On November 20, 2025 Abbott (NYSE: ABT) and Exact Sciences (NASDAQ: EXAS) reported a definitive agreement for Abbott to acquire Exact Sciences, which will enable it to enter and lead in fast-growing cancer diagnostics segments, serving millions more people. Under the terms of the agreement, Exact Sciences shareholders will receive $105 per common share, representing a total equity value of approximately $21 billion.

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, the companies will accelerate innovation, expand access to life-changing diagnostics, and help more people detect and manage cancer at its earliest, most treatable stages.

Exact Sciences focuses on the early detection of cancer and supporting personalized treatments. Exact Sciences’ comprehensive product offerings support patients and their healthcare providers before, during and after a cancer diagnosis. The company is a leader in cancer screening, precision oncology and genetic testing, helping to detect cancer earlier, guide treatment decisions and monitor for recurrence.

Its product offerings include the Cologuard test, a market-leading noninvasive colorectal cancer screening option; Oncotype DX, which informs personalized treatment decisions for patients with breast cancer; Oncodetect, which identifies molecular residual disease (MRD) to help assess the risk of recurrence and guide follow-up care; and Cancerguard, a multi-cancer early detection blood test.

Approximately 20 million people globally, including 2 million Americans, are diagnosed with cancer every year. These numbers are only expected to rise in the coming years due to population growth, aging and other contributing factors.*

"Exact Sciences’ innovation, its strong brand and customer-focused execution are unrivaled in the cancer diagnostics space, and its presence and strengths are complementary to our own," said Robert B. Ford, chairman and chief executive officer, Abbott. "Abbott has repeatedly taken on the world’s most challenging health issues and made a meaningful impact on the lives of people in areas such as diabetes, cardiovascular disease and infectious diseases. We’re excited to bring Exact Sciences’ people and know-how into Abbott so that together, we can take on the global challenge of cancer."

"Together with Abbott, we can reach more patients, advance earlier detection, and deliver answers that change lives," said Kevin Conroy, chairman and chief executive officer, Exact Sciences. "Abbott’s culture of innovation and global commercial reach will help accelerate our mission of eradicating cancer and expanding access to our tests worldwide, while delivering immediate and substantial value to our shareholders. I want to thank the 7,000 Exact Sciences’ team members for their extraordinary work and dedication — our journey has just begun."

Financial & Operational
Under the terms of the agreement, Abbott will acquire all outstanding shares of Exact Sciences for $105 per common share in cash, at a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion. Abbott’s financing contemplates absorption of Exact Sciences’ estimated $1.8 billion of net debt.

The closing is expected in the second quarter of 2026 and is subject to Exact Sciences’ shareholder approval, as well as receipt of applicable regulatory approvals and other customary closing conditions. The transaction was unanimously approved by both companies’ boards of directors.

Exact Sciences is projected to generate more than $3 billion in revenue this year, with a high teens organic sales growth rate. Once the transaction is completed, Exact Sciences will become a subsidiary of Abbott, and Abbott’s total diagnostics sales will exceed $12 billion annually.

Following the closing, Exact Sciences will maintain its presence in Madison, Wis. Kevin Conroy will remain with the company in an advisory role to support the transition into Abbott and accelerate its global impact in helping to eradicate cancer worldwide.

(Press release, Abbott, NOV 20, 2025, View Source,-a-leader-in-large-and-fast-growing-cancer-screening-and-precision-oncology-diagnostics-segments [SID1234660837])

On November 20, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported its vision to become the world’s leading oncology company with extensive new data from its differentiated hematology portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida, December 6-9. Nearly 50 abstracts have been accepted, including six oral presentations, featuring the company’s three transformative approved and investigational hematology assets – BTK inhibitor BRUKINSA (zanubrutinib), BCL2 inhibitor sonrotoclax, and BTK degrader BGB-16673.

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!

Key presentations include:

SEQUOIA: BRUKINSA demonstrated sustained overall survival (84%; 88% after COVID adjustment) and landmark progression-free survival (PFS) superiority vs bendamustine + rituximab with an estimated 74% PFS at 6 years in treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (Poster Presentation: 2129)
ALPINE: Post-hoc analysis from Phase 3 study of BRUKINSA versus ibrutinib in patients with relapsed/refractory (R/R) CLL/SLL, using longitudinal patient-reported outcomes (PRO) (Oral Presentation: 711)
BGB-11417-201: Phase 1/2 study of sonrotoclax in patients with R/R mantle cell lymphoma (MCL) previously treated with a BTK inhibitor (Oral Presentation: 663)
BGB-11417-101: Updated safety and efficacy results, including undetectable minimal residual disease (uMRD) data, from ongoing Phase 1/1b study of sonrotoclax plus BRUKINSA in treatment-naïve CLL/SLL (Poster Presentation: 3891)
CaDAnCe-101: Updated efficacy and safety results of BGB-16673 in patients with R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) (Oral Presentation: 85; Poster Presentation: 3583)
"Our data at ASH (Free ASH Whitepaper) 2025 raises the bar for patient and physician expectations of what’s possible. Our long-term data drives confidence in duration of response in CLL treatment decisions," said Lai Wang, Ph.D., Global Head of R&D at BeOne. "Six-year SEQUOIA and long-term extension data from patients originally enrolled in ALPINE cement BRUKINSA’s role as the backbone of CLL therapy, and our three innovative B-cell treatment modalities of BTK inhibition, BCL2 inhibition, and BTK degradation have the potential to advance options that evolve with patient needs across all stages of disease."

Additional highlights include:

Never-before-presented clinical data from BeOne’s emerging pipeline will also be shared at the meeting, including in new combinations and disease areas.

BGB-11417-101: Results from Phase 1/1b study:
MRD-guided therapy of sonrotoclax plus obinutuzumab in patients with treatment-naïve CLL/SLL (Oral Presentation: 793)
Initial results of treatment with sonrotoclax plus BRUKINSA plus obinutuzumab in patients with treatment-naïve CLL/SLL (Poster Presentation: 3890)
BGB-11417-202: Phase 2 study of sonrotoclax monotherapy in patients with R/R CLL/SLL (Poster Presentation: 5666)
BGB-11417-105: Initial results from Phase 1b/2 study of sonrotoclax plus carfilzomib and dexamethasone in patients with t(11;14)-positive R/R multiple myeloma (Oral Presentation: 102)
CaDAnCe-101 Preliminary results from the ongoing Phase 1 study of BGB-16673 in patients with R/R Richter’s transformation (Poster Presentation: 3895)
Ongoing clinical data from BRUKINSA continue to demonstrate clinically meaningful benefit for patients with CLL/SLL.

SEQUOIA Arm D: Single-arm study of BRUKINSA plus venetoclax in patients with first-line CLL/SLL, with del(17p) and/or TP53 mutation or without both (Poster Presentation: 5669)
ALPINE thru LTE1: Up to 6 years of follow-up of patients with R/R CLL/SLL who were originally randomized to receive BRUKINSA as part of the ALPINE study and continued BRUKINSA treatment in a long-term extension study (LTE-1) (Poster Presentation: 2123)
Presentations also include data leveraging real-world evidence and validated modeling approaches to refine understanding of real-world experience and outcomes achieved with covalent BTK inhibitors.

Outcomes research:
A model analysis of number needed to treat (NNT) estimates that treating patients with BRUKINSA instead of ibrutinib for CLL could potentially prevent approximately 255 cardiac deaths in the second-line or later (2L+) setting and 266 in the first-line (1L) setting over a 10-year period. (Abstract Number: 13636)
Model evaluating BRUKINSA vs other covalent BTK inhibitors in R/R CLL and the number of patients needed to treat to avoid progression or death (Poster Presentation: 4553)
Observational study examining patient-reported outcomes in U.S. patients with CLL/SLL and treated with BRUKINSA or acalabrutinib in the community oncology setting (Poster Presentation: 2768)
"In CLL, selecting the right therapy for the right patient at the right time is essential, and continuous treatment with BTK inhibitors like BRUKINSA has become central to achieving enduring disease control," said Dany Habr, M.D., Senior Vice President and Head of Medical Affairs, North America & International Markets at BeOne. "Emerging data from real-world settings suggest that BRUKINSA may offer a more manageable side effect profile, including for symptoms such as fatigue, pain, headache – further supporting its role as the BTKi of choice."

BeOne Presentations at ASH (Free ASH Whitepaper) 2025 (organized chronologically by asset)

BRUKINSA: The backbone of the hematology franchise

Abstract Title

Presentation Details

Lead Author
Final analysis of the randomized Phase 2 ROSEWOOD study of zanubrutinib + obinutuzumab vs obinutuzumab monotherapy in patients with R/R follicular lymphoma

Oral Presentation: 227

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: FL and WM

Session Date/Time: December 6, 2025, 2:00-3:30 PM EST

Pier Luigi Zinzani

Sustained efficacy of zanubrutinib vs bendamustine + rituximab in treatment- naïve CLL/SLL with continued favorable survival in non-randomized patients with del(17p): 6-year follow-up in the Phase 3 SEQUOIA study

Poster Presentation: 2129

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Constantine S. Tam

Long-term results of patients receiving zanubrutinib in the Phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with R/R CLL/SLL: Up to 6 years of follow-up with the long-term extension

Poster Presentation: 2123

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Constantine S. Tam

Symptom-based progression-free survival as a clinically relevant and patient-centric endpoint in CLL/SLL: Results from the ALPINE trial

Oral Presentation: 711

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Quality of Life and Supportive Care in Lymphoid Malignancies

Session Date/Time: December 7, 2025, 4:30-6:00 PM EST

Jennifer R. Brown

Progression-free survival in patients with low health-related quality of life treated with zanubrutinib versus ibrutinib monotherapy: Post-hoc analysis of the ALPINE trial

Poster Presentation: 6275

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Quality of Life and Supportive Care in Lymphoid Malignancies

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Loic Ysebaert

Zanubrutinib + venetoclax for treatment-naïve CLL/SLL, including patients with del(17p) and/or TP53 mutation and unmutated immunoglobulin heavy-chain variable status: 3-year results from SEQUOIA arm D

Poster Presentation: 5669

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Mazyar Shadman

Evaluation of factors from established prognostic models in patients with CLL treated with zanubrutinib: A post-hoc analysis of two Phase 3 studies (SEQUOIA and ALPINE)

Poster Presentation: 5681

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Inhye Ahn

Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies: A long-term follow-up

Poster Presentation: 5663

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Mazyar Shadman

Single-arm, open-label, multicenter study of the BTKi zanubrutinib in patients with CD79B-mutated R/R diffuse large B-cell lymphoma

Poster Presentation: 3684

Session Title: Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Li Wang

Sonrotoclax: Potential best-in-class next-generation BCL2 inhibitor

Abstract Title

Presentation Details

Lead Author

Initial Phase 1b/2 study results with sonrotoclax in combination with carfilzomib and dexamethasone in patients with t(11;14)-positive R/R multiple myeloma

Oral Presentation: 102

Session Title: Multiple Myeloma: Pharmacologic Therapies: Advancing the Standard: Improving Myeloma Treatment through Diagnosis, Maintenance and Relapse

Session Date/Time: December 6, 2025, 10:45-11:00 AM EST

Hang Quach

A Phase 3, randomized, open-label, multicenter study of sonrotoclax plus anti-CD20 antibody therapies vs venetoclax plus rituximab in patients with R/R CLL/SLL (CLL-RR1/CELESTIAL-RRCLL)

Trial-in-progress Poster Presentation: 2137

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Othman Al-Sawaf

Sonrotoclax monotherapy in patients with relapsed/refractory mantle cell lymphoma previously treated with BTKi: Early results from a Phase 1/2 study

Oral Presentation: 663

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological – Novel Treatments for and Insights into Mantle Cell Lymphoma

Session Date/Time: December 7, 2025, 4:30-6:00 PM EST

Michael Wang

Frontline treatment of sonrotoclax and zanubrutinib for CLL/SLL demonstrates high undetectable minimal residual disease rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing Phase 1/1b study

Poster Presentation: 3891

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Constantine S. Tam

Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naïve CLL/SLL: Initial results from an ongoing Phase 1/1b study, BGB-11417-101

Poster Presentation: 3890

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Jacob D. Soumerai

MRD-guided therapy of sonrotoclax + obinutuzumab in patients with treatment-naive CLL: Initial results from an ongoing Phase 1/1b study, BGB-11417-101

Oral Presentation: 793

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: MRD Guided Therapy and Emergence of Resistance

Session Date/Time: December 8, 2025, 10:30 AM-12:00 PM EST

Marc S. Hoffmann

Primary analysis of a multicenter, open-label, Phase 2 study of sonrotoclax monotherapy in patients with R/R CLL/SLL

Poster Presentation: 5666

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Shuhua Yi

BGB-16673: Potential first-in-class BTK protein degrader

Abstract Title

Presentation Details

Lead Author

Updated efficacy and safety results of the BTK degrader BGB-16673 in patients with R/R CLL/SLL from the ongoing Phase 1 CaDAnCe-101 study

