Novartis advances RLT innovation and reinforces leadership in prostate cancer, breast cancer and hematology with new data at ASCO and EHA

On May 21, 2026 Novartis reported it will present data from more than 65 company or investigator sponsored abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress.

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!

"We are excited about sharing our latest advancements in radioligand therapy with new Pluvicto data and early insights from our actinium-based RLT," said Mark Rutstein, MD, Global Head, Oncology Development, Novartis. "With a legacy of bold science, our Kisqali and Scemblix data offer continued evidence of how we meaningfully move cancer treatment forward for patients."

Key ASCO (Free ASCO Whitepaper) data highlights include:

Abstract Title Abstract Number/
Presentation Details
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

Subgroup Analyses by Disease Volume and De Novo/Recurrent mHSPC in the PSMAddition Study of [177Lu]Lu-PSMA-617

225Ac-PSMA-617
AcTION: Phase 1 Study of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in Men With Metastatic Castration-resistant Prostate Cancer (mCRPC) With or Without Prior [177Lu]Lu-PSMA (177Lu-PSMA) Radioligand Therapy (RLT) Abstract # 5020
Rapid Oral
May 31, 4:30pm – 6:00pm CDT

Abstract # 5010
Oral
June 1, 3:00pm – 4:30pm CDT

Scemblix (asciminib)

ASC4FIRST wk 144 Analysis: Efficacy and Safety and Tolerability With Asciminib (ASC) vs Investigator-Selected Tyrosine Kinase Inhibitors (IS TKIs) in Newly Diagnosed (ND) chronic myeloid leukemia in Chronic Phase (CML-CP)

Abstract #6583
Poster
June 1, 9:00am – 12:00pm CDT
Kisqali (ribociclib)

Prognostic and Predictive Impact of Baseline Gene Expression (Exp) in the NATALEE Trial of Adjuvant (Adj) Ribociclib (RIB) + Nonsteroidal Aromatase Inhibitor (NSAI) in HR+/HER2− Early Breast Cancer (EBC)

Abstract #501
Oral
May 30, 1:15pm – 4:15pm CDT
Real-World (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 (Pts) With Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2–) Metastatic Breast Cancer (MBC) in the US

Abstract #1073
Poster
June 1, 1:30pm – 4:30pm CDT

Real-World (RW) Post-Progression Outcomes After First-Line (1L) Treatment With Ribociclib + an Aromatase Inhibitor (AI) vs AI Alone in US Patients With Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2–) Metastatic Breast Cancer (MBC) Abstract # e13044
Online publication

Key EHA (Free EHA Whitepaper) data highlights include: 

Abstract Title Abstract Number/ Presentation Details
Scemblix (asciminib)

ASC4FIRST wk 144 Analysis: Continued Superior Efficacy and Favorable Safety of Asciminib vs Investigator-Selected Tyrosine Kinase Inhibitors in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Abstract # S160
Oral
June 11, 4:45pm – 6:00pm CEST
Ianalumab (VAY736)
Effect of Ianalumab Plus Eltrombopag on Patient-Reported Outcomes in Primary Immune Thrombocytopenia: Results From the VAYHIT2 Phase 3 Trial

Abstract # PF1340
Poster
June 12, 6:45pm – 7:45pm CEST
Pelabresib (DAK539)
Pelabresib Monotherapy in Myelofibrosis After Janus Kinase Inhibitor Failure: Results From Arm 1 of the Open-Label, Phase 2 MANIFEST Study

Abstract # PS1987
Poster
June 13, 6:45pm – 7:45pm CEST
Rapcabtagene autoleucel (YTB323)
Safety, Cellular Kinetics and Early Efficacy of Rapcabtagene Autoleucel (YTB323), a Rapidly Manufactured Autologous CD19 CAR-T Therapy, in Severe, Refractory Autoimmune Diseases

