On December 4, 2025 PreciseDx, the leading innovator behind PreciseBreast, a novel AI digital pathology test, reported the upcoming presentation of three abstracts that further validate the test’s ability to assess risk of recurrence in early-stage breast cancer. Ongoing studies aim to demonstrate PreciseBreast’s ability to predict treatment benefit.

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Three abstracts will be presented during the annual San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12, 2025, in San Antonio, TX. These presentations underscore the growing momentum and clinical success of PreciseBreast which utilizes our proprietary AI platform to combine AI-enabled image feature data with key clinical factors to deliver a PreciseBreastⓇ Score that accurately stratifies patients by recurrence risk.

SABCS-accepted abstracts presented by PreciseDx

PS113-13: Clinical validation of an Artificial Intelligence digital pathology-based prognostic test to predict risk of recurrence using biopsy specimens from patients with invasive breast cancer

Author/Presented by: Michael J. Donovan, PhD, MD
Poster Presentation: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM
PS4-12-28: A novel approach for phenotyping triple negative breast cancer using an Artificial Intelligence digital pathology-based prognostic test to assess recurrence risk and response to therapy

Author/Presented by: Nicholas Stanzione MD, David Geffen School of Medicine, UCLA
Poster Presentation: Thursday, December 11, 2025, 5:00 PM – 6:30 PM
SABCS-accepted abstract presented by Lankenau Medical Center/Main Line Health

PS3-06-02: Prospective Evaluation of "PreciseBreast" AI Tool in Early-Stage Invasive Breast Cancer Risk Stratification

Author/Presented by: Lankenau Medical Center, Main Line Health, Talar Telvizian, MD
Poster Presentation: Thursday, December 11, 2025, 12:30 PM – 2:00 PM
"These results build on our prior publications validating PreciseBreast’s clinical and analytical accuracy in early-stage invasive breast cancer by demonstrating the ability to use the patient’s biopsy specimen to risk stratify as well as advancing our understanding of patients with triple negative breast cancer," shared Eric Converse, CEO of PreciseDx. "We’re particularly excited about the independent, real-world experience at Lankenau Medical Center using PreciseBreast in patients with HR+, HER2- early breast cancer and continuing our collaboration with NSABP to further evaluate PreciseBreast’s ability to predict chemotherapy benefit in this population."

(Press release, PreciseDx, DEC 4, 2025, View Source [SID1234661144])

On December 4, 2025 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that it has received clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global registrational Phase III study (POLARIS-1; NCT06051409) of its compound under investigation, olverembatinib, in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). As the second global registrational Phase III study of olverembatinib that has been cleared by regulators in the US and Europe, the POLARIS-1 study is simultaneously enrolling patients across trial centers in multiple countries in order to accelerate olverembatinib’s path to registration worldwide, particularly in the US and European markets.

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The POLARIS-1 trial is a global, multicenter, randomized controlled, open-label Phase III study designed to evaluate the efficacy and safety of olverembatinib in combination with chemotherapy in newly diagnosed patients with Ph+ ALL. The POLARIS-1 study was also initiated in China after it was cleared by the China Center for Drug Evaluation (CDE) in 2023.

The POLARIS-1 study is set to release its first dataset at the upcoming 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data disclosed in the ASH (Free ASH Whitepaper) 2025 abstract showed that among treatment-naïve patients with Ph+ ALL who received olverembatinib in combination with low-intensity chemotherapy, the minimal residual disease (MRD) negativity rate and the molecular MRD-negative complete response (CR) rate at the end of three treatment cycles both reached approximately 65%, which significantly improved the efficacy reported for other drugs in the same class. Notably, the combination regimen also demonstrated favorable clinical benefit in patients with certain high-risk subtypes such as those harboring the IKZF1plus mutation. In addition, the combination regimen demonstrated a favorable safety profile, with a low incidence of adverse events which were mostly manageable.

