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Novartis data underscore pioneering scientific innovation in Hematology and Oncology at ASH and SABCS

On November 25, 2025 Novartis reported it will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.

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"For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH (Free ASH Whitepaper) and SABCS," said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. "These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients."

Key highlights of data accepted by ASH (Free ASH Whitepaper) include:

Abstract Title Abstract Number/ Presentation Details
Ianalumab (VAY736)
Primary results from VAYHIT2, a randomized, double-blind, Phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatment Abstract #LBA-2
Oral Presentation
December 9, 7:45 – 8:00 am ET
Secondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy Abstract #844
Oral Presentation
December 8, 3:30 – 3:45 pm ET
Scemblix (asciminib)
Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis Abstract #1997
Poster Presentation
December 6, 5:30 – 7:30 pm ET
Improved long-term tolerability with asciminib (ASC) vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Week 96 exploratory analysis of the phase 3 ASC4FIRST trial Abstract #5549
Poster Presentation
December 8, 6:00 – 8:00 pm ET
Asciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of patients (pts) with 1 prior tyrosine kinase inhibitor (TKI) Abstract #906
Oral Presentation
December 8, 4:00 – 4:15 pm ET
A comparison of real-world outcomes of asciminib versus ATP-competitive tyrosine kinase inhibitors as second-line treatment in patients with chronic myeloid leukemia in chronic phase Abstract #724
Oral Presentation
December 7, 5:15 – 5:30 pm ET
Pelabresib (DAK539)
Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 study Abstract #910
Oral Presentation
December 8, 3:30 – 3:45pm ET
Rapcabtagene autoleucel (YTB323)
Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim results Abstract #670
Oral Presentation
December 7, 5:15 – 5:30 pm ET
Fabhalta (iptacopan)
Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin increases in patients with paroxysmal nocturnal hemoglobinuria with baseline hemoglobin levels 10 to <12 g/dL on anti-C5 therapy: Subgroup analysis of the APPULSE-PNH Phase 3b trial Abstract #4981
Poster Presentation
December 8, 6:00 – 8:00 pm ET
Long-term safety and efficacy of iptacopan in patients with paroxysmal nocturnal hemoglobinuria: 4- and 5-year follow-up of patients from phase 2 studies who entered the roll-over extension program Abstract #3198
Poster Presentation
December 7, 6:00 – 8:00 pm ET
The 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension program Abstract #4978
Poster Presentation
December 8, 6:00 – 8:00 pm ET

Key highlights of data accepted by SABCS include:

Kisqali (ribociclib)
Pooled analysis of patients (pts) treated with 1st-line (1L) ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) studies: long-term progression-free survival (PFS) Abstract # PD5-10
Poster Spotlight Presentation
December 11, 8:09 – 8:12 am CST
Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC) Abstract # PS3-09-08
Poster Presentation
December 11, 12:30 – 2:00 pm CST
Progression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) Abstract # PS1-10-27
Poster Presentation
December 10, 12:30 – 2:00 pm CST
Ribociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patients Abstract # PS3-09-15
Poster Presentation
December 11, 12:30 – 2:00 pm CST
Real-world patient (pt) and caregiver experiences with breast cancer (BC) risk of recurrence (ROR) in the US: Results of an Online Survey and Social Media Analysis Abstract # PS1-04-17
Poster Presentation
December 10, 12:30 – 2:00 pm CST
Repower: a real-world noninterventional study of outcomes and experiences in patients with hormone receptor-positive (HR+)/human epidermal growth fact receptor 2-negative (HER2−) early breast cancer (EBC) treated with an adjuvant cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) plus endocrine therapy (ET) Abstract # PS3-08-27
Poster Presentation
December 11, 12:30 – 2:00 pm CST

(Press release, Novartis, NOV 25, 2025, View Source [SID1234660913])

PharmaEssentia Announces Publication of Phase 3 SURPASS-ET Results in The Lancet Haematology

On November 24, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that positive results from its pivotal Phase 3 SURPASS-ET clinical trial (NCT04285086) have been published in The Lancet Haematology.

The paper, titled "Ropeginterferon alfa-2b in hydroxyurea-intolerant or hydroxyurea-refractory essential thrombocythaemia (SURPASS ET): a multicentre, open-label, randomised, active-controlled, phase 3 study," highlights the potential of ropeginterferon alfa-2b-njft as a new therapeutic option for patients with essential thrombocythemia (ET). ET is a chronic myeloproliferative neoplasm (MPN) characterized by uncontrolled platelet production and an elevated risk of blood clots, bleeding events and progression to more serious cancers. There have been no new treatments approved in the United States for ET since anagrelide in 1997, underscoring the need for new innovative therapies.

SURPASS-ET compared ropeginterferon alfa-2b with anagrelide in patients with ET with leukocytosis who were resistant or intolerant to hydroxyurea. Data showed that ropeginterferon alfa-2b achieved statistically superior responses, with 43% of patients demonstrating durable responses at months 9 and 12 (as defined by modified ELN criteria) compared with 6% of those receiving anagrelide.