Abstract # PF1241
Poster
June 12, 6:45pm – 7:45pm CEST
Fabhalta (iptacopan)
Iptacopan demonstrates sustained efficacy and safety in paroxysmal nocturnal hemoglobinuria: up to 4 years of follow-up in patients from APPLY, APPOINT and roll-over extension program

Abstract #PS1788
Poster
June 13, 6:45pm – 7:45pm
CEST

Long-term hematologic control and safety in patients with paroxysmal nocturnal hemoglobinuria treated with iptacopan: 6-year follow-up from phase 2 studies and roll-over extension program Abstract # PS1797
Poster
June 13, 6:45pm – 7:45pm
CEST

(Press release, Novartis, MAY 21, 2026, View Source [SID1234665899])

Aulos Bioscience Reports Positive Phase 2 Data for Imneskibart in Doublet Checkpoint Inhibitor-Refractory Metastatic Melanoma at 2026 ASCO Annual Meeting

On May 21, 2026 Aulos Bioscience, a clinical-stage immuno-oncology company developing an immune-activating antibody therapeutic designed by leveraging an AI platform, reported positive Phase 2 data from its ongoing Phase 1/2 study of imneskibart in patients with doublet checkpoint inhibitor (CPI)-refractory metastatic melanoma. The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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 Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. Patients received either imneskibart plus low-dose, subcutaneous aldesleukin or the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab. Across the study, imneskibart treatment was associated with sustained regulatory T cell (Treg) reduction, increased CD8/Treg ratios and evidence of durable anti-tumor activity, supporting its differentiated IL-2 mechanism.

"Imneskibart’s triplet regimen produced a 33% objective response rate and 67% disease control rate in metastatic melanoma patients whose disease progressed following earlier treatment with potent checkpoint inhibitor doublets," said Aron Knickerbocker, Aulos Bioscience’s President and Chief Executive Officer. "These patients urgently need safe, life-extending treatment options, particularly those who are not eligible for or do not receive TIL therapy. While lifileucel TIL therapy is the only FDA-approved product specifically indicated in the post-PD-1 setting, a substantial treatment gap remains. In addition to durable efficacy consistent with anti-tumor immune memory formation, imneskibart continues to demonstrate a differentiated, potentially best-in-class safety profile. These findings strongly support imneskibart’s mechanism and its ability to make a meaningful difference for patients."

As of the April 6, 2026 data cutoff, data were available from 83 patients across the Phase 1/2 study, including 12 patients in the Phase 2 melanoma triplet cohort evaluable for response:

Clinically meaningful activity observed with imneskibart triplet in doublet CPI-refractory melanoma

33% objective response rate (ORR) in confirmed doublet CPI-refractory cutaneous melanoma patients following prior anti-PD-1/CTLA-4 or anti-PD-1/LAG-3 therapy.
Four of 12 patients achieved partial responses, with target tumor reductions of 52%, 65%, 74% and 77%.
Four of 12 patients achieved stable disease, resulting in a 67% disease control rate.
Responses are ongoing and deepening, consistent with the potential generation of de novo anti-tumor immunity and immune memory formation; progression-free survival (PFS) and overall survival (OS) data continue to mature.
Strong signal of anti-tumor activity in imneskibart doublet regimen, with ongoing deep and durable tumor reductions in patients who progressed after receiving doublet CPI therapy (prior anti-PD-1 and anti-CTLA-4 and/or anti-PD-1 and anti-LAG-3)

14 evaluable patients received the imneskibart doublet regimen.
Three patients with the deepest target tumor reductions continued treatment beyond one year: one patient with a 48% tumor reduction continued on treatment for 13 months; another patient with a 58% reduction in measurable non-target tumors continued on treatment for 18.5 months; and a third patient with a complete response (100% reduction) in the target lesions continues on treatment for more than 25 months.
Imneskibart and low-dose, subcutaneous aldesleukin, with or without nivolumab, exhibits unique pharmacodynamic (PD), biological and pharmacokinetic (PK) effects in the IL-2 class, with a higher peripheral blood CD8/Treg ratio correlating with increased survival