Accounting for 20%-30% of all ALL cases in adults, Ph+ ALL is commonly associated with a disproportionately high incidence in the elderly population, a high relapse rate, short disease-free survival, and poor prognosis. Prior to the introduction of tyrosine kinase inhibitors (TKIs), chemotherapy-only treatment delivered a five-year overall survival (OS) rate of less than 20%. The clinical adoption of TKIs has resulted in a new clinical paradigm for patients with Ph+ ALL. However, first- and second-generation TKIs have considerable limitations in the treatment of Ph+ ALL.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Clearances from the U.S. FDA and the EMA for this global registrational Phase III study mark a significant step forward in the global development of olverembatinib in Ph+ ALL. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will press ahead with the clinical development of olverembatinib in Ph+ ALL and strive to bring a new treatment option to patients around the world as soon as possible."

Developed by Ascentage Pharma, olverembatinib is an orally administered, third-generation TKI and the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. Olverembatinib has already been approved in China in multiple indications in drug-resistant chronic myeloid leukemia (CML) and all of the approved indications are now covered by the China National Reimbursement Drug List (NRDL). Being developed for the treatment of Ph+ ALL, olverembatinib has received consecutive recommendations in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and a Breakthrough Therapy Designation by the China CDE.

On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

* Olverembatinib is currently under investigation and has not yet been approved by the FDA in the US.

(Press release, Ascentage Pharma, DEC 4, 2025, View Source [SID1234663141])

On December 4, 2025 AstraZeneca reported its ambition to redefine haematology care with new data from its diverse pipeline and portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, 6-9 December 2025.

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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

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This year’s ASH (Free ASH Whitepaper) congress will feature the Company’s largest presence to date, with 65 abstracts across eight approved and investigational medicines, including 15 oral presentations.

Key presentations include:

Phase I trial of surovatamig: Updated results at three-year follow up from the ongoing first-in-human trial of surovatamig, a CD19xCD3 T-cell engager, in relapsed/refractory (R/R) follicular lymphoma (FL) (Oral Abstract #1005).
DURGA-1 Phase Ib/II study: Initial data for AZD0120 in patients with R/R multiple myeloma (MM). AZD0120 is an investigational BCMAxCD19 chimeric antigen receptor T-cell (CAR T) therapy (Oral Abstract #269).
ECHO Phase III trial: Results after 50 months of follow up evaluating Calquence (acalabrutinib) plus bendamustine and rituximab in the first-line treatment of mantle cell lymphoma (MCL) (Oral Abstract #885).
ALXN1210-TMA-314 Phase III trial: Additional results from the open-label trial evaluating Ultomiris (ravulizumab) in paediatric patients with haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) (Oral Abstract #1052).
Anas Younes, Senior Vice President, Haematology R&D and Chief Medical Officer, AstraZeneca, said: "We are advancing a broad pipeline of investigational therapies with the potential to redefine patient care across multiple types of blood cancer. At ASH (Free ASH Whitepaper), we are sharing meaningful progress with early efficacy and safety data for AZD0120, our first cell therapy, in multiple myeloma, and for surovatamig, a novel T-cell engager, in B-cell malignancies."

Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: "At ASH (Free ASH Whitepaper), we look forward to demonstrating how pioneering science can drive meaningful advances for people living with rare haematologic conditions. New data on Ultomiris, including Phase III results in paediatric patients with HSCT-TMA, will show clinically meaningful overall survival and improved outcomes, highlighting our ongoing pursuit to realise the full potential of our medicines and their impact on treating rare conditions."

Additional highlights include:

SYRUS Phase I/II trial: Updated safety and efficacy data for surovatamig in adolescent and adult patients with R/R B-cell acute lymphoblastic leukaemia (Abstract #3345)
Phase I trial of surovatamig: Initial efficacy and safety data for surovatamig in R/R diffuse large B-cell lymphoma (Abstract #5514)
AZD0120: Follow-up data from two investigator-initiated trials (IIT) in China evaluating AZD0120 as a first-line therapy in high-risk, newly diagnosed MM (Oral Abstract #258).
TrAVeRse Phase II trial: Preliminary results evaluating Calquence plus venetoclax and rituximab in treatment-naïve MCL patients (Oral Abstract #884).
AMPLIFY Phase III trial: Exploratory analyses supporting the safety and efficacy profile of Calquence in first-line chronic lymphocytic leukaemia, with new subgroup data evaluating the impact of prognostic mutations on clinical outcomes (Poster Abstract #3898).
ALPHA Phase III trial: Sub-analysis of results evaluating Voydeya (danicopan) as add-on to Ultomiris or Soliris (eculizumab) in adults with paroxysmal nocturnal haemoglobinuria (PNH) and clinically significant extravascular haemolysis, including in patients with advanced age (Oral Abstract #949).
Ultomiris: Real-world evidence highlighting the impact of Ultomiris in certain patient subgroups across approved indications, including in pregnant patients (Poster Abstracts #6238 and #4458).
Key presentations during the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition

Lead Author

Abstract Title

Presentation Details (ET)

Awan, F et al.

