On May 30, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported results from the ENZAMET trial presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The analysis demonstrates that the Decipher Prostate test identifies which men with metastatic prostate cancer benefit from adding the chemotherapy docetaxel to standard hormonal therapy (ADT plus enzalutamide), known as triplet therapy, and who can safely avoid it, providing the first Level 1B 1 evidence for a genomic test guiding this decision. Complementary data presented at the meeting also reinforce Decipher Prostate’s clinical utility in high-risk localized disease.

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Approximately 334,000 men are diagnosed with prostate cancer annually in the United States, including about 30,000 who present with metastatic disease at diagnosis.2, 3 While recent treatment advances have improved outcomes, clinicians still lack precision tools to guide chemotherapy decisions in this setting.

"For the first time, the ENZAMET trial analysis shows that a genomic test can guide the decision to add chemotherapy to standard of care hormonal therapy in metastatic prostate cancer," said Prof. Christopher Sweeney, M.B.B.S., DHS., Lead Investigator, South Australian Immunogenomics Cancer Institute, Adelaide University. "Decipher Prostate identifies which patients benefit from treatment intensification, and which can be safely spared chemotherapy, giving clinicians an actionable, evidence-based answer."

The ENZAMET findings build on prior validation in the STAMPEDE and CHAARTED trials, where Decipher Prostate identified patients most likely to benefit from adding docetaxel to ADT alone. ENZAMET advances that evidence with the first demonstration that the test predicts chemotherapy benefit when added to doublet therapy (ADT plus an ARPI).

Metastatic Disease: Identifying Which Men Benefit from Chemotherapy

The ENZAMET trial is an international, randomized Phase III study conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Researchers performed a pre-specified biomarker analysis using the Decipher Prostate test in 634 patients to assess whether the test could predict benefit from adding chemotherapy to standard hormonal therapy with a median follow-up of 5.6 years.

Results showed:

Improved outcomes guided by Decipher Prostate: Patients with higher Decipher scores (>0.85) and high-volume disease who received triplet therapy had clinically meaningful better survival compared to those on standard hormonal therapy alone.
Patients can be spared from chemotherapy: Patients with lower Decipher scores showed no benefit from adding chemotherapy, suggesting it may be safely avoided.
Practice-changing evidence: The treatment-by-biomarker interaction was statistically significant (p=0.043), providing Level 1B evidence for the test’s predictive value.
Overcoming aggressive disease: Patients with higher Decipher scores who received triplet therapy had more aggressive disease features, yet achieved comparable survival to lower-risk patients on doublet therapy, suggesting chemotherapy offset the poor prognostic effects of aggressive disease biology.
Localized Disease: Identifying Which High-Risk Patients Need Treatment Intensification

Complementing the ENZAMET findings, a combined analysis of four mature NRG/RTOG trials presented at ASCO (Free ASCO Whitepaper) 2026 adds to Decipher Prostate’s growing body of evidence into high-risk localized prostate cancer.

Key findings include:

Improved prognostic accuracy: Decipher Prostate significantly improved prognostic accuracy for survival outcomes compared to clinical variables alone.
Refined risk classification: Combining NCCN clinical risk classification with Decipher Prostate reclassified approximately 1 in 4 patients.
Expanded population for treatment intensification: Results also show many more clinically high-risk patients may benefit from intensification with ARPI.
"Decipher Prostate is the most validated transcriptomic test across the full prostate cancer continuum – from active surveillance through metastatic disease," said Elai Davicioni, Ph.D., Veracyte’s Medical Director, Urology. "For clinicians, that means a clearer answer at every decision point. For patients, it means greater confidence that their treatment is guided by the biology of their disease, and not guesswork."

(Press release, Veracyte, MAY 30, 2026, View Source [SID1234666241])

On May 29, 2026 Alaw Therapeutics, Inc. ("Alaw"), a clinical-stage biotechnology company developing precision oncology therapeutics designed to control oncogenic proliferation, tumor survival, and therapeutic resistance, reported two major pipeline milestones advancing its next-generation cyclin-dependent kinase (CDK) inhibitor portfolio.

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The announcements include:

Dosing of first patients in its Phase 1a/b clinical trial evaluating AL-605, Alaw’s selective, brain-penetrant CDK2 inhibitor, in patients with CCNE1-amplified solid tumors
Drug candidate nomination of AL-433, Alaw’s selective, brain-penetrant CDK4 inhibitor, with first-in-human clinical entry planned for Q4 2026
"These milestones represent an important inflection point for Alaw and for CDK-directed oncology," said Idean Marvasty, President and CFO of Alaw. "The inability to achieve meaningful CNS exposure has remained a fundamental limitation, leaving patients with brain metastases and primary CNS tumors underserved by targeted cell-cycle therapies. AL-605 and AL-433 were specifically engineered to address that challenge through enhanced selectivity of CDK inhibition combined with robust brain penetration."

AL-605: Phase 1a/b Study Initiated for Selective Brain-Penetrant CDK2 Inhibitor

Alaw has initiated a Phase 1a/b clinical trial evaluating AL-605 in patients with cyclin E (CCNE1)-amplified solid tumors. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, while incorporating prospective biomarker-based patient selection strategies intended to enrich for tumors dependent on CDK2 signaling.

The trial is enrolling two biomarker-defined populations:

Patients with hormone receptor-positive breast cancer that has progressed following CDK4/6 inhibitor therapy and exhibits CCNE1 amplification or overexpression, a setting strongly associated with CDK2-mediated resistance
Patients with CCNE1-amplified solid tumors more broadly, including ovarian, endometrial, gastric, esophageal, and triple-negative breast cancers
The Phase 1a portion follows a standard dose-escalation design, while Phase 1b expansion cohorts are intended to confirm the recommended Phase 2 dose and evaluate early clinical activity. Interim data are anticipated in the second half of 2026.

Addressing a Critical CNS Limitation in CDK2 Therapy

CDK2 inhibition is increasingly recognized as a central strategy for overcoming resistance to CDK4/6 inhibitors, which have transformed the treatment landscape for hormone receptor-positive breast cancer but are ultimately limited by the emergence of CDK2-driven bypass signaling.

However, currently available and emerging CDK2 inhibitors demonstrate limited blood-brain barrier penetration, leaving the CNS as a pharmacologic sanctuary where resistant tumor cells can survive and proliferate. By achieving robust and selective CNS CDK2 inhibition, AL-605 is designed to address both systemic disease and intracranial tumor progression, including brain metastases arising from CDK2-dependent tumors.

Preclinical studies have demonstrated that AL-605 achieves CNS exposure exceeding leading comparator CDK2 inhibitors and produces meaningful antitumor activity in intracranial tumor models, including glioblastoma and triple-negative breast cancer brain metastases.

AL-433: Selective Brain-Penetrant CDK4 Inhibitor Advances Toward First-in-Human Development

Alaw also announced the nomination of AL-433, its selective, brain-penetrant CDK4 inhibitor, as a development candidate, with first-in-human clinical studies planned for Q4 2026.

AL-433 targets tumors driven by dysregulation of the CDK4-cyclin D1-Rb-E2F axis, a central regulator of G1-to-S phase cell-cycle progression frequently altered across aggressive solid tumors.

The program is designed to address two fundamental limitations of the currently approved CDK4/6 inhibitor class:

Selective CDK4 Inhibition. AL-433 was engineered for high selectivity toward CDK4 over CDK6 with the goal of preserving antitumor efficacy while substantially improving tolerability. Reduced CDK6 inhibition may enable uninterrupted dosing and expand combination opportunities with immunotherapies and other targeted agents.
CNS Exposure and Brain Tumor Activity. Approved CDK4/6 inhibitors are substrates for efflux transporters at the blood-brain barrier and achieve minimal CNS exposure, limiting activity against glioblastoma, CDK4-amplified brain tumors, and brain metastases. AL-433 was specifically optimized for brain permeability and is designed to enable clinically meaningful CDK4 inhibition within the CNS.
Preclinical studies demonstrated that AL-433 achieves near-complete blood-brain barrier penetration, resulting in direct intracranial target engagement and antitumor activity in CDK4-dependent CNS tumor models.

AL-433 has been well tolerated in multi-species preclinical safety studies, and GLP toxicology studies are ongoing in support of clinical advancement. Planned clinical studies are expected to permit enrollment of patients with active CNS tumors or brain metastases, a population historically excluded from trials evaluating CDK4/6 inhibitors.

"The convergence of selectivity, brain penetrance, and rational combination strategy is what makes the pipeline fundamentally differentiated," added Marvasty. "We are not developing conventional next-generation CDK inhibitors. We are building the first CDK-directed therapies designed to follow the tumor wherever it goes, including the brain."

About AL-605

AL-605 is a selective, brain-penetrant CDK2 inhibitor designed for the treatment of CCNE1-amplified solid tumors and CDK2-mediated resistance to CDK4/6 inhibitors. The molecule achieves significant CNS exposure and has demonstrated antitumor activity in preclinical intracranial tumor models. AL-605 is currently being evaluated in a Phase 1a/b clinical study.

About AL-433

AL-433 is a selective, brain-penetrant CDK4 inhibitor designed to achieve highly selective inhibition of CDK4 over CDK6 while maintaining near-complete blood-brain barrier penetration. The program is intended to address both the hematologic toxicity and CNS limitations associated with approved CDK4/6 inhibitors and has demonstrated antitumor activity in preclinical CDK4-dependent CNS tumor models, including glioblastoma. Drug candidate nomination has been achieved, and first-in-human clinical studies are planned for Q4 2026.

(Press release, Alaw Therapeutics, MAY 29, 2026, View Source [SID1234666237])

On May 29, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, will present two poster presentations of pivotal research abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. This research delivers advanced intelligence to accelerate oncology trials by optimizing patient-centric breast cancer protocols and definitively validating tocilizumab’s efficacy for CAR T–induced Cytokine Release Syndrome (CRS).

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The research (abstracts #11027 and #7027 at booth #30099), conducted by the Medidata Research Alliance, provides valuable insights for oncologists and clinical trial sponsors to refine studies with foresight and strengthen patient outcomes.

"Oncology trials represent some of the most intricate and demanding work in clinical research," said Sheila Diamond, MS, CGC, director, Scientific Engagement, Medidata. "By leveraging decades of clinical research expertise, powered by one of the largest clinical trial datasets in the world, we are delivering the actionable intelligence needed to accelerate cancer breakthroughs. We are transforming trial execution by driving patient-centric protocol design to boost enrollment and, simultaneously, providing definitive clinical validation for treatments of CAR T–induced CRS."

Protocol Optimization in Breast Cancer Clinical Trials

Quantifying the impact of protocol design on enrollment and dropout rates in breast cancer clinical trials. Abstract #11027 (June 1, 2026, 09:00-12:00 CDT timezone)

The analysis by Medidata and Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health, validates a predictive algorithm that quantifies the impact of patient-centric protocol design on enrollment and retention rates in breast cancer trials. The research identified specific procedures that acted as barriers to entry and others that drove retention. Key findings were:

10-23% reduction in enrollment rates associated with the inclusion of Positron Emission Tomography (PET) Imaging in select protocols where PET imaging was considered a key driver of operational outcomes
Up to 6% enrollment increases associated with bone density imaging, abdominal and pelvic imaging, and tumor and biopsy procedures
Up to 10% reductions in dropout rates were seen with the use of blood cell analyses, biomarker testing, and assessment questionnaires overall
The analysis leverages Medidata Protocol Optimization, part of the Medidata Study Experience, which transforms trial design and execution by leveraging AI trained on proprietary, cross-industry data to evaluate planned protocols against how similar clinical studies have performed, helping sponsors identify and mitigate risks proactively.

"Patient recruitment and retention is one of the greatest obstacles in clinical trials, directly impeding the speed at which patients receive potentially life-changing therapies," said Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health. "Our joint research with Medidata moves past simply identifying this challenge; it delivers quantifiable evidence that pinpoints the exact burdens and benefits of specific protocol steps. This data is critical for oncologists and sponsors to proactively design patient-centric trials, ensuring better enrollment, retention, and trial continuity."

Evaluating the Efficacy of Tocilizumab for CAR T–induced Cytokine Release Syndrome

Efficacy of tocilizumab in resolving CAR T–induced Cytokine Release Syndrome: A pooled clinical trial analysis of patients with B-cell lymphoma. Abstract #7027 (June 1, 2026, 09:00-12:00 CDT timezone)

The collaborative study by Medidata, Mayur Narkhede, MD of Mercy Cancer Institute and Sean Patrick Bliven, MD of the University of Alabama, Birmingham, examined data from multinational clinical trials spanning 2,300 patients with B-cell lymphoma on the Medidata Platform. This investigation verifies the effectiveness of tocilizumab for addressing CAR T–induced CRS (Chimeric Antigen Receptor T-cell induced Cytokine Release Syndrome) across a large patient population. This patient population was integrated from multiple multinational trials using AI-powered standardization pipelines. Key observations from the research were:

66% of the 680 patients achieved complete response with a median treatment time of four days
34% of patients did not meet the complete response criteria, highlighting a critical need for alternative rescue therapies to tocilizumab in more persistent cases
"This research is incredibly valuable in confirming that tocilizumab is a highly effective treatment for the majority of patients experiencing CAR T–induced CRS, although it also reinforces the need for further research into other treatment strategies for those who do not see clinical benefit," said Mayur Narkhede, MD, oncologist at Mercy Cancer Institute.

"It also demonstrates the power of industry collaborations such as the Medidata Research Alliance to combine knowledge of the treatment landscape and vast, robust historical clinical data sets to generate insights that may not have otherwise been researched," said Sean Patrick Bliven, MD, oncologist at University of Alabama, Birmingham.

(Press release, Medidata, MAY 29, 2026, https://www.globenewswire.com/news-release/2026/05/29/3303551/0/en/medidata-champions-collaborative-scientific-advancement-at-asco-with-new-research-on-oncology-protocol-optimization-and-car-t-efficacy.html [SID1234666236])

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 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%).

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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])