Durable increases in CD8+ T cells and CD8/Treg ratios were observed in patients, with a corresponding decrease in Tregs.
PD data support hypothesis of selective effector cell expansion, validating imneskibart’s mechanism of action of redirecting interleukin-2 (IL-2) away from trimeric IL-2 receptors (expressed on Tregs and vasculature) and toward dimeric IL-2 receptors (on CD8+ T effector and natural killer cells).
The data show that imneskibart demonstrates durable activity coupled with a persistent reduction in Tregs and a higher CD8/Treg ratio that is associated with longer OS, PFS and time on treatment for patients.
PK data demonstrate sustained, selective signaling with a half-life of greater than 19 days, enabling potent immune activation without Treg expansion or high-dose IL-2 toxicities such as vascular leak syndrome or pulmonary edema.
Well-tolerated triplet regimen, with no apparent increase in Grade 3/4 adverse events following addition of nivolumab

Most drug-related adverse events were Grade 1 or 2; no patient discontinued treatment due to a drug-related adverse event.
The emerging safety profile of the triplet regimen is consistent with the known safety profiles of nivolumab and imneskibart plus aldesleukin, with no new toxicity signals observed.
Enrollment is complete in the Phase 2 doublet cohort evaluating imneskibart plus a single loading dose of low-dose, subcutaneous aldesleukin in patients with unresectable locally advanced or metastatic cutaneous melanoma following confirmed progression on doublet CPI therapy. Enrollment continues in the Phase 2 triplet cohort evaluating imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab in approximately 20 evaluable second-line cutaneous melanoma patients, with plans advancing toward potential registrational development.

Two ongoing Phase 2 cohorts are evaluating imneskibart and low-dose, subcutaneous aldesleukin administered without and with avelumab (anti-PD-L1 with an active Fc domain and ADCC effector function) in patients with advanced PD-L1+ non-small cell lung cancer (NSCLC) that progressed on prior CPI therapy (with or without chemotherapy). Aulos anticipates presenting comprehensive clinical data from the NSCLC Phase 2 cohorts by year-end.

The poster, "Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study," (Abstract 9526) will be presented live in the poster session "Melanoma/Skin Cancers" in the Exhibit Hall at McCormick Place on Sunday, May 31, 2026, 9:00 a.m. to 12:00 p.m. CDT. The poster will also be accessible to meeting registrants as an electronic poster on the ASCO (Free ASCO Whitepaper) online meeting platform.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

(Press release, Aulos Bioscience, MAY 21, 2026, View Source [SID1234665916])

Moleculin Highlights Abstract Accepted for Poster Presentation at the 2026 ASCO Annual Meeting Highlighting Cardiac Safety Data for Annamycin

On May 21, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that an abstract featuring pooled cardiac safety data for its lead drug candidate Annamycin (also known as "L-Annamycin" or "naxtarubicin"), has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. Access the abstract here.

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 abstract, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," will be presented in a poster session focused on Symptom Science and Palliative Care.

Presentation Details:

Session Type: Poster Session – Symptom Science and Palliative Care
Presentation Date and Time: May 30, 2026, 1:30 PM – 4:30 PM CDT
Location: Poster Board #8
The abstract presents pooled cardiac safety analyses from sponsor- and investigator-initiated clinical trials evaluating Annamycin (also known as "L-Annamycin" or "naxtarubicin") in patients with acute myeloid leukemia (AML) and soft tissue sarcoma.