Budget Impact of Fixed Duration Acalabrutinib in Combination with Venetoclax in Previously Untreated Chronic Lymphocytic Leukemia Patients in the United States

Abstract #2627

Poster Abstract Session

Session 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster I

6 December 2025
5:30 PM – 7:30 PM

Cheah, C et al.

Analysis of predictive factors for POD24 in patients with previously untreated mantle cell lymphoma receiving bendamustine-rituximab with or without acalabrutinib in the Phase 3 ECHO trial

Abstract #3578

Poster Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

7 December 2025
6:00 PM – 8:00 PM

Ghia, P et al.

Impact of prognostic mutations on outcomes with fixed-duration acalabrutinib-venetoclax combinations versus chemoimmunotherapy: An exploratory analysis from AMPLIFY

Abstract #3898

Poster Abstract Session

Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

7 December 2025
6:00 PM – 8:00 PM

Hawkes, E et al.

Acalabrutinib plus venetoclax and rituximab in patients with treatment-naive (TN) mantle cell lymphoma (MCL): Results from the phase 2 TrAVeRse study

Abstract #884

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL

8 December 2025
3:00 PM – 03:15 PM

Hou, J-Z et al.

Real-world incidence of treatment-emergent (TE) cardiovascular (CV) events among chronic lymphocytic (CLL)/small lymphocytic lymphoma (SLL) patients receiving acalabrutinib (acala) or zanubrutinib (zanu) monotherapy

Abstract #4506

Poster Abstract Session

Session 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II

7 December 2025
6:00 PM – 8:00 PM

Seymour, JF et al.

A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the Phase 3 AMPLIFY trial

Abstract #2118

Poster Abstract Session

Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

6 December 2025
5:30 PM – 7:30 PM

Wang, ML et al.

Time to third-line treatment after bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: Updated analysis of the phase 3 ECHO trial after 50 months of follow-up

Abstract #885

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL

8 December 2025
3:15 PM – 3:30 PM

Ultomiris (ravulizumab)

Schoettler, M et al.

Outcomes in pediatric patients with HSCT-TMA treated with ravulizumab

Abstract #1052

Oral Abstract Session

Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Outcomes, toxicities and late effects

8 December 2025
4:45 PM – 05:00 PM

Chaudhury, S et al.

Organ dysfunction in pediatric patients with HSCT-TMA treated with ravulizumab

Abstract #4266

Poster Abstract Session

Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Poster II

7 December 2025
6:00 PM – 8:00 PM

Sherrard, H et al.

Safety of ravulizumab use in pregnancy: Insights from a global pharmacovigilance analysis

Abstract #4458

Poster Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II

7 December 2025
6:00 PM – 8:00 PM

Gandhi, S et al.

Real-world analysis of ravulizumab safety and effectiveness in advanced age patients with paroxysmal nocturnal hemoglobinuria: Insights from the international PNH registry

Abstract #6238

Poster Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III

8 December 2025
6:00 PM – 8:00 PM

Fasenra (benralizumab)

Klion et al.

Efficacy and safety of benralizumab in patients with hypereosinophilic syndrome: Results from the Phase 3 natron study

Abstract #79

Oral Abstract Session

Session 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Expanding the Therapeutic and Prognostic Landscape in Myeloproliferative Neoplasms, Mastocytosis and Hypereosinophilic Syndrome
06 December, 2025
9:30 AM – 9:45 AM

Klion et al.

Patient perspectives on the burden of hypereosinophilic syndrome: Results from the Phase 3 natron interview sub-study

Abstract #4465

Poster Presentation

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II
07 December, 2025
6:00 PM – 8:00 PM

Voydeya (danicopan)

Kulasekararaj, A et al.

Danicopan add-on therapy demonstrates positive efficacy and safety outcomes in advanced age adults with paroxysmal nocturnal hemoglobinuria and clinically significant extravascular hemolysis: A sub-analysis of the phase 3 ALPHA trial

Abstract #949

Oral Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Antithrombotic Roulette: Balancing Risk, Cost, and Care

8 December 2025
2:45 PM – 03:00 PM

Surovatamig

Aldoss, I et al.

Safety and efficacy of surovatamig (AZD0486) in adolescent and adult patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Updated results from the Phase 1/2 SYRUS study

Abstract #3345

Poster Abstract Session

Session 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster II

7 December 2025
6:00 PM – 8:00 PM

Cheah, C et al.

SOUNDTRACK-B: A Phase 2 single-arm study to evaluate the efficacy and safety of surovatamig (AZD0486) in relapsed or refractory B-cell Non-Hodgkin lymphoma

Abstract #3747 (TiP)

Poster Abstract Session

Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster II

7 December 2025
6:00 PM – 8:00 PM

Hou, JZ et al.

Three-year follow-up of the Phase 1 first-in-human study investigating surovatamig, a novel CD19xCD3 T-cell engager, in patients with relapsed/refractory (R/R) follicular lymphoma (FL)

Abstract #1005

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological – Follicular Lymphoma

8 December 2025
5:00 PM – 5:15 PM

Kim, TM et al.

Surovatamig (AZD0486), a CD19xCD3 T-cell engager (TCE), demonstrates high rate of minimal residual disease (MRD)-negative complete responses in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including in patients who previously progressed on CD20 TCE and CD19 CAR T-cell therapies

Abstract #5514

Poster Abstract Session

Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III

8 December 2025
6:00 PM – 8:00 PM

AZD0120

Du, J et al.

A dual targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120) as first-line therapy for newly diagnosed multiple myeloma

Abstract #258

Oral Abstract Session

Session 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma

6 December 2025
2:15 PM – 2:30 PM

Richard, S et al.

Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, in relapsed/refractory multiple myeloma: Preliminary results from the DURGA-1 Phase 1b/2 study

Abstract #269

Oral Abstract Session

Session 704. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma

6 December 2025
3:00 PM – 3:15 PM

Feng, J et al.

One-year follow-up of CD19/BCMA dual-targeting FasTCAR-T GC012F (AZD0120) therapy in patients with refractory systemic lupus erythematosus

Abstract #2384

Poster Abstract Session

Session 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I

6 December 2025
5:30 PM – 7:30 PM

Lentzsch, S et al.

ALACRITY: A Phase 1b/2 Study of AZD0120 (BCMA/CD19 CAR-T cell therapy) in Participants with Relapsed or Refractory Light Chain Amyloidosis (AL)

Abstract #8236

ePublication

3 November 2025

AZD4512

Han, H et al.

AZD4512: A novel CD22-directed antibody-drug conjugate for the treatment of b-cell malignancies

Abstract #3296

Poster Abstract Session

Session 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

7 December 2025
6:00 PM – 8:00 PM

(Press release, AstraZeneca, DEC 4, 2025, View Source [SID1234661131])

On December 4, 2025 AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic CAR-T cell therapies, reported that the FDA and the European Medicines Agency (EMA) have cleared the company’s IND and approved the Clinical Trial Application (CTA), respectively, for QUADvance (AVC-203-01), a Phase II/II trial of AVC-203 for the treatment of relapsed/refractory B-cell malignancies.

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AVC-203 is a CRISPR-engineered allogeneic CAR-T candidate designed to target and eliminate cells expressing receptors CD19 and/or CD20, which are known to be expressed in nearly all B-cell malignancies.

"We are excited to build on the early success and promising activity and safety of our ongoing clinical program of allogeneic CAR-T in AML (NCT05949125) by now advancing into B Cell Lymphoma with what we believe to be the most scientifically compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell’s President & CEO. "To date, attempts at solving the key scalability and cost issues of autologous CAR-T therapy by engineering cells from unrelated donors have fallen short. Nevertheless, the obvious benefits of such an approach, including consistency and potency of an actual drug product – something in vivo approaches cannot provide – remain as compelling as ever. AvenCell remains focused on ensuring that any patient who can benefit from CAR-T therapy can receive it, through the massive scaling of supply and dramatic reductions in cost of goods, with a product that is as good or better than best-in-class autologous CAR-Ts."

About AVC-203

AVC-203 is a CRISPR-engineered allogeneic CAR-T therapy incorporating four key innovations:

Dual antigen targeting: AVC-203 CAR-T cells contain a receptor that simultaneously targets CD19 and CD20.

Immune evasion: CRISPR/Cas9 engineering enables donor cells to avoid both Graft-versus-Host Disease (GvHD) and rejection by the patient’s immune system.

Improved T-cell fitness and off-the-shelf availability: Allogeneic manufacturing from healthy donors leverages better T-cell fitness and eliminates patient-specific production, enabling immediate treatment

Switchable targeting: A RevCAR receptor dimerized to the CD19/CD20 CAR enables flexible targeting of additional tumor antigens through bi- or tri-specific bridging proteins, allowing future target expansion beyond CD19/CD20.
Trial Designs and Objectives

The phase I/II study will be conducted at multiple sites in the US and Europe and will evaluate the safety, tolerability, efficacy, and pharmacokinetics of AVC-203 in adults with relapsed or refractory B-cell malignancies. The phase Ia dose escalation study is expected to be followed by a phase Ib dose expansion study and a Phase II pivotal trial.

B-cell malignancies

B-cell malignancies — including non-Hodgkin lymphomas, multiple myeloma, and B-cell acute lymphoblastic leukemia (B-ALL) — account for the majority of blood cancers. Approximately 120,000 and 150,000 new cases are diagnosed annually in the United States and Europe, respectively.

(Press release, AvenCell Therapeutics, DEC 4, 2025, View Source;302632517.html [SID1234661145])

On December 4, 2025 AstraZeneca reported its ambition to redefine haematology care with new data from its diverse pipeline and portfolio at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, 6-9 December 2025.

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!

This year’s ASH (Free ASH Whitepaper) congress will feature the Company’s largest presence to date, with 65 abstracts across eight approved and investigational medicines, including 15 oral presentations.

Key presentations include:

Phase I trial of surovatamig: Updated results at three-year follow up from the ongoing first-in-human trial of surovatamig, a CD19xCD3 T-cell engager, in relapsed/refractory (R/R) follicular lymphoma (FL) (Oral Abstract #1005).
DURGA-1 Phase Ib/II study: Initial data for AZD0120 in patients with R/R multiple myeloma (MM). AZD0120 is an investigational BCMAxCD19 chimeric antigen receptor T-cell (CAR T) therapy (Oral Abstract #269).
ECHO Phase III trial: Results after 50 months of follow up evaluating Calquence (acalabrutinib) plus bendamustine and rituximab in the first-line treatment of mantle cell lymphoma (MCL) (Oral Abstract #885).
ALXN1210-TMA-314 Phase III trial: Additional results from the open-label trial evaluating Ultomiris (ravulizumab) in paediatric patients with haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) (Oral Abstract #1052).
Anas Younes, Senior Vice President, Haematology R&D and Chief Medical Officer, AstraZeneca, said: "We are advancing a broad pipeline of investigational therapies with the potential to redefine patient care across multiple types of blood cancer. At ASH (Free ASH Whitepaper), we are sharing meaningful progress with early efficacy and safety data for AZD0120, our first cell therapy, in multiple myeloma, and for surovatamig, a novel T-cell engager, in B-cell malignancies."

Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: "At ASH (Free ASH Whitepaper), we look forward to demonstrating how pioneering science can drive meaningful advances for people living with rare haematologic conditions. New data on Ultomiris, including Phase III results in paediatric patients with HSCT-TMA, will show clinically meaningful overall survival and improved outcomes, highlighting our ongoing pursuit to realise the full potential of our medicines and their impact on treating rare conditions."

Additional highlights include:

SYRUS Phase I/II trial: Updated safety and efficacy data for surovatamig in adolescent and adult patients with R/R B-cell acute lymphoblastic leukaemia (Abstract #3345)
Phase I trial of surovatamig: Initial efficacy and safety data for surovatamig in R/R diffuse large B-cell lymphoma (Abstract #5514)
AZD0120: Follow-up data from two investigator-initiated trials (IIT) in China evaluating AZD0120 as a first-line therapy in high-risk, newly diagnosed MM (Oral Abstract #258).
TrAVeRse Phase II trial: Preliminary results evaluating Calquence plus venetoclax and rituximab in treatment-naïve MCL patients (Oral Abstract #884).
AMPLIFY Phase III trial: Exploratory analyses supporting the safety and efficacy profile of Calquence in first-line chronic lymphocytic leukaemia, with new subgroup data evaluating the impact of prognostic mutations on clinical outcomes (Poster Abstract #3898).
ALPHA Phase III trial: Sub-analysis of results evaluating Voydeya (danicopan) as add-on to Ultomiris or Soliris (eculizumab) in adults with paroxysmal nocturnal haemoglobinuria (PNH) and clinically significant extravascular haemolysis, including in patients with advanced age (Oral Abstract #949).
Ultomiris: Real-world evidence highlighting the impact of Ultomiris in certain patient subgroups across approved indications, including in pregnant patients (Poster Abstracts #6238 and #4458).
Key presentations during the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition

Lead Author

Abstract Title

Presentation Details (ET)

Awan, F et al.

Budget Impact of Fixed Duration Acalabrutinib in Combination with Venetoclax in Previously Untreated Chronic Lymphocytic Leukemia Patients in the United States

Abstract #2627

Poster Abstract Session

Session 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster I

6 December 2025
5:30 PM – 7:30 PM

Cheah, C et al.

Analysis of predictive factors for POD24 in patients with previously untreated mantle cell lymphoma receiving bendamustine-rituximab with or without acalabrutinib in the Phase 3 ECHO trial

Abstract #3578

Poster Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

7 December 2025
6:00 PM – 8:00 PM

Ghia, P et al.

Impact of prognostic mutations on outcomes with fixed-duration acalabrutinib-venetoclax combinations versus chemoimmunotherapy: An exploratory analysis from AMPLIFY

Abstract #3898

Poster Abstract Session

Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

7 December 2025
6:00 PM – 8:00 PM

Hawkes, E et al.

Acalabrutinib plus venetoclax and rituximab in patients with treatment-naive (TN) mantle cell lymphoma (MCL): Results from the phase 2 TrAVeRse study

Abstract #884

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL

8 December 2025
3:00 PM – 03:15 PM

Hou, J-Z et al.

Real-world incidence of treatment-emergent (TE) cardiovascular (CV) events among chronic lymphocytic (CLL)/small lymphocytic lymphoma (SLL) patients receiving acalabrutinib (acala) or zanubrutinib (zanu) monotherapy

Abstract #4506

Poster Abstract Session

Session 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II

7 December 2025
6:00 PM – 8:00 PM

Seymour, JF et al.

A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the Phase 3 AMPLIFY trial

Abstract #2118

Poster Abstract Session

Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

6 December 2025
5:30 PM – 7:30 PM

Wang, ML et al.

Time to third-line treatment after bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: Updated analysis of the phase 3 ECHO trial after 50 months of follow-up

Abstract #885

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL

8 December 2025
3:15 PM – 3:30 PM

Ultomiris (ravulizumab)

Schoettler, M et al.

Outcomes in pediatric patients with HSCT-TMA treated with ravulizumab

Abstract #1052

Oral Abstract Session

Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Outcomes, toxicities and late effects

8 December 2025
4:45 PM – 05:00 PM

Chaudhury, S et al.

Organ dysfunction in pediatric patients with HSCT-TMA treated with ravulizumab

Abstract #4266

Poster Abstract Session

Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Poster II

7 December 2025
6:00 PM – 8:00 PM

Sherrard, H et al.

Safety of ravulizumab use in pregnancy: Insights from a global pharmacovigilance analysis

Abstract #4458

Poster Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II

7 December 2025
6:00 PM – 8:00 PM

Gandhi, S et al.

Real-world analysis of ravulizumab safety and effectiveness in advanced age patients with paroxysmal nocturnal hemoglobinuria: Insights from the international PNH registry

Abstract #6238

Poster Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III

8 December 2025
6:00 PM – 8:00 PM

Fasenra (benralizumab)

Klion et al.

Efficacy and safety of benralizumab in patients with hypereosinophilic syndrome: Results from the Phase 3 natron study

Abstract #79

Oral Abstract Session

Session 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Expanding the Therapeutic and Prognostic Landscape in Myeloproliferative Neoplasms, Mastocytosis and Hypereosinophilic Syndrome
06 December, 2025
9:30 AM – 9:45 AM

Klion et al.

Patient perspectives on the burden of hypereosinophilic syndrome: Results from the Phase 3 natron interview sub-study

Abstract #4465

Poster Presentation

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II
07 December, 2025
6:00 PM – 8:00 PM

Voydeya (danicopan)

Kulasekararaj, A et al.

Danicopan add-on therapy demonstrates positive efficacy and safety outcomes in advanced age adults with paroxysmal nocturnal hemoglobinuria and clinically significant extravascular hemolysis: A sub-analysis of the phase 3 ALPHA trial

Abstract #949

Oral Abstract Session

Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Antithrombotic Roulette: Balancing Risk, Cost, and Care

8 December 2025
2:45 PM – 03:00 PM

Surovatamig

Aldoss, I et al.

Safety and efficacy of surovatamig (AZD0486) in adolescent and adult patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Updated results from the Phase 1/2 SYRUS study

Abstract #3345

Poster Abstract Session

Session 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster II

7 December 2025
6:00 PM – 8:00 PM

Cheah, C et al.

SOUNDTRACK-B: A Phase 2 single-arm study to evaluate the efficacy and safety of surovatamig (AZD0486) in relapsed or refractory B-cell Non-Hodgkin lymphoma

Abstract #3747 (TiP)

Poster Abstract Session

Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster II

7 December 2025
6:00 PM – 8:00 PM

Hou, JZ et al.

Three-year follow-up of the Phase 1 first-in-human study investigating surovatamig, a novel CD19xCD3 T-cell engager, in patients with relapsed/refractory (R/R) follicular lymphoma (FL)

Abstract #1005

Oral Abstract Session

Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological – Follicular Lymphoma

8 December 2025
5:00 PM – 5:15 PM

Kim, TM et al.

Surovatamig (AZD0486), a CD19xCD3 T-cell engager (TCE), demonstrates high rate of minimal residual disease (MRD)-negative complete responses in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including in patients who previously progressed on CD20 TCE and CD19 CAR T-cell therapies

Abstract #5514

Poster Abstract Session

Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III

8 December 2025
6:00 PM – 8:00 PM

AZD0120

Du, J et al.

A dual targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120) as first-line therapy for newly diagnosed multiple myeloma

Abstract #258

Oral Abstract Session

Session 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma

6 December 2025
2:15 PM – 2:30 PM

Richard, S et al.

Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, in relapsed/refractory multiple myeloma: Preliminary results from the DURGA-1 Phase 1b/2 study

Abstract #269

Oral Abstract Session

Session 704. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma

6 December 2025
3:00 PM – 3:15 PM

Feng, J et al.

One-year follow-up of CD19/BCMA dual-targeting FasTCAR-T GC012F (AZD0120) therapy in patients with refractory systemic lupus erythematosus

Abstract #2384

Poster Abstract Session

Session 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I

6 December 2025
5:30 PM – 7:30 PM

Lentzsch, S et al.

ALACRITY: A Phase 1b/2 Study of AZD0120 (BCMA/CD19 CAR-T cell therapy) in Participants with Relapsed or Refractory Light Chain Amyloidosis (AL)

Abstract #8236

ePublication

3 November 2025

AZD4512

Han, H et al.

AZD4512: A novel CD22-directed antibody-drug conjugate for the treatment of b-cell malignancies

Abstract #3296

Poster Abstract Session

Session 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

7 December 2025
6:00 PM – 8:00 PM

(Press release, AstraZeneca, DEC 4, 2025, View Source [SID1234661131])