On December 8, 2025 Daiichi Sankyo (TSE: 4568) reported it will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU (trastuzumab deruxtecan) and DATROWAY (datopotamab deruxtecan) across a broad spectrum of breast cancer.

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Four rapid fire mini-oral sessions will feature ENHERTU data in the curative-intent and metastatic settings of HER2 positive breast cancer, including two presentations from the DESTINY-Breast11 phase 3 trial highlighting patient reported outcomes (RF6-06) and further safety analyses (RF6-02) of ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Additional efficacy and safety data (RF6-01) from the DESTINY-Breast05 phase 3 trial comparing ENHERTU to trastuzumab emtansine (T-DM1) as a post-neoadjuvant (after surgery) therapy in patients with high-risk HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes also will be highlighted.

The fourth rapid fire presentation will feature patient reported outcomes (RF6-07) from the ENHERTU plus pertuzumab arm of the DESTINY-Breast09 phase 3 trial as a first-line treatment of HER2 positive metastatic breast cancer. Interim results from DESTINY-Breast09 were recently published in The New England Journal of Medicine, marking the eighth pivotal trial of ENHERTU to be published in the prestigious journal.

Additional updates from two other landmark breast cancer trials include poster presentations featuring the final analysis and five-year follow-up of efficacy and safety data (PS5-01-30) from the DESTINY-Breast03 phase 3 trial comparing ENHERTU versus T-DM1 as a second-line treatment of HER2 positive metastatic breast cancer, and further safety analysis (PS5-03-05) from the TROPION-Breast02 phase 3 trial of DATROWAY, the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option.

"Our latest research across these five landmark trials demonstrate how the DXd antibody drug conjugate portfolio of Daiichi Sankyo continues to potentially transform standards of care for patients with breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We remain committed to following the science and collaborating with the breast cancer community to create innovative medicines that advance the treatment of breast cancer."

Additional data from the DESTINY clinical trial program to be highlighted in poster presentations at SABCS include an exploratory post-hoc subgroup analysis by hormone receptor status from the DESTINY-Breast12 phase 3b/4 trial (PS5-01-27) of ENHERTU in patients with HER2 positive metastatic breast cancer and brain metastases; the final results from the ENHERTU monotherapy and ENHERTU plus pertuzumab arms of the DESTINY-Breast07 phase 1b/2 trial (PS5-01-14) in patients with previously untreated HER2 positive metastatic breast cancer; and, initial characteristics of first enrolled patients from the DESTINY Breast Respond HER2 Low Europe non-interventional study (PS5-08-14) of ENHERTU in HER2 low metastatic breast cancer.

Collaborations Supporting Innovation in Breast Cancer Research
Additional data presented at SABCS include results from four externally sponsored trials across the DXd ADC pipeline of Daiichi Sankyo. Two spotlight poster presentations will report interim results from the HALLOW prospective observational trial (PD13-11) evaluating the efficacy and safety of ENHERTU in patients with HER2 low (IHC 1+ or 2+/ISH-) metastatic breast cancer with and without active brain metastases in Japan, and a post-hoc pooled efficacy analysis (PD13-10) from the TUXEDO-3 phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and active brain metastases or leptomeningeal disease previously treated with ENHERTU. Results from cohorts 1 and cohorts 2 of the TUXEDO-3 trial were recently published in The Lancet Oncology and results from cohort 3 were published in Nature Medicine.

Two poster presentations will report on the intracranial and/or extracranial activity of ENHERTU and DATROWAY. A translational ctDNA analysis of intracranial and extracranial activity (PS2-08-20) of ENHERTU from the DEBBRAH phase 2 trial in patients with HER2 positive and HER2 low breast cancer with leptomeningeal disease will be highlighted, as well as results of intracranial activity (PS1-09-02) of DATROWAY from the DATO-BASE phase 2 trial in patients with HER2 negative breast cancer with leptomeningeal disease.

Trials-in-Progress Across Breast Cancer Portfolio of Daiichi Sankyo
Several trials-in-progress poster presentations at SABCS further highlight research underway to address a broad spectrum of unmet needs for patients with breast cancer.

Additional externally sponsored trials for ENHERTU and DATROWAY include the PONTIAC phase 2 trial (PS5-07-15) evaluating ENHERTU versus CDK4/6 inhibitor-based endocrine therapy as a first-line treatment of non-luminal HR positive, HER2 low and HER2 ultralow advanced breast cancer; a phase 1b trial (PS5-09-22) evaluating ENHERTU in combination with valemetostat, an EZH1/2 inhibitor, in patients with HER2 low, HER2 ultralow and HER2 null metastatic breast cancer; and the TROPION-Breast06 phase 3b trial (PS5-07-21) of DATROWAY in patients with HR positive, HER2 IHC 0 inoperable or metastatic breast cancer refractory to endocrine therapy.

Three additional trials-in-progress from the HERTHENA clinical development program of patritumab deruxtecan (HER3-DXd) also will be highlighted. These include the HERTHENA-Breast04 phase 3 trial (PS5-07-22) evaluating patritumab deruxtecan versus physician’s choice of treatment in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; the HERTHENA-Breast03 phase 2 trial (PS5-12-21) evaluating neoadjuvant patritumab deruxtecan plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; and, the HERTHENA-Breast01 phase 1b/2 trial (PS5-12-23) evaluating patritumab deruxtecan in combination with HER2 targeted agents in patients with HER2 positive unresectable locally advanced or metastatic breast cancer.

Science & Technology Day
Daiichi Sankyo will hold its annual Science & Technology Day for investors on Monday, December 15, 2025, from 5:30 to 7:30 pm ET / Tuesday, December 16, 2025, from 7:30 – 9:30 am JST. Executives from Daiichi Sankyo will provide an update on R&D, business and manufacturing developments across the portfolio.

Daiichi Sankyo Presentation Highlights at SABCS

Presentation Title

Author

Abstract

Presentation (CST)

ENHERTU (trastuzumab deruxtecan; T-DXd)

Patient-reported outcomes in DESTINY-Breast11: neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer

S. Modi

RF6-06

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

DESTINY-Breast11 safety: neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer

G. Curigliano

RF6-02

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Additional efficacy and safety from the DESTINY-Breast05 study of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T‑DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary early breast cancer with residual invasive disease after neoadjuvant therapy

S. Loibl

RF6-01

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with HER2 positive (HER2+) advanced/metastatic breast cancer: patient-reported outcomes from the DESTINY-Breast09 study

M. Rimawi

RF6-07

Rapid Fire 6
Mini-Oral Session
Wednesday, December 10
1:00 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer: final analysis from DESTINY-Breast03

S. Im

PS5-01-30

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ unresectable/metastatic breast cancer: final results from DESTINY-Breast07

F. Andre

PS5-01-14

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Outcomes by hormone receptor status in patients with HER2+ advanced/metastatic breast cancer with brain metastases treated with trastuzumab deruxtecan (T-DXd): a post-hoc subgroup analysis of DESTINY-Breast12

H. Wildiers

PS5-01-27

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

DESTINY-Breast Respond HER2 low Europe: description of first enrolled patients in the non-interventional study of T-DXd in HER2 low metastatic breast cancer

V. Guarneri

PS5-08-14

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Interim analysis results for the effectiveness and safety of trastuzumab deruxtecan in patients with HER2 low breast cancer and brain metastases: the HALLOW study

N. Niikura

PD13-11

Poster Spotlight 13
Friday, December 12
7:00 – 8:30 am

Translational analysis of cerebrospinal fluid and plasma circulating tumor DNA from breast cancer patients with leptomeningeal disease treated with trastuzumab deruxtecan (T-DXd) in the DEBBRAH trial

A. Fitzpatrick

PS2-08-20

Poster Session 2
Wednesday, December 10
5:00 – 6:30 pm

Trials-in-Progress

A randomized phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of hormone receptor-positive and HER2 low/ultralow advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling: the PONTIAC study

J. Cortes

PS5-07-15

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultralow/null metastatic breast cancer

S. Damodaran

PS5-09-22

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

DATROWAY (datopotamab deruxtecan; Dato-DXd)

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option: additional safety analyses from the TROPION-Breast02 study

T. Traina

PS5-03-05

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

Intracranial activity of datopotamab deruxtecan (Dato-DXd) for patients with HER2 negative breast cancer and leptomeningeal disease: results from cohort C of the DATO-Base phase 2 trial

P. Tarantino

PS1-09-02

Poster Session 1
Wednesday, December 10
12:30 – 2:00 pm

Trials-in-Progress

TROPION-Breast06: multicenter, multinational, open-label, single-arm, phase 3b study of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced inoperable or metastatic HR+/HER2 IHC 0 breast cancer refractory to endocrine therapy

K. Jhaveri

PS5-07-21

Poster Session 5
Friday, December 12
12:30 – 2:30 pm

Patritumab Deruxtecan (HER3-DXd)

Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and CNS involvement previously treated with T-DXd: a subanalysis of TUXEDO-3

R. Bartsch

PD13-10

Poster Spotlight 13
Friday, December 12
7:00 – 8:30 am

Trials-in-Progress

HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer

B. Pistilli

PS5-07-22

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer

J. O’Shaughnessy

PS5-12-21

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

HERTHENA-Breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

S. Tolaney

PS5-12-23

Poster Session 5
Friday, December 12
12:30 – 2:00 pm

(Press release, Daiichi Sankyo, DEC 8, 2025, https://www.businesswire.com/news/home/20251208780034/en/Daiichi-Sankyo-Showcases-Strength-of-Industry-Leading-ADC-Portfolio-with-Latest-Research-Updates-from-Five-Landmark-Breast-Cancer-Trials-at-SABCS [SID1234661296])

On December 8, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, reported seven abstracts have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) 2025, taking place from December 9–12, 2025, in San Antonio, Texas. The research, conducted in collaboration with leading cancer centers, demonstrates the power of the BostonGene platform to uncover complex breast cancer tumor biology and drive informed, personalized treatment strategies. BostonGene will exhibit at booth #1352.

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Poster spotlight discussions:

Poster spotlight number: PD7-03
Title: Circulating immune correlates of pathological response to neoadjuvant pembrolizumab plus chemotherapy in high-risk, early-stage triple-negative breast cancer
Date & time: December 11, 2025; 7:36 AM – 7:39 AM
Presenter: Clinton Yam, MD, MS, The University of Texas MD Anderson Cancer Center

Using BostonGene’s multi-parameter immune phenotyping platform and immunotype signature scores, clinicians at MD Anderson profiled peripheral blood from patients with triple-negative breast cancer (TNBC) undergoing the KEYNOTE-522 regimen. This study showed immune cells in the blood were significantly associated with improved response to KEYNOTE-522. Identified through BostonGene’s natively omnimodal AI model, these immune signatures show promise as minimally invasive biomarkers to identify patients most likely to respond to immune-based neoadjuvant approaches, supporting patient stratification and optimization of therapy in TNBC.

Research done in collaboration with MD Anderson Cancer Center

Poster spotlight number: PD7-09
Title: Feasibility of a machine learning (ML)-based peripheral blood immunoprofiling platform to stratify patients (pts) with early-stage triple-negative breast cancer
Date & time: December 11, 2025; 8:06 AM – 8:09 AM
Presenter: Chiara Corti, MD, Dana-Farber Cancer Institute

BostonGene’s machine learning-based immune phenotyping platform was used to examine blood samples of early-stage triple-negative breast cancer (TNBC). BostonGene’s platform assessed how immune profiles differed between chemotherapy alone and chemotherapy plus immunotherapy, and how they evolved during treatment. Immunotype distribution varied significantly by therapy type and showed dynamic changes, particularly in patients receiving chemo-immunotherapy. These findings support the feasibility of capturing immune dynamics in peripheral blood as a minimally invasive approach to refine patient stratification, improve trial design and inform treatment optimization in early-stage TNBC.