Key findings include:

Independent cardiac safety review conducted in 90 patients treated with L-Annamycin across five completed clinical trials
Source-verified pre-and-post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients
Median cumulative L-Annamycin dose of 660 mg/m2 (95% CI, 645-690; range, 210-2,970 mg/m2), with most cumulative doses exceeding conventional lifetime anthracycline limits
No statistically significant change in LVEF from baseline to final assessment (mean difference, -0.12%; 95% CI, -1.34 to 1.09; p = 0.84)
No correlation observed between cumulative L-Annamycin dose and change in LVEF (p = 0.12)
No correlation observed between patient age and change in LVEF (p = 0.73)
Independent review of serial ECGs, cardiac biomarkers, cardiac adverse events, and available global longitudinal strain measurements demonstrated no evidence of drug-induced cardiotoxicity
"Acceptance of these findings at ASCO (Free ASCO Whitepaper) highlights the growing body of evidence supporting the differentiated safety profile of Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "These data continue to support the potential for Annamycin to provide effective anthracycline therapy without the traditional cumulative dose limitations associated with cardiotoxicity. We believe these findings further strengthen the rationale for our ongoing pivotal Phase 2b/3 MIRACLE trial in AML patients."

Anthracyclines remain among the most widely used chemotherapy agents but are limited by cumulative dose-dependent cardiotoxicity. Annamycin is designed to avoid multidrug resistance mechanisms while potentially eliminating the cardiotoxicity commonly associated with currently prescribed anthracyclines.

Previously reported results from the Company’s Phase 1b/2 study evaluating Annamycin in combination with cytarabine as second-line therapy in AML demonstrated:

50% complete remission (CR) rate
60% composite complete remission (CRc) rate
Median overall survival of 12.39 months (95% CI, 2.07-13.96) in the intent-to-treat population
The ASCO (Free ASCO Whitepaper) Annual Meeting is one of the largest and most influential gatherings of oncology professionals worldwide, featuring cutting-edge research and advances in cancer treatment. For more information, please visit asco.org.

(Press release, Moleculin, MAY 21, 2026, View Source [SID1234665934])

BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts

On May 21, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that more than 60 abstracts across hematologic malignancies and solid tumors have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 29–June 2, Chicago) and the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 11–14, Stockholm).

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!

Continuing to raise the bar in CLL

At ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 2026, BeOne will showcase its hematology leadership with data spanning foundational therapies and next-generation innovation across CLL, mantle cell lymphoma and other B-cell malignancies. The data emphasize impressive long-term outcomes, durability across patient populations, and a disciplined approach to advancing future regimens. Collectively, these data underscore BeOne’s strategy to lead in hematology science and patient impact by setting the standard today – while helping to shape the future of CLL.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

"Seventy-eight-month follow-up data from SEQUOIA underscore what it truly takes to lead in CLL over the long term: long-term efficacy, ability for sequencing treatments, and confidence in first-line treatment decisions. Building on that leadership, we’re excited to be rapidly advancing the next generation of medicines, including sonrotoclax-based combinations and our BTK degrader BGB-16673, which are designed to extend what is possible for patients across lines of therapy."

Key data presentations in CLL include:

New results from the SEQUOIA trial with 78 months follow-up reinforce BRUKINSA (zanubrutinib) as the foundational BTK inhibitor in CLL, with durable disease control that continues to raise expectations for what patients and physicians should expect from first-line therapy over the long term. Data will be presented at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).
A subgroup analysis of SEQUOIA, which includes one of the largest and longest-followed cohorts of patients aged ≥80 years ever reported in a Phase 3 CLL study, showing that age did not limit benefit. Data will be presented at EHA (Free EHA Whitepaper) 2026.
Oral presentation at EHA (Free EHA Whitepaper) 2026 of updated data of BeOne’s foundational BTK degrader – BGB-16673 – in patients with R/R CLL, demonstrating promising and durable activity and a manageable safety profile. An additional poster will be shared featuring never-before-presented data of BGB-16673 in BTK-naïve patients. BGB-16673 is the most advanced BTK degrader in the clinic, with more than 1,100 patients dosed.
Data from the all-oral combination of BeOne’s foundational BCL2 inhibitor sonrotoclax plus zanubrutinib (ZS) in CLL, which demonstrated deep responses, unprecedented speed to undetectable MRD, and durable remissions and a generally well-tolerated safety profile. These data reinforce the potential for a next-generation, time-limited approach designed to deliver long-term outcomes without compromising durability or safety. Data will be presented as a poster at ASCO (Free ASCO Whitepaper) 2026 and an oral presentation at EHA (Free EHA Whitepaper) 2026.
Accelerating a high-potential solid tumor portfolio