Beyond the primary endpoint, ropeginterferon alfa-2b demonstrated more robust hematologic responses, greater symptom improvement, improved control of splenomegaly, fewer thromboembolic events and deeper molecular responses across key patient subgroups. Notably, treatment with ropeginterferon alfa-2b resulted in significant reductions in JAK2 V617F allele burden, an important indicator of potential disease-modifying activity in MPNs. The therapy was also well tolerated, with no major cardiac or neurological events and lower rates of significant adverse events and treatment discontinuations relative to anagrelide.

"The SURPASS-ET data are impressive and demonstrate not only durable clinical and symptomatic benefits with ropeginterferon alfa-2b, but also reductions in JAK2 V617F allele burden—an important marker associated with potential disease modification," said Ruben Mesa, MD, lead author of the publication, principal investigator of the SURPASS-ET trial and President of Advocate Health’s Cancer National Service Line, which includes Atrium Health Levine Cancer Institute and the Comprehensive Cancer Center at Atrium Health Wake Forest Baptist. "ET remains a challenging chronic disease, and patients who are resistant or intolerant to hydroxyurea have had few alternatives for sustained disease control. After nearly three decades without new therapeutic options, these findings represent a promising step forward for patients and clinicians."

"We are encouraged to see the SURPASS-ET results recognized in a leading peer-reviewed journal," said Ko-Chung Lin, PhD, Founder and Chief Executive Officer of PharmaEssentia. "Ropeginterferon alfa-2b-njft has already reshaped the treatment landscape for polycythemia vera, and the findings from this study further reinforce its potential to benefit patients across the MPN spectrum. We look forward to advancing our regulatory efforts to bring this therapy to individuals living with ET, supporting the potential to expand our commercialization efforts in this new indication in 2026, pending FDA approval."

(Press release, PharmaEssentia, NOV 24, 2025, View Source [SID1234660925])

Janux Therapeutics to Host Virtual Event Discussing Updated Phase 1a and Phase 1b Clinical Data for JANX007 in mCRPC

On November 24, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported it will host a virtual event on Monday, December 1, 2025, at 4:30 PM ET.

David Campbell, Ph.D., President & Chief Executive Officer will provide an update on JANX007 primarily focused on Phase 1a dose escalation data and secondarily on Phase 1b expansion data in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

A live analyst question and answer session will follow the formal presentation. To register for the event, please click here.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

(Press release, Janux Therapeutics, NOV 24, 2025, View Source [SID1234660924])

Kelonia Therapeutics Announces Late-Breaking Oral Presentation of First-in-Human Data from in vivo BCMA CAR-T Therapy at the American Society of Hematology (ASH) 2025 Annual Meeting

On November 24, 2025 Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene delivery, reported that its first results from the ongoing inMMyCAR study, a Phase 1 clinical trial evaluating KLN-1010, a novel in vivo gene therapy that generates anti-BCMA CAR-T cells in patients with relapsed and refractory multiple myeloma, will be presented in a late-breaking oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting in Orlando, Florida.

The late-breaking abstract features results from the first three patients treated with KLN-1010. All patients achieved minimal residual disease (MRD) negativity at month 1 that persisted through three months in the patient with the longest follow up. CAR-T cell expansion and persistence of memory CAR-T cells occurred without the use of lymphodepleting chemotherapy, apheresis, or ex vivo cell manufacturing.

"KLN-1010 is beginning to show the extraordinary clinical outcomes that may be possible with in vivo CAR-T therapy — early, deep responses from a single infusion without the barriers that limit access to traditional CAR-T treatments," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "These initial data point to a potentially powerful medicine while also providing clear clinical validation of our iGPS platform; enabling a growing number of partnered programs as well as our wholly owned pipeline that includes KLN-1010. We are encouraged by these first-in-human results and looking forward to sharing additional details from the study with the scientific and medical communities at the ASH (Free ASH Whitepaper) Annual Meeting."

"In these early patients, we are seeing both rapid MRD-negative responses and persistent memory-phenotype CAR-T cells, a combination that has been strongly prognostic for durable clinical benefit with existing CAR-T approaches," said Simon Harrison, MBBS, MRCP(UK), FRCPath(UK), FRACP, Ph.D., Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre and lead author of the late-breaking abstract. "Achieving these outcomes without lymphodepleting chemotherapy or CAR-T cell manufacturing underscores the potential of this in vivo approach to fundamentally expand access to CAR-T therapy for patients with relapsed and refractory multiple myeloma."

Oral Presentation Details:

Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human Phase 1 study of KLN-1010

Date: Tuesday, December 9, 2025, 7:30 – 9:00 AM EST

Location: West Hall D2 (Orange County Convention Center)

Session Title: Late-Breaking Abstracts Session

About inMMyCAR

inMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. KLN-1010 has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). This Phase 1 clinical trial marks the first time KLN‑1010 will be evaluated in humans. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).