Research done in collaboration with Brigham and Women’s Hospital

Poster presentations:

Presentation number: PS1-09-12
Title: TROP2 expression and therapeutic opportunities in inflammatory breast cancer
Date & time: December 10, 2025; 12:30 PM – 2:00 PM
Presenter: Shayla Murray, MD Anderson Cancer Center

Collaborative research utilizing BostonGene’s foundation AI platform revealed that TROP2 RNA expression alone does not predict antibody-drug conjugate response in inflammatory breast cancers, underscoring the limitations of single-marker approaches. These findings demonstrate the necessity of BostonGene’s AI-driven omnimodal analysis built to uncover complex tumor biology and optimize clinical trial design for next-generation precision oncology therapies.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-10-30
Title: Tumor-associated macrophage (TAMs) and cancer-associated fibroblasts (CAFs) profiles in invasive lobular carcinoma (ILC) vs no special type (NST)
Date & time: December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Jason Mouabbi, MD, MD Anderson Cancer Center

BostonGene performed a large-scale analysis of 617 ILC and NST breast cancers, leveraging its AI-driven KassandraTM algorithm to deconvolve hundreds of cell subtypes and activation states from RNA data within the tumor microenvironment (TME). Similar to NST, ILC samples harbored immunosuppressive, stroma-rich TMEs dominated by FAP⁺ myofibroblastic CAFs and M1/M2 TAMs, identifying previously unknown opportunities for targeted therapeutics and novel immune strategies in this often understudied cancer.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-10-16
Title: Distinct immune landscapes in inflammatory and metaplastic breast cancer: Insights from transcriptomic profiling
Date & time: December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Elyse R. Lopez, MD Anderson Cancer Center

BostonGene’s multimodal model, which integrates genomic, transcriptomic, and immunologic data, was used to analyze 444 invasive, inflammatory and metaplastic breast cancer samples. The analysis revealed distinct clinically relevant immune landscapes in both cancers, illustrating BostonGene’s ability to deliver reliable insights for treatment decision-making and optimal trial design.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS2-09-24
Title: Aurora kinase A (AURKA) A new druggable target in ER+ inflammatory breast cancer
Date & time: Wednesday, December 10, 2025; 5:00 PM – 6:30 PM
Presenter: Tanu Sharma, PhD, MD Anderson Cancer Center

Researchers at MD Anderson applied BostonGene’s comprehensive pipeline to analyze RNA and DNA samples from ER+ inflammatory breast cancer (IBC) tumors, revealing amplified expression of AURKA in IBC tumors and the potential for synthetic lethality, where therapeutic targeting of AURKA alongside another target could lead to cell death. These findings demonstrate BostonGene’s capability in integrating genomic and transcriptomic data with clinical outcomes to generate biologically grounded, actionable insights.

Research done in collaboration with MD Anderson Cancer Center

Presentation number: PS4-01-10
Title: Characterizing CCR7 gene amplification and protein expression in inflammatory and non-inflammatory breast cancer
Date & time: Thursday, December 11, 2025: 5:00 PM – 6:30 PM
Presenter: Surbhi Shivhare, PhD, MD Anderson Cancer Center

BostonGene, in collaboration with MD Anderson, applied its multimodal model to examine both CCR7 copy number alterations and gene expression in inflammatory breast cancer. This comprehensive study uncovered discordance across CCR7 copy numbers and RNA levels and pointed to the potential impact of membranous CCR7 protein toward disease status. Highlighting BostonGene’s target discovery applications, this study identified CCR7 as a promising therapeutic target for aggressive breast cancer.

Research done in collaboration with MD Anderson Cancer Center

(Press release, BostonGene, DEC 8, 2025, View Source [SID1234661295])

On December 8, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported it will present new data demonstrating how comprehensive genomic profiling (CGP) can refine diagnosis and guide treatment decisions for patients with myeloid malignancies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held Dec. 6–9, 2025, in Orlando, Florida.

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The poster, "Comprehensive genomic profiling refines diagnosis and reveals actionable fusions in myeloid malignancies: A real-world analysis," evaluated outcomes using the Neo Comprehensive Myeloid panel, a next-generation sequencing (NGS) assay that provides a complete view of genomic changes in myeloid cancers. By assessing mutations and fusions in a single test, this CGP panel detects important genomic variants that may otherwise be missed, and supports diagnosis, prognosis, and therapy selection for diseases such as acute myeloid leukemia (AML), myelodysplastic neoplasms (MDS), and myeloproliferative neoplasms (MPN).