BeOne is highlighting strong momentum across its deep and diverse solid tumor portfolio at ASCO (Free ASCO Whitepaper), with seven unique assets featured in three oral presentations and eight posters. These data span both in-line and pipeline therapies, including results demonstrating the differentiated profile of PD-1 inhibitor TEVIMBRA (tislelizumab) across lung and gastrointestinal cancers, as well as in combination with the novel HER2-targeting agent ZIIHERA (zanidatamab). The Company’s development superhighway is accelerating progress across all stages of development, generating compelling clinical data that support the potential of these therapies to reshape treatment in areas of high unmet need.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

"At ASCO (Free ASCO Whitepaper) 2026, we are demonstrating the strength of BeOne’s science, the scale of our pipeline, and the speed at which we are delivering innovation for patients. With multiple programs moving simultaneously toward pivotal trials, we are building durable disease leadership across breast, gynecologic, lung and gastrointestinal cancers – areas where substantial unmet patient need remains."

Key data presentations across our solid tumor programs include:

First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer.
Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data.
Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody, with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients.
Rapid oral presentation with a PD-L1 subgroup analysis of the HERIZON-GEA-01 trial in which TEVIMBRA in combination with ZIIHERA and chemotherapy demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with HER2+ gastroesophageal adenocarcinoma, irrespective of PD-L1 expression (in partnership with Jazz Pharmaceuticals).
Investor webcast to highlight pipeline data at ASCO (Free ASCO Whitepaper)

BeOne will host an investor webcast on June 1, 2026, at 7:00 PM CDT/8:00 PM EDT, led by John V. Oyler, Co-Founder, Chairman, and CEO, alongside the Company’s leadership team and invited key opinion leaders. The webcast will review clinical and corporate highlights from ASCO (Free ASCO Whitepaper), provide updates on BeOne’s global R&D pipeline and platforms, and discuss the strategic priorities and execution capabilities driving the Company’s long-term growth.

Webcast access details are available in the Investors section of BeOne’s website at View Source, View Source, and View Source An archived webcast will be available on the Company’s website.

Full list of BeOne’s presentations at ASCO (Free ASCO Whitepaper):

Hematology

BRUKINSA (Zanubrutinib)

Abstract Title

Presentation Details

Lead Author

Subsequent therapies and time to second progression-free survival events in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab in SEQUOIA

Poster Presentation: 544

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Constantine S. Tam

Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization

Poster Presentation: 556

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Alvaro Alencar

Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia

Poster Presentation: 545

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Daniel A. Ermann

Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia

Poster Presentation: 540

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Michael Fradley

Real-world treatment survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States

Poster Presentation: 543

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Ryan Jacobs

A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States

Poster Presentation: 560

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Yucai Wang

Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib

Abstract Number: e19020

Ryan Jacobs

Risk factors for second primary malignancies in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: A real-world study

Abstract Number: e19022

Lili Zhou

Characterizing patient self-reported adherence to BTKis and symptoms in CLL/SLL using an electronic patient-reported outcomes platform

Abstract Number: e19030

Mustafa Ascha

Real-world treatment utilization, sequencing patterns, and healthcare resource utilization in Waldenström macroglobulinemia

Abstract Number: e19056

Jorge Castillo

Sonrotoclax

Abstract Title

Presentation Details

Lead Author

First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53

Poster Presentation: 541

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Constantine S. Tam

Sonrotoclax + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2)

Poster Presentation: 596a

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Mazyar Shadman

Efficacy of sonrotoclax vs pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison

Abstract Number: e19050

Alvaro Alencar

Solid Tumors

BGB-43395 (CDK4i)

Abstract Title

Presentation Details

Lead Author

First disclosure of frontline treatment with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer: A phase 1 safety expansion