Oral Presentation: 85

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Treatment of CLL in Relapse and in Richter Transformation

Session Date/Time: December 6, 2025, 9:30-11:00 AM EST

Inhye E. Ahn

CaDAnCe-104, an ongoing, open-label, Phase 1b/2 master protocol study of BTK degrader BGB-16673 in combination with other agents in patients with R/R B-cell malignancies

Trial-in-Progress Poster Presentation: 1839

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Chan Y. Cheah

Updated efficacy and safety results of the BTK degrader BGB-16673 in patients with R/R indolent non-Hodgkin lymphoma from the ongoing Phase 1 CaDAnCe-101 study

Poster Presentation: 3584

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Romain Guièze

Preliminary efficacy and safety of the BTK BGB-16673 in patients with R/R Richter transformation: Results from the ongoing Phase 1 CaDAnCe-101 study

Poster Presentation: 3895

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Meghan C. Thompson

Updated efficacy and safety results of the BTK BGB-16673 in patients with R/R Waldenström macroglobulinemia from the ongoing Phase 1 CaDAnCe-101 study

Poster Presentation: 3583

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Constantine S. Tam

CaDAnCe-304, a Phase 3, open-label, randomized study to evaluate the safety and efficacy of BTK degrader BGB-16673 compared with pirtobrutinib in patients with R/R CLL/SLL

Trial-in-progress Poster Presentation: 5691

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Meghan C. Thompson

Other hematology assets: BGB-21447, next-generation BCL2 inhibitor

Abstract Title

Presentation Details

Lead Author

Preliminary results from a Phase 1/1b first-in-human study of BGB-21447, a next-generation BCL2 inhibitor, in patients with B-cell non-Hodgkin lymphoma

Poster Presentation: 1910

Session Title: Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Fei Li

Integrative evidence generation and health economics related to BRUKINSA

Abstract Title

Presentation Details

Lead Author

Matching-Adjusted Indirect Comparison

Indirect comparison of efficacy of zanubrutinib vs ibrutinib for the treatment of R/R MCL

Poster Presentation: 5365

Session Title: Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Toby A. Eyre

A matching-adjusted indirect comparison of zanubrutinib vs venetoclax + ibrutinib in treatment-naive CLL

Abstract Number: 7756

Talha Munir

Health Economic and Outcomes Research

Outcomes during BTKi treatment for CLL: Insights from remote therapeutic monitoring

Poster Presentation: 2768

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Gurjyot Doshi

Number needed to treat to avoid progression or death: Zanubrutinib vs other covalent BTKis in R/R CLL

Poster Presentation: 4553

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Mazyar Shadman

Estimated cardiac deaths associated with treating CLL with ibrutinib versus zanubrutinib in the United States

Abstract Number: 13636

Jennifer R. Brown

Number of patients needed to treat to prevent one atrial fibrillation event with zanubrutinib versus ibrutinib and acalabrutinib in B-cell malignancies

Abstract Number: 14445

Talha Munir

Number of cardiac deaths associated with ibrutinib versus zanubrutinib for the treatment of CLL: A European risk-based estimation

Abstract Number: 14028

Talha Munir

Real-World Evidence

Mediators of racial and ethnic inequities in access to front-line therapies for CLL in the United States: A real-world evidence study

Poster Presentation: 2720

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Jacqueline C. Barrientos

Real-world treatment patterns and biomarker utilization among patients aged ≥65 years with CLL/SLL from 2020 to 2024

Poster Presentation: 2723

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Paul Hampel

Chemo ± immunotherapy remains utilized for CLL in the real-world practice: Unmet needs, treatment patterns, and age disparities in the United States

Poster Presentation: 2762

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I

Session Date/Time: December 6, 2025, 5:30-7:30 PM EST

Javier Pinilla-Ibarz

Impact of testing for genetic markers on treatment selection and clinical outcomes among patients with CLL

Poster Presentation: 3894

Session Title: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Brian Koffman

Treatment patterns and outcomes among patients treated with second-generation BTK inhibitors in CLL

Poster Presentation: 4528

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Aryan Ayat

Changes in real-world treatment patterns over time by patient characteristics and time burden of treatment in CLL/SLL

Poster Presentation: 6283

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Mengyang Di

Real-world treatment patterns and patient characteristics of venetoclax combination time-limited therapy for CLL

Poster Presentation: 6317

Session Title: Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III

Session Date/Time: December 8, 2025, 6:00-8:00 PM EST

Jing-Zhou Hou

Real-world treatment utilization, sequencing, and outcomes in mantle cell lymphoma: Emerging treatment patterns in the United States

Abstract Number: 13378

Alvaro Alencar

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

Abstract Number: 8798

Jing-Zhou Hou

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

Abstract Number: 7341

Ryan Jacobs

Real-world CLL-specific biomarker testing patterns and frontline treatment patterns in patients with CLL/small lymphocytic lymphoma

Abstract Number: 7773

Timothy Reynolds

Real-world CLL/SLL treatment patterns at Florida Cancer Specialists & Research Institute among patients receiving zanubrutinib immediately following prior BTKi therapy

Abstract Number: 13894

Amanda Warner

Patient Preference

Patient preferences and factors affecting patient treatment decisions for CLL in Japan

Poster Presentation: 4406

Session Title: Health Services and Quality Improvement: Lymphoid Malignancies: Poster II

Session Date/Time: December 7, 2025, 6:00-8:00 PM EST

Sikander Ailawadhi

Evaluating patient preferences for CLL in Korea: A discrete choice experiment

Abstract Number: 4019

Byung Woo Yoon

Systemic Literature Review

Patients with high-risk features in mantle cell lymphoma: A systematic literature review of clinical trials and real-world studies

Abstract Number: 14130

Christine E. Ryan

For additional information about our presence at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition, please visit our meeting hub: congress.beonemedicines.com.

About Sonrotoclax (BGB-11417)

Sonrotoclax is a next-generation and potentially best-in-class investigational B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Studies in the lab and during 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 and is in development as a monotherapy and in combination with other therapeutics, including BRUKINSA. Notably, in early clinical trials, sonrotoclax plus BRUKINSA has demonstrated rapid and unprecedented undetectable minimal residual disease (uMRD) rates in treatment-naïve patients with CLL. To date, more than 2,200 patients have been enrolled across the broad global development program.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for sonrotoclax for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). In addition, the FDA has granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia, as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

About BGB-16673

BGB-16673 is a potential first-in-class Bruton’s tyrosine kinase (BTK) protein degrader and is the most advanced protein degrader in the clinic, with nearly 800 patients dosed to date in an extensive global clinical development program. 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 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.

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

The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 247,000 patients have been treated globally.

Select Important Safety Information

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.

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

(Press release, BeOne Medicines, NOV 20, 2025, View Source [SID1234660853])

On November 20, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2025 financial results and provided a corporate update.

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 third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. "Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers."

Recent Corporate Highlights:

● In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis, with limited benefit from existing therapies, and the pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs. For more information, please see here: View Source

● In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

Expected Upcoming Milestone Targets:

● First patient treated in U.S. GBM pilot study in Q4 2025. For more information, please see here: View Source

● Response from Japan’s PMDA around year end 2025 to the application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q1 2026. For more information, please see here: View Source

● Completion of patient recruitment in pancreatic cancer pilot study in the U.S. by the end of Q1 2026. For more information, please see here: View Source

Financial Results for Nine Months Ended September 30, 2025

Research and Development expenses for the nine months ended September 30, 2025 were $22.5 million, compared to $19.5 million for the same period in 2024, primarily due to an increase in employee compensation and benefits, costs of raw materials and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower share-based compensation expenses and travel expenses.

Marketing expenses for the nine months ended September 30, 2025 were $1.4 million, compared to $1.7 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities and travel expenses.

General and Administrative expenses for the nine months ended September 30, 2025 were $5.8 million, compared to $4.6 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal and IR expenses), offset by a decrease in travel expenses and D&O insurance costs.

Financial expense, net, for the nine months ended September 30, 2025 was $0.6 million, compared to financial income, net, of $3.5 million for the same period in 2024, primarily due to an increase in the remeasurement of warrants, a decrease in interest from bank deposits, and changes in foreign exchange rates.

For the nine months ended September 30, 2025, the Company had a net loss of $30.5 million, or $0.39 per share, compared to a net loss of $22.3 million, or $0.32 per share, in the nine months ended September 30, 2024.

Balance Sheet Highlights

As of September 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $75.9 million, compared to $62.9 million at December 31, 2024.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, NOV 20, 2025, View Source [SID1234660838])

On November 20, 2025 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy.

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!

Zipalertinib previously received Breakthrough Therapy Designation in 2021, which with FDA agreement, allows submission of portions of the application as they are completed. The companies anticipate completion of the NDA submission in the first quarter of 2026 with an associated request for priority review.

The NDA submission is based on the primary efficacy data from the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy.

Positive results from the REZILIENT1 trial were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and were simultaneously published in the Journal of Clinical Oncology.

About REZILIENT1
REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoints were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Adverse events were characterized and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE v5.0).

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations
NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,2 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, NOV 20, 2025, View Source [SID1234660855])

On November 20, 2025 Alexion and AstraZeneca reported that its Rare Disease Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the US for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

The approval by the US Food and Drug Administration (FDA) was based on positive results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population. Data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The Lancet.

NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system. Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.4,5 PN may appear later in a person’s life and can grow and become large, leading to pain, disfigurement and muscle weakness, among other debilitating symptoms.

Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and Investigator of the KOMET trial, said: "The KOMET Phase III trial, which builds on the established clinical profile of Koselugo and its real-world use in paediatric patients, underscores its potential to address the substantial and oftentimes progressive clinical burdens associated with PN in adulthood. This approval reaffirms the role of Koselugo as a strong option for the treatment of adult and paediatric patients with NF1 PN."

Marc Dunoyer, Chief Executive Officer, Alexion, said: "This expanded approval of Koselugo in adults with NF1 PN, together with the recently approved granule formulation for young children aged one year and older, enables much-needed continuity of care and supports patients across the disease journey in the US. As the first approved therapy in NF1 PN, backed by more than a decade of clinical evidence, Koselugo has transformed the treatment standard for this rare disease."

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!

(Press release, AstraZeneca, NOV 20, 2025, View Source [SID1234660839])

Annette Bakker, PhD, Chief Executive Officer, Children’s Tumor Foundation, said: "We celebrate this FDA approval of Koselugo for adults with NF1 plexiform neurofibromas-a major step forward for NF patients everywhere. Koselugo has already changed what is possible for children with NF1, and now adults will benefit from that same progress. It is proof that NF research is delivering real results and opening the door to even more treatment options. This milestone shows what can be achieved when scientists, clinicians, industry and the NF community work together with one focus: getting effective treatments to patients faster."

In the primary analysis of the KOMET Phase III trial, Koselugo showed a statistically significant and clinically meaningful overall response rate (ORR) of 20% (n=14/71, 95% confidence interval [CI]: 11, 31) compared to 5% with placebo (n=4/74, 95% CI: 2, 13; p=0.011) by cycle 16, with 86% of patients on Koselugo having an observed duration of response (DOR) of at least 6 months. After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles.1

The safety of Koselugo in the KOMET Phase III trial was consistent with its known profile and established use in paediatric patients.2

Koselugo has been recently approved in the EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase III trial, and additional regulatory reviews are ongoing. In the US, Koselugo granules have recently been approved for paediatric patients one year of age and older with NF1 PN.

Notes

NF1
NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene.3,4 NF1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in up to 50% of patients, tumours called plexiform neurofibromas (PN) may develop on the nerve sheaths.4,5 These PN can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.4,5

KOMET
KOMET is a global Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of Koselugo in adults with NF1 who have symptomatic, inoperable PN. The trial enrolled 145 adults from 13 countries across North America, South America, Europe, Asia and Australia, with participants’ baseline characteristics, including gender and distribution of PN, reflective of the global adult NF1 patient population. Patients were enrolled and randomised to receive Koselugo or placebo (1:1) for 12 28-day cycles. Participants were required to have diagnosis of NF1, at least one symptomatic, inoperable PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrolment.2,6

The primary endpoint is confirmed overall response rate (ORR) by cycle 16 as assessed by ICR. ORR is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume). Secondary endpoints include improved PN-related pain and health-related quality of life (HRQoL) at cycle 12.2,6

After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive Koselugo.2,6

Koselugo
Koselugo (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumour cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, Koselugo slows down the growth of tumour cells and, therefore, the PN growth.

Koselugo is approved in the US, EU, Japan, China and other countries for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN.

Koselugo is approved in the US, EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN, and additional regulatory reviews are ongoing.

Koselugo has been granted Orphan Drug Designation in the US, EU, Japan and other countries for the treatment of NF1.