Researchers analyzed data from 533 patients with myeloid disorders, integrating NeoGenomics’ molecular results with clinical data from national health information exchanges. The analysis found that in about one-third of patients tested, CGP identified pathogenic changes earlier in their disease, leading to diagnostic reclassification in several cases. It also revealed rare but clinically significant fusions—including PDGFRA, PDGFRB, FGFR1, and JAK2—that helped guide targeted treatment decisions.

"This study underscores our leadership in hematologic malignancy diagnostics and our long-standing commitment to improving cancer care in the community setting," said Warren Stone, President and Chief Operating Officer at NeoGenomics. "Patients living with complex blood cancers rely on timely and definitive answers, and their physicians deserve access to best-in-class molecular tools, regardless of practice location. Our next-generation myeloid CGP solution combines DNA and RNA sequencing in a single, comprehensive assay, providing actionable insights that smaller or DNA-only panels may miss. By expanding access to advanced diagnostics, we are enabling more personalized treatment decisions and working to improve the path to care for every patient, everywhere."

The study will be presented in session 908A, Outcomes Research: Myeloid Malignancies: Poster III, on December 8 from 6:00 to 8:00 p.m. ET. Conference attendees can also visit Booth #1971 in the ASH (Free ASH Whitepaper) 2025 Exhibit Hall to learn more about NeoGenomics’ hematology testing portfolio and ongoing research.

(Press release, NeoGenomics Laboratories, DEC 8, 2025, View Source [SID1234661294])

On December 8, 2025 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported promising preclinical data from the company’s novel, multi-functional protein degrader program and positive updated data from an ongoing Phase 1 combination study with OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor, as an add-on to ruxolitinib in patients with advanced myelofibrosis.

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Data were shared in an oral and poster presentation this past weekend at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 6-9, 2025, in Orlando, FL.

Multi-Functional Degraders Designed to Block Key Oncogenic Pathways Using Single Chemical Entity

Opna’s novel protein degraders are designed to block multiple oncogenic targets – EP300, CBP, IKZF1 and IKZF3 – concurrently in the same cancer cell, achieving potent single agent anti-tumor activity. EP300, CBP, IKZF1 and IKZF3 are known to promote the progression of multiple myeloma, a type of blood cancer derived from malignant plasma cells in the bone marrow. In a proof-of-concept OPM-2 multiple myeloma model, OPN-5667 potently reduced the levels of key oncoproteins in vitro and caused tumor regression in all treated animals in vivo. Opna’s medicinal chemistry campaign has produced compounds with improved potency and pharmacological properties, advancing the program towards clinical candidate selection.

The degrader program is built on foundational studies presented at ASH (Free ASH Whitepaper) in 2024 with OPN-6602, an oral EP300/CBP inhibitor, in combination with immunomodulatory drugs (IMiDs). The combination resulted in strong synergy in vivo including complete regressions and improved response durability. A Phase 1 study of OPN-6602 is currently enrolling patients with relapsed or refractory multiple myeloma at multiple sites in the U.S.

"These promising data support our goal of developing a single agent ‘super drug’ for hematological malignancies, such as multiple myeloma and lymphoma," said Gideon Bollag, PhD, chief scientific officer of Opna Bio. "We anticipate identifying a lead candidate in mid-2026 and submitting an IND in 2027."

OPN-2853 Reduces Spleen Size in Patients with Advanced Myelofibrosis

OPN-2853, a potent, orally active small molecule BET inhibitor, is being evaluated as an add-on to ruxolitinib in the PROMise study in patients with myelofibrosis who are no longer responding to ruxolitinib. Myelofibrosis is a type of blood cancer that causes bone marrow fibrosis, anemia and an enlarged spleen, amongst other symptoms.

As of October 2025, 29 patients had been enrolled across multiple sites in the United Kingdom. Fourteen patients were treated with 40 mg of OPN-2853 and 15 patients were treated with 80 mg of OPN-2853 added to ruxolitinib. In 16 of 26 evaluable patients, there was a 50% or greater reduction of their palpable spleen length on treatment when compared to baseline.