Poster Session: 180

Session Title: Poster Session – Breast Cancer – Metastatic

Session Date/Time: June 1, 2026, 1:30-4:30 PM CDT

Shom Goel

BG-C9074 (B7-H4-targeting ADC)

Abstract Title

Presentation Details

Lead Author

First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion

Rapid Oral Abstract: 3013

Session Title: Rapid Oral Abstract Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT

Binghe Xu

Consideration of adjusted ideal body weight dosing in BG-C9074 (B7-H4-targeting ADC) from pharmacokinetics, efficacy and safety perspectives

Poster Session: 166

Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT

Hugh Giovinazzo

BGB-B2033 (GPC3x4-1BB bispecific antibody)

Abstract Title

Presentation Details

Lead Author

A phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy in patients with selected advanced or metastatic solid tumors: First disclosure of clinical data

Rapid Oral Abstract: 3016

Session Title: Rapid Oral Abstract Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT

Hong Jae Chon

TEVIMBRA (tislelizumab) and ZIIHERA (zanidatamab)

Abstract Title

Presentation Details

Lead Author

Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: PD-L1 subgroup analysis from HERIZON-GEA-01

Rapid Oral Abstract: 4010

Session Title: Rapid Oral Abstract
Session – Gastrointestinal
Cancer-Gastroesophageal,
Pancreatic, and Hepatobiliary

Session Date/Time: June 1, 2026, 1:15-2:45 PM CDT

SunYoung Rha

Characterization and management of gastrointestinal adverse events with zanidatamab + chemotherapy ± tislelizumab in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: Analysis from HERIZON-GEA-01

Poster Presentation: 25

Session Title: Poster Session –

Gastrointestinal Cancer-

Gastroesophageal, Pancreatic,

and Hepatobiliary

Session Date/Time: May 30, 2026, 9
AM-12:00 PM CDT

Elena Elimova

TEVIMBRA (tislelizumab)

Abstract Title

Presentation Details

Lead Author

RATIONALE-315: Post hoc analysis of event-free survival by surgically relevant subgroups treated with perioperative tislelizumab and neoadjuvant chemotherapy vs neoadjuvant chemotherapy

Poster Presentation: 533

Session Title: Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session Date/Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Gustavo Schvartsman

Quality-adjusted survival comparison for tislelizumab + chemotherapy (CT) versus placebo + CT as first-line treatment in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis: Long-term follow-up from RATIONALE-305

Poster Presentation: 17

Session Title: Poster Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date/Time: May 30, 2026, 9:00 AM-12:00 PM CDT

Rutika Mehta

A novel Bayesian approach for assessing associations between ECOG performance status and patient-reported outcomes in patients with gastric or gastroesophageal junction adenocarcinoma: Post hoc analysis from the RATIONALE-305 trial

Abstract Number: e16044

Marcia Cruz-Correa

Ociperlimab

Abstract Title

Presentation Details

Lead Author

Exploratory biomarker analysis of ociperlimab plus tislelizumab in patients with PD-L1-positive non-small cell lung cancer in AdvanTIG-105

Poster Session: 361

Session Title: Poster Session – Developmental Therapeutics – Immunotherapy

Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT

Jun Zhang

BGB-A3055 (anti-CCR8)

Abstract Title

Presentation Details

Lead Author

A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti-PD-1) in patients with solid tumors

Poster Session: 313

Session Title: Poster Session – Developmental Therapeutics – Immunotherapy

Session Date/Time: May 30, 2026, 1:30 PM-4:30 PM CDT

Judith Raimbourg

Full list of BeOne’s presentations at EHA (Free EHA Whitepaper):

Zanubrutinib

Abstract Title

Presentation Details

Lead Author

Long-term follow-up for safety and efficacy of zanubrutinib in elderly (≥80 years) treatment naïve CLL/SLL patients, including those with del(17p): Subgroup analysis from the SEQUOIA trial

Publication Number: PS1703

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Alessandra Tedeschi

Subsequent therapies and time to second progression-free survival events in chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab

Publication Number: PF601

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Mazyar Shadman

Zanubrutinib vs ibrutinib in treatment-naive chronic lymphocytic leukemia (CLL): Implications for interpreting fixed-duration treatment outcomes from CLL17

Publication Number: PS1718

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Talha Munir

Associations between ECOG performance status and patient-reported outcomes in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: Post hoc analysis from the ALPINE trial

Publication Number: PS2492

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Nicole Lamanna

A longitudinal analysis of patients with CLL/SLL with impaired health-related quality of life scores at baseline who were treated with zanubrutinib versus ibrutinib: A post hoc analysis of ALPINE

Publication Number: PF1398

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Loic Ysebaert

Real-world zanubrutinib treatment patterns in CLL/SLL among US community oncology patients with prior acalabrutinib therapy

Publication Number: PF618

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Jing-Zhou Hou

Patterns of treatment utilization and sequencing across lines of therapy in Waldenström macroglobulinemia: Real-world evidence from the United States

Publication Number: PS2516

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Prashant Kapoor

Real-world comparative analysis of treatment discontinuation with covalent Bruton tyrosine kinase inhibitors in first-line chronic lymphocytic leukemia

Publication Number: PS1710

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Nakhle Saba

Real-world treatment and survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States

Publication Number: PF608

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Ryan Jacobs

A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States

Publication Number: PS2040

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Yucai Wang

Clinical outcomes among patients with relapsed/refractory mantle cell lymphoma receiving zanubrutinib or acalabrutinib in real-world practice in the United States

Publication Number: PF958

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Javier Munoz

Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia

Publication Number: PS2515

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Rhys Williams

Treatment burden among patients aged 75 or older with chronic lymphocytic leukemia and small lymphocytic lymphoma

Publication Number: PF605

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Daniel Ermann

Real-world effectiveness and safety of zanubrutinib in Waldenström macroglobulinemia: Results from the Belgian WIZARD study

Abstract Number: PB3600

Willem Daneels

Real-world experience with zanubrutinib in chronic lymphocytic leukaemia – patient profile, treatment patterns, and safety: Preliminary analysis of French ROZALY study

Abstract Number: PB2898

Florian Bouclet

BRUMIZE: Real-world zanubrutinib use and preliminary safety in R/R marginal zone lymphoma in Europe

Abstract Number: PB3632

Côme Bommier

Indirect comparison of zanubrutinib vs acalabrutinib and ibrutinib efficacy in patients with treatment-naïve chronic lymphocytic leukemia

Abstract Number: PB2895

Mazyar Shadman

Patient-reported outcomes and disease progression in chronic lymphocytic leukemia and small lymphocytic lymphoma: A systematic literature review and gap analysis

Abstract Number: PB2909

Loic Ysebaert

Understanding patients’ perspectives and preferences regarding first-line chronic lymphocytic leukemia treatment across Europe

Abstract Number: PB2934

Lydia Scarfò

Number of deaths avoided with use of zanubrutinib versus ibrutinib for the treatment of chronic lymphocytic leukemia in Europe

Abstract Number: PB2944

Talha Munir

Real-world intravenous immunoglobulin utilization in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma treated with venetoclax plus obinutuzumab vs zanubrutinib

Abstract Number: PB2915

Nicole Lamanna

Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia

Abstract Number: PB2901

Daniel A. Ermann

Exploring the patient and hematologist preference of treatment characteristics for chronic lymphocytic leukemia: A qualitative study in Europe

Abstract Number: PB4474

Lydia Scarfò

Sonrotoclax

Abstract Title

Presentation Details

Lead Author

First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53

Publication Number: S145

Session: s424 Prognostication and first line therapy in CLL

Session Date/Time: June 12, 2026

17:15 – 18:30 CEST

Chan Y. Cheah

Updated safety and efficacy of all-oral sonrotoclax + zanubrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with del(17p)/TP53

Publication Number: PS1697

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Stephen S. Opat

Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib in patients with relapsed/refractory mantle cell lymphoma: Results from a phase 1/1b study

