On November 20, 2025 Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, reported its Tapestri Single-Cell Targeted DNA + RNA Assay, the first commercial platform to measure genotypic and transcriptional readouts within the same cell. The assay empowers oncology and translational researchers to directly link mutations to their functional consequences, uncovering the mechanisms that drive resistance, relapse, and therapeutic response– advancing precision medicine to enable more effective therapeutic innovation.

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Advancements have been made in mapping clonal architecture in blood cancers via single-cell genotyping. However, linking these genetic mutations to gene expression, the driver of phenotype and treatment response, remains a major challenge. The Tapestri Targeted DNA + RNA Assay unifies both genotyping and gene expression in the same cell, eliminating multi-platform data integration and heavy computational alignment, enabling investigators to observe how mutations influence transcriptional states in acute myeloid leukemia, myelodysplastic syndromes, and engineered cell therapies.

Peer-reviewed work published in Nature Methods using the Tapestri platform showed that cells with higher mutational burden exhibit enhanced tumorigenic gene expression and B-cell-receptor signaling, evidence of the method’s sensitivity and relevance to hematology. Its debut at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 coincides with a broader shift toward functional, single-cell multi-omic profiling in translational hematology.

"The DNA+RNA assay provides powerful resolution into the mutational landscape and cell states within leukemia," says Bobby Bowman, PhD, Assistant Professor, University of Pennsylvania, Department of Cancer Biology. "With this assay, we were able to chart clonal evolution in response to therapy, and resolve not only which clones survived but the gene expression programs that emerged following therapy."

The assay unites targeted genotyping and transcript quantification in a single workflow, analyzing thousands of cells per run and quantifying expression of up to 200 transcripts to link genetic changes with their functional impact. The design preserves existing Tapestri chemistry and instrumentation, allowing current users to add RNA capability without re-validation of laboratory infrastructure or data pipelines.

"For translational and cell therapy researchers, combining DNA and RNA signals from the same cells reveals how variants act in real time," said Adam Sciambi, PhD, Mission Bio CTO and co-founder. "It turns inference into direct observation, an essential step toward mechanistic insights for next-generation therapies."

The assay is currently offered for research use only and will be featured in demonstrations at ASH (Free ASH Whitepaper) on Dec. 6-9, 2025, at Booth #2129, where Mission Bio will highlight use cases spanning therapy resistance, relapse modeling, and preclinical quality assessment.

This launch continues Mission Bio’s leadership in single-cell multi-omics. Adding RNA expression profiling to the established Tapestri platform used worldwide across cancer research, pharmaceutical development, and cell and gene therapy programs demonstrates Mission Bio’s focus in helping investigators truly understand the biological complexity of diseases at the single-cell level. By enabling the simultaneous analysis of genotype and gene expression within the same cells, Mission Bio has established a new analytical standard for translational hematology and engineered cell development.

For more information, you can visit View Source and View Source

(Press release, Mission Bio, NOV 20, 2025, View Source [SID1234660856])

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.

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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 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.

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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 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported the opening of MDS05/D3 MESSAGE, a Phase 2 multi-centre trial investigating amsulostat (SNT-5505) in combination with hypomethylating agent ASTX727 for the treatment of transfusion dependent, low and intermediate risk Myelodysplastic Syndromes (MDS): ALLG | New MDS05 MESSAGE Trial | Transfusion Dependent MDS.

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The Principal Investigator, Associate Professor Anoop Enjeti, commented: "One of the inspirations for this study came from some ground breaking pre-clinical work recently conducted by Heidelberg University that showed a significant increase in red blood cell production when the Syntara drug, amsulostat, was added to a hypomethylating agent that is commonly used in high risk MDS patients. Amsulostat has since been shown to be safe and well tolerated when used in patients with another type of haematological cancer, myelofibrosis, for up to 12 months so we are excited about the potential it might hold for patients with MDS who have very few treatment options".