The combination dose has been well tolerated, and the majority of patients have completed eight cycles of combination treatment.

The investigator-initiated study is led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK) and is run through the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

"The emerging data from the PROMise study continue to be encouraging. We are now seeing consistent and clinically meaningful spleen size reductions, improvements in symptom burden, and durable benefit for patients who previously had limited options after an inadequate response to ruxolitinib alone," said Dr. Mead. "These findings strengthen our view that selective BET inhibition alongside JAK inhibition may offer a new therapeutic approach for patients with myelofibrosis."

(Press release, Opna Bio, DEC 8, 2025, View Source [SID1234661293])

On December 8, 2025 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology company focused on advancing precision oncology through biomarker innovation, reported the presentation of seven studies at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025, held December 9–12 in San Antonio, Texas.

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These abstracts showcase the growing clinical utility and innovation of the company’s proprietary RNA platform and underscore REVEAL GENOMICS’ commitment to improving outcomes for individuals with breast cancer.

Across all studies, REVEAL GENOMICS and its collaborators analyzed more than 1,300 tumor samples from individuals with HER2-positive, ER-negative, and triple-negative breast cancer—one of the most extensive genomic contributions to SABCS 2025.

Seven independent studies validate the performance and clinical impact of REVEAL GENOMICS’ precision oncology platform

New HER2DX Genomic Scores: Predicting Overall Survival and Brain Progression in Advanced HER2+ Breast Cancer
REVEAL GENOMICS presents two new analyses in a cohort of 215 individuals with advanced HER2-positive breast cancer, including 93 cases from Spain and 122 from Poland. The studies show that the HER2DX ERBB2 score, together with two newly developed genomic scores, independently predicts overall survival and the risk of brain progression in individuals treated with first-line therapy and in subsequent treatment settings.

These findings are particularly relevant in a landscape where multiple therapeutic options now exist, each with different levels of efficacy and tolerability. CNS progression remains a major unmet need, and until now no biomarker has been available to identify those at highest risk.

The newly developed HER2DX CNS Progression Score demonstrated a strong ability to stratify risk. In the Polish validation cohort, the 3-year cumulative incidence of CNS progression was 39.2% in the high-risk group, 13% in the intermediate-risk group, and 4.3% in the low-risk group.

Taken together, these results highlight the potential of HER2DX genomic scores—including the new CNS Progression Score—to guide treatment selection, personalize CNS surveillance, and ultimately improve outcomes for individuals with advanced HER2-positive breast cancer.

Operational Feasibility of HER2DX in the DEFINITIVE Trial
The DEFINITIVE trial (NCT06446882) is an ongoing, international, multicenter, randomized prospective clinical trial across Europe and Israel. Funded by the European Union, it has been designed to evaluate the impact of HER2DX-guided treatment in stage II-III HER2-positive breast cancer. The poster presented at SABCS 2025 shows real-time operational insights from the first 122 patients screened. HER2DX testing was successfully completed in 115 cases (success rate 94.3%). The median turnaround time from sample reception to result was 7 working days, confirming the feasibility of rapid, centralized genomic testing. These results support the integration of genomic classifiers into real-time treatment decision-making in prospective clinical trials.

HER2DX Genomic Test: SABCS 2025 & Newly Published Data
REVEAL GENOMICS also presents new data showing that HER2DX scores reflect pathological features from both the tumor and its immune microenvironment. However, no clinical-pathological variable could fully capture the information contained in the HER2DX scores. Most importantly, the HER2DX pCR score emerged as the only variable independently associated with pathologic complete response (pCR), even after adjusting for tumor-infiltrating lymphocytes (TILs). Notably, TILs were no longer predictive once the HER2DX pCR score was included in the analysis. These findings were recently published in Clinical Cancer Research.

HER2DX pCR Score vs. TILs in the COMPASSHER2 pCR Trial
A proffered paper (GS1-04) evaluated TILs in the COMPASSHER2 pCR trial from ECOG-ACRIN, comparing their performance with the HER2DX pCR score in 569 patients. HER2DX was assessed as a secondary aim within a pre-specified, prospectively