Publication Number: PF933

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Jacob D. Soumerai

Phase 1/2 study of sonrotoclax (BGB-11417) monotherapy in Bruton tyrosine kinase inhibitor–pretreated relapsed/refractory mantle cell lymphoma: A Chinese subpopulation analysis

Publication Number: PF961

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Yuqin Song

Sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2)

Abstract Number: PB2966

Mazyar Shadman

Efficacy of sonrotoclax versus pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison

Abstract Number: PB3626

Toby A. Eyre

Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization

Abstract Number: PB3617

Toby A. Eyre

Risk of tumor lysis syndrome among venetoclax-treated patients with chronic lymphocytic leukemia or mantle cell lymphoma: A real-world study

Abstract Number: PB2896

Alessandra Ferrajoli

BGB-16673

Abstract Title

Presentation Details

Lead Author

BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: A phase 1 CaDAnCe-101 study update

Publication Number: S152

Session: s449 Novel therapies in relapsed/refractory CLL

Session Date/Time: June 14, 2026

11:00 – 12:15 CEST

Stephan Stilgenbauer

Bruton tyrosine kinase (BTK) degrader BGB-16673 in BTK inhibitor–naive patients with CLL/SLL and other B-cell malignancies: Results from the phase 1 CaDAnCe-101 study

Publication Number: PS1693

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Irina Mocanu

BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory Waldenström macroglobulinemia: A phase 1 CaDAnCe-101 study update

Publication Number: PS2033

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Judith Trotman

BGB-16673, a Bruton tyrosine kinase degrader, has low risk of CYP3A-mediated drug-drug interaction (DDI): Phase 1 absorption, distribution, metabolism, and excretion and DDI study results

Publication Number: PS1711

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Judith Trotman

BGB-16673 versus idelalisib + rituximab (R), bendamustine + R, or venetoclax + R re-treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: The phase 3 CaDAnCe-302 trial

Abstract Number: PB2925

Paolo Ghia

Tislelizumab

Abstract Title

Presentation Details

Lead Author

Evaluation of PET-CT metrics and pharmacokinetics in adults receiving tislelizumab for relapsed/refractory classical Hodgkin lymphoma: Ancillary analyses of LYSA phase 2 TIRHOL study BGB-A317-210

Publication Number: PS2028

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Hervé Ghesquières

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. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing and the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study.

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. BEQALZI 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 2,200 patients have been enrolled across the broad sonrotoclax global development program.

About BGB-16673

BGB-16673 is a foundational and potential first-in-class and best-in-class Bruton’s tyrosine kinase (BTK) degrader for the treatment of B-cell malignancies. With 1,100+ patients dosed to date in an extensive global clinical development program, BGB-16673 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, BGB-16673 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 BGB-16673 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 BGB-16673 PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved in over 50 countries, and more than 2 million patients have been treated globally.

Select Important Safety Information for BRUKINSA (zanubrutinib)

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 BEQALZITM (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.

Select Important Safety Information for TEVIMBRA

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

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

(Press release, BeOne Medicines, MAY 21, 2026, View Source [SID1234665950])

Natera to Present 35 Studies at ASCO, Extending Clinical Data Leadership in Oncology

On May 21, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL.

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!

Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management.

"This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. "Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized."

Treatment on MRD (TOMR) in Colorectal Cancer (CRC)

Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting.

In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment.
A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies.
Pan-Cancer MRD

Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis.

In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15).
In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30).
Phased Variant Technology

Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management.

One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases.
In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients.
Platform Expansion: RWD and New Digital Tools

Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO (Free ASCO Whitepaper), a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL.

Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management.

"This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. "Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized."

Treatment on MRD (TOMR) in Colorectal Cancer (CRC)

Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting.

In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment.
A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies.
Pan-Cancer MRD

Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis.

In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15).
In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30).
Phased Variant Technology

Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management.

One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases.
In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients.
Platform Expansion: RWD and New Digital Tools

Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO (Free ASCO Whitepaper), a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels.