tacabrutideg for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted tacabrutideg PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

Select Important Safety Information for BRUKINSA
Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).

In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Please see full U.S. Prescribing Information including U.S. Patient Information.

Select Important Safety Information for BEQALZI (sonrotoclax)
Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome.

In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%).

Please see full Prescribing Information.

The information provided in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, MAY 29, 2026, View Source [SID1234666234])

On May 29, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) trial, led by University College London (UCL). The results, which will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, conclude that the Prosigna Breast Risk of Recurrence (ROR) test safely guides adjuvant chemotherapy decisions in patients with early-stage, ER-positive HER2-negative breast cancer.

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"Behind every breast cancer treatment decision is a patient asking, ‘Do I really need chemotherapy?’" said Prof. Robert Stein, Lead Investigator, University College London. "OPTIMA answers this question with robust evidence. These study results can be practice-changing – we can now use the Prosigna test to predict which high-risk patients can safely avoid chemotherapy and its lasting side effects without compromising outcomes. That is a profound shift for patients and the clinicians who care for them."

The Phase III prospective, randomized controlled trial compared standard of care – chemotherapy followed by hormone therapy – to treatment guided by Prosigna test results: patients with high ROR scores (>60) received chemotherapy followed by hormone therapy while those with low ROR scores (≤60) received hormone therapy alone.

Key Trial Findings

The OPTIMA trial results demonstrate:

Chemotherapy can be safely avoided for many patients: The Prosigna test identified that 68% of patients with clinically high-risk node-positive breast cancer, who previously would have received chemotherapy, could safely forgo it entirely. These patients achieved 5-year cancer-free survival rates of 93.7% — statistically noninferior to the 94.9% achieved with chemotherapy — demonstrating that omitting treatment for these patients does not compromise outcomes or increase recurrence risk.
Robust results across broadest range of high-risk subgroups: Non-inferiority was confirmed in previously under-studied populations where treatment guidance has been most uncertain, demonstrating that tumor biology, vs clinical factors alone, can guide chemotherapy decisions for:
Premenopausal women treated with ovarian function suppression (HR 1.04; 90% CI 0.60–1.80)
Patients with extensive nodal involvement (4–9 positive nodes, or pN2 disease) (HR 1.19; 95% CI 0.62–2.29)
Highest level of prospective evidence: With 4,429 patients and 4.0-year median follow-up, OPTIMA provides Level 1A evidence, showing that the Prosigna test can accurately predict chemotherapy benefit and guide safe de-escalation across patient populations.
The Impact on Patients with Breast Cancer

Breast cancer remains the most commonly diagnosed cancer worldwide, affecting 1 in 8 women in the U.S.,1 with over 225,000 new HR+/HER2- breast cancer cases diagnosed annually.2 Treatment decisions play a critical role in preventing recurrence and improving long-term outcomes.

For many of these patients, chemotherapy decisions have historically been driven by clinical factors alone – age, tumor size, and lymph node status – and its potential for multiple, severe side effects. Up to 43% of breast cancer survivors experience persistent nerve damage years after chemotherapy, with studies showing a broader range of treatment-related side effects impacting the majority of patients during and after care.3

The Prosigna test is a genomic test that uniquely combines intrinsic subtypes and proliferation score with clinical pathological factors to calculate a patient’s Risk of Recurrence (ROR) score. In OPTIMA, an ROR score < 60 enabled clinicians to identify patients who could safely avoid chemotherapy. The results from the OPTIMA trial are in a position to transform how clinicians approach breast cancer treatment decisions using the Prosigna ROR score to confidently de-escalate therapy in a high percentage of high-risk patients.

"OPTIMA sets a new standard for how chemotherapy decisions are made in breast cancer," said Phillip Febbo, M.D., Chief Scientific and Medical Officer, Veracyte. "Prosigna now has the strongest prospective evidence of any genomic test to predict which patients with clinically high-risk hormone-receptor positive breast cancer can safely avoid chemotherapy. For patients, that means the option to choose a treatment with fewer unnecessary side effects, and for clinicians, the confidence to act on it."

ASCO Annual Meeting Presentation

The OPTIMA trial results are being presented this Saturday, May 30 at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting during the Breast Cancer—Local/Regional/Adjuvant Oral Abstract Session (1:15 PM CDT, Hall B1, Abstract 500). Prof. Robert C. Stein from University College London is presenting the findings, which will also be livestreamed via the ASCO (Free ASCO Whitepaper) conference platform.

About the OPTIMA Trial

OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) is an international, multicenter randomized controlled trial led by University College London and funded by U.K. National Institute for Health and Care Research. The independent study enrolled 4,429 women and men aged ≥40 years with ER-positive HER2-negative early breast cancer and 0–9 involved axillary lymph nodes. Participants were randomly assigned to either the control arm for standard chemotherapy followed by hormone therapy or to the Prosigna test-directed arm of standard chemotherapy followed by hormone therapy for patients with Prosigna high ROR test results (>60), versus hormone therapy alone for patients with Prosigna low ROR test results (≤60). All premenopausal women were required to have ovarian function suppression.

(Press release, Veracyte, MAY 29, 2026, View Source [SID1234666204])

On May 29, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that it will present data on CTA313, its investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy for Systemic Lupus Erythematosus (SLE), at the European Alliance of Associations for Rheumatology 2026 Congress (EULAR) in London from June 3-6, 2026. Additionally, the company will showcase data on CTD402, its allogeneic CAR-T cell therapy candidate being developed for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL), at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (EHA) (Free EHA Whitepaper) in Stockholm from June 11-14, 2026.

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EULAR 2026 publication details:

CTA313, CD19/BCMA Dual Targeted Allo-CAR-TANS Cell, Durable Remission in Systemic Lupus Erythematosus following Deep B-Cell Depletion, Suggestive of Immune-Reset

Abstract: AB1118

Abstracts are currently available to the public at: View Source

EHA2026 presentation details:

CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL

Abstract: EHA (Free EHA Whitepaper)-3404 Short: PS2331
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Session Type: Poster Session
Date & Time: Saturday, June 13, 18:45 CEST
Speaker: Dr. Xian Zhang, Hebei Yanda Ludaopei Hospital

TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL)

Abstract: EHA (Free EHA Whitepaper)-2777 Short: PS2350
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Session Type: Poster Presentation
Date & Time: Saturday, June 13, 18:45 CEST
Speaker: Dr. Lori Muffly, Professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Medicine, Palo Alto

Abstracts are currently available to the public at: View Source!*menu=6*browseby=3*sortby=2*ce_id=2934.

"These presentations at EULAR and EHA (Free EHA Whitepaper) underscore the transformative potential of our ANSWER platform to deliver readily available, off-the-shelf CAR-T therapies for patients with serious autoimmune diseases and hematologic malignancies," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. "We’re encouraged by the progress we’re making toward our goal of bringing innovative treatments to patients in need and look forward to continuing to advance our pipeline and mission."

For more information, visit www.imvivabio.com.

About CTA313

CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva’s proprietary ANSWER inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, MAY 29, 2026, View Source [SID1234666235])

On May 28, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Jefferies Global Healthcare Conference being held in New York, NY, from June 2-4, 2026.

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Jefferies Global Healthcare Conference Details
Format: Fireside Chat
Date: Thursday, June 4, 2026
Time: 12:50 PM ET
Webcast: Click Here

Management will also be available for one-on-one investor meetings during the conference. Please contact your Jefferies representative to schedule a meeting.

The webcast can also be accessed on the Events page of the Investors section of the Relmada website at View Source An archived replay will be available for 90 days following the conclusion of the event.

(Press release, Relmada Therapeutics, MAY 28, 2026, View Source [SID1234666152])

On May 28, 2026 BostonGene, developer of the leading AI model for tumor and immune biology, reported that nine abstracts have been accepted at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), scheduled to take place May 30 – June 2, 2026, at McCormick Place Convention Center in Chicago, IL. BostonGene will also exhibit at booth #33137.

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The accepted abstracts underscore the broad clinical utility of BostonGene’s AI-powered models and advanced analytical platforms, including the Tumor Portrait test and Kassandra cell deconvolution. Spanning both tissue and peripheral blood analysis, the featured research showcases how integrating deep genomic, transcriptomic, and immunomic profiling can identify novel actionable biomarkers, predict immunotherapy response and toxicity, and map complex resistance mechanisms. Developed in collaboration with leading institutions such as the UT MD Anderson Cancer Center, Weill Cornell Medicine, and the Parker Institute for Cancer Immunotherapy, these studies highlight BostonGene’s pivotal role in accelerating biomarker discovery and optimizing patient stratification for clinical trials.

Details about the abstracts selected for presentation can be found below:

Poster presentations
Poster number: 273
Title: TROP2 as an actionable biomarker for anal cancer
Date & time: May 30 | 9:00 AM – 12:00 PM
Speaker: Mir Lim, MD, UT MD Anderson

BostonGene and MD Anderson Cancer Center collaborated to perform comprehensive genomic profiling of localized and metastatic anal cancers, assessing TACSTD2 (TROP2) expression as a potential therapeutic biomarker. The analysis found high TACSTD2 expression that correlated with TROP2 immunohistochemistry, supporting its potential use in identifying patients who may benefit from anti-TROP2 antibody-drug conjugates. The study underscores the clinical utility of BostonGene’s Tumor Portrait test in biomarker discovery and validation.

Research conducted in collaboration with UT MD Anderson

Poster number: 257
Title: Developing harmonized tumor microenvironment subtypes for patient stratification in clinical trials
Date & time: May 30 | 1:30 PM – 4:30 PM
Speaker: Sofya Kust, PhD, BostonGene

BostonGene developed an AI-driven harmonized tumor microenvironment (HTME) classification system to improve patient stratification for immunotherapy and targeted therapies across solid tumors. By applying machine learning approaches—including agglomerative clustering, K-nearest neighbors classification, and transcriptomic pathway analysis—to RNA-seq data from more than 40,000 cancer samples, the study identified nine reproducible TME subtypes capturing key biological features such as immune activity, fibrosis, vascularization, and hypoxia. The AI-based framework outperformed existing methods by integrating multiple biological dimensions simultaneously and accurately predicting treatment response and progression-free survival across different cancer types and therapies.

Poster number: 323
Title: Multimodal immunoprofiling of peripheral blood using foundation models of the immune system for predicting immunotherapy response and toxicity in the RADIOHEAD pan-cancer cohort
Date & time: May 30 | 1:30 PM – 4:30 PM
Speaker: Evgeny Barykin, PhD, BostonGene

In collaboration with Parker Institute for Cancer Immunotherapy, BostonGene applied AI-based models of the immune system to analyze blood samples from more than 1,000 cancer patients receiving immune checkpoint inhibitor (ICI) therapy in the RADIOHEAD pan-cancer cohort. By combining RNA sequencing, flow cytometry, and machine learning models trained on 45,000 patient profiles, the study identified immune signatures linked to both treatment response and severe immune-related toxicities. The AI-driven embeddings and multimodal immunoprofiling approach successfully stratified patients into responder, non-responder, and high-risk toxicity groups, highlighting the potential of AI-powered peripheral blood profiling to improve immunotherapy patient selection.

Research conducted in collaboration with Parker Institute for Cancer Immunotherapy

Poster number: 360
Title: Effects of a multimodal TCR/BCR repertoire foundation model on blood RNA-seq–based prediction of severe adverse event risk and rheumatoid arthritis
Date & time: May 30 | 1:30 PM – 4:30 PM
Speaker: Alexander Bagaev, PhD, BostonGene

BostonGene utilized its immune model leveraging multimodal TCR/BCR repertoire data to address two critical clinical challenges: predicting severe immune-related adverse events (irAEs) in cancer patients receiving immune checkpoint inhibitors and detecting rheumatoid arthritis from peripheral blood. By integrating adaptive immune receptor repertoire embeddings with gene expression signatures, the model significantly outperformed traditional immune repertoire analysis approaches—such as clonality, diversity, and V(D)J gene usage metrics—in both predictive accuracy and cross-cohort robustness. These advances enabled earlier risk stratification and more precise immunotherapy management than conventional biomarker methods.

Poster number: 533
Title: Immune priming with the EZH2 inhibitor tazemetostat in B-cell lymphomas receiving CART cell therapy
Date & time: June 1 | 9:00 AM – 12:00 PM
Speaker: Samuel Yamshon, MD, Weill Cornell Medicine

BostonGene applied its multimodal molecular profiling platform to characterize the systemic immune remodeling driven by tazemetostat priming in patients with B-cell lymphomas receiving CART therapy. By integrating high-parameter flow cytometry, RNA sequencing, immune cell deconvolution, and functional gene signature analysis, BostonGene’s analysis revealed systemic immune remodeling associated with enhanced antigen presentation, T-cell activation, and reduced immunosuppressive signaling—supporting the use of EZH2 inhibition for improved CART efficacy and durability.

Research conducted in collaboration with Weill Cornell Medicine

Poster number: 268b
Title: IvoLoC: A phase II trial of ivonescimab (IVO) in endocrine-refractory hormone receptor (HR)-positive or triple-negative (TN) metastatic invasive lobular carcinoma (mILC)
Date & time: June 1 | 1:30 PM – 4:30 PM
Speaker: Jason Mouabbi, MD, UT MD Anderson

In a trial in progress with UT MD Anderson Cancer Center, BostonGene will perform multimodal longitudinal blood and tissue analysis for mILC patients receiving the bispecific antibody targeting PD-1 and VEGF, ivonescimab. Moving beyond traditional efficacy metrics, complex correlates linking clinical outcomes with molecular features are ongoing. By integrating real-time ctDNA dynamics with predictive responder scores, BostonGene aims to identify critical markers of response and resistance needed to optimize treatment durability and refine future trial strategies.

Research conducted in collaboration with UT MD Anderson

Online only
Abstract number: e12594
Title: Examining the tumor microbiology and microenvironment of patients with triple negative inflammatory breast cancer receiving Keynote 522

Stage III triple‑negative inflammatory breast cancer patients receiving KN522 therapy were analyzed with BostonGene’s integrative multimodal platform. By combining intrinsic subtype classification with immune deconvolution, BostonGene successfully mapped the molecular landscape of treatment response. Non-responders were marked by angiogenic and endothelial remodeling and potential biomarkers of brain metastasis risk, demonstrating the platform’s unique capability to predict both therapeutic outcomes and disease progression.

Research conducted in collaboration with UT MD Anderson

Abstract number: e13080
Title: Real-world clinical utility of comprehensive genomic and transcriptomic profiling in metastatic breast cancer (mBC)
Description: Clinicians at MD Anderson Cancer Center utilized BostonGene’s Tumor Portrait test to validate the impact of comprehensive genomic profiling in guiding treatment decisions and predicting outcomes in a heterogeneous real-world mBC cohort. The findings demonstrated that BostonGene’s integrated approach uncovered clinically actionable insights and predictive signatures that directly guided treatment selection and improved patient outcomes.

Research conducted in collaboration with UT MD Anderson

Abstract number: e16004
Title: Association of angiogenic, fibrotic, and immunosuppressive tumor microenvironment with immunotherapy outcomes in metabolic disease–associated biliary tract cancers

Researchers at MD Anderson Cancer Center leveraged BostonGene’s transcriptomic classifiers and KassandraTM cell deconvolution to characterize the tumor microenvironment (TME) of metabolic disease-associated biliary tract cancers. The analysis uncovered a distinct TME in metabolic disease-associated cholangiocarcinoma that likely impairs response to immune checkpoint inhibitors, demonstrating the value of BostonGene’s AI-powered solutions for therapeutic response prediction and trial design.

Research conducted in collaboration with UT MD Anderson

For more information, please visit the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

(Press release, BostonGene, MAY 28, 2026, View Source [SID1234666168])