The multi-centre study will open at 10 hospitals across Australia with up to 30 patients to be recruited for treatment. It aims to reduce the reliance on fortnightly blood transfusions typically required by MDS patients, improving the survival outcomes and lessening the treatment burden.

The trial is being led by the Australasian Leukaemia & Lymphoma Group (ALLG), while being funded by the Australian Government’s Medical Research Future Fund, with contributions from Syntara and Taiho as industry partners.

MDS is a form of blood cancer where patient’s bone marrow fails to produce enough healthy blood cells, causing bone marrow failure. This high treatment burden in transfusion dependent MDS greatly impacts both quality of life for patients as well as placing a heavy load on blood transfusion supply.

Patients with this type of MDS also experience far worse outcomes, with a 5-year survival rate of just 37.3%, and a high risk of progression from MDS to acute myeloid leukaemia (AML), an aggressive and often fatal blood cancer.

Associate Professor Anoop Enjeti said: "Transfusion dependent myelodysplasia has no approved treatments currently available for Australian patients. The MDS05 MESSAGE trial’s new treatment combination aims to improve survival rates and quality of life for patients with this type of MDS by reducing the reliance on regular blood transfusions. Another unique aspect will be the combination of 2 oral medications making this trial more accessible to patients."

ALLG Chief Executive Officer, Delaine Smith, said: "The ALLG is the only collaborative blood cancer clinical trial group in Australasia, conducting clinical trials into MDS, AML and other leukaemias, lymphomas and myeloma. Our independent, clinician-led network enables us to conduct research into all areas of blood cancers, including rarer cancers and areas of high unmet need. We’re excited to launch the MESSAGE clinical trial to improve the outcomes and quality of life for transfusion-dependant MDS patients and delighted to work with Syntara whose original research underpins this new treatment concept."

The commencement of this trial follows (see ASX announcement 18 July 2025) the initiation of AZALOX, a Phase 1b/2 multi-centre study in Germany evaluating amsulostat in combination with 5-Azacitidine for the treatment of high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML). Updates on recruitment and interim safety and efficacy data are anticipated as both studies progress in 2026.

Syntara CEO Gary Phillips commented: "The MESSAGE trial allows us an opportunity to prove the potential of amsulostat in another form of blood cancer, complementary to our lead program in myelofibrosis and the AZALOX study in related MDS indications in Germany. We appreciate the support of the ALLG, Taiho, Professor Enjeti in conducting the trial and the financial support from the MRFF. We look forward to seeing initial results from this study in 2026 and, in the longer term, making a difference for these patients with limited treatment options."

(Press release, Syntara, NOV 20, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/bfd40536-38a4-84f6-6c22-0325db62adbd/03026278.pdf [SID1234660852])

On November 20, 2025 Inhibikase Therapeutics, Inc. (NASDAQ: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of pulmonary arterial hypertension ("PAH"), reported the pricing of its underwritten public offering of 46,091,739 shares of common stock and pre-funded warrants to purchase 22,873,779 shares of common stock. The shares of common stock are being sold at an offering price of $1.45 per share, and the pre-funded warrants are being sold at an offering price of $1.449 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. In addition, Inhibikase has granted the underwriters a 30-day option to purchase up to an additional 10,344,827 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Inhibikase from this offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants. All of the securities being sold in the offering are being offered by Inhibikase. The offering is expected to close on November 24, 2025, subject to the satisfaction of customary closing conditions.

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Jefferies, BofA Securities and Cantor are acting as joint book-running managers for the offering. LifeSci Capital and Oppenheimer & Co. are acting as co-lead managers for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers for the offering.

The securities described above are being offered by Inhibikase pursuant to a shelf registration statement on Form S-3 (No. 333-288213) that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on June 27, 2025. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; BofA Securities, Inc., Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255- 0001, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

(Press release, Inhibikase Therapeutics, NOV 20, 2025, View Source [SID1234660851])