About Relapsed and Refractory Multiple Myeloma

Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.

About KLN-1010

KLN‑1010 is an investigational in vivo gene therapy that generates anti-BCMA CAR-T cells, targeting a protein expressed on the surface of multiple myeloma cells. Unlike traditional CAR‑T treatments, KLN‑1010 is administered to patients via direct transfusion and is designed to generate durable CAR‑T cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and preconditioning chemotherapy.

(Press release, Kelonia Therapeutics, NOV 24, 2025, View Source [SID1234660923])

Artera Unveils Data Demonstrating Prognostic and Predictive Utility in Breast Cancer at SABCS 2025

On November 24, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported that three abstracts will be presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12.

The studies collectively highlight the prognostic and predictive power of Artera’s MMAI model to help personalize treatment decisions, particularly in evaluating chemotherapy benefit in post-menopausal women. Leveraging data from four independent Phase III trials across Germany, Austria, and North America, these studies validate the performance of this unique AI model across more than 7,000 patients.

"These abstracts hold tremendous weight as they cover a diverse set of patients with HR+ early breast cancer, giving clinicians a lot of confidence in the validity of these results," said Prof. Nadia Harbeck, Director of the Breast Center at LMU University Hospital in Munich, Germany. "Traditional approaches can result in patients, especially those who are post-menopausal with node-negative tumors, receiving chemotherapy with limited benefit while still facing significant toxicities. It’s exciting to witness the emergence of new technologies that allow us to deliver the optimal breast cancer care."

Approximately 1 in 8 women (13%) in the U.S. will develop invasive breast cancer at some point in their lives, and many face complex treatment decisions. Chemotherapy carries well‑documented side effects, including neuropathy, risk of infection, and, for younger women especially, infertility and impaired fertility potential. These risks underscore the need for tools that help clinicians tailor treatment decisions, ensuring each patient receives care that is necessary, appropriate, and aligned with their unique clinical profile.

"Advancing precision medicine means ensuring every patient can benefit from individualized care," said Andre Esteva, CEO of Artera. "As we validate this technology across countries and cancer types, we’re showing that precision medicine can be more personalized and accessible while helping clinicians avoid unnecessary treatments without added time, cost, or complex processes."

Presentations at SABCS 2025

Poster Spotlight 11 (PD11-01) Development of a Multi-Modal Artificial Intelligence (MMAI) Model for Predicting Distant Metastasis in HR+ Early-Stage Invasive Breast Cancer (Abstract #1251)

Demonstrates the development of Artera’s MMAI model using data from over 12,000 patients enrolled in six Phase III clinical trials conducted in the United States, Germany, and Austria. The model effectively stratifies patients by 10-year risk of distant metastasis, identifying high-risk individuals who may benefit from closer monitoring, while 68% of patients were classified as low-risk and achieved an estimated 10-year DM-free survival of approximately 95%. These findings show the model’s potential to provide actionable prognostic information across diverse, international populations.

Poster Session 3 (PS3-04-08) Independent Validation of a Pathology-Based Multimodal Artificial Intelligence Biomarker for Predicting Risk of Distant Metastasis in Postmenopausal, Estrogen Receptor-Positive, Early-Stage Breast Cancer Patients: Analysis of the ABCSG Trial 8 (Abstract #1410)

Focuses on postmenopausal patients in the ABCSG 8 trial, a prospective study of individuals receiving endocrine therapy only. MMAI successfully classified patients into low, intermediate, and high-risk groups, with corresponding 10-year DM-free survival rates of roughly 95%, 89%, and 77%, respectively. Validation confirmed robust performance across clinical subgroups, including lymph node status, tumor grade, histology, and proliferation markers. The study further highlights the advantages of MMAI as a non-tissue-destructive, fast-turnaround test, providing an accessible alternative to more costly genomic assays.

Rapid Fire 3 (RF3-03) Evaluation of a digital pathology-based multimodal artificial intelligence model for prognosis and prediction of chemotherapy benefit in node-negative, hormone receptor-positive breast cancer patients: analysis of the NSABP B-20 trial. (Abstract #3685)

Evaluates MMAI’s ability to predict benefit from chemotherapy in node-negative HR+ patients in the NSABP B-20 trial. Among patients aged 50 and older, MMAI high-risk individuals experienced a 52% relative reduction in 10-year DM with chemotherapy, while MMAI low-risk patients derived no additional benefit. These findings demonstrate MMAI’s potential to guide personalized treatment decisions, helping clinicians avoid unnecessary chemotherapy for low-risk patients while identifying high-risk patients who are most likely to benefit.

Artera will be exhibiting at booth #1525 during SABCS, where attendees can learn more about the MMAI platform and the ArteraAI Breast Test.

(Press release, Artera, NOV 24, 2025, View Source [SID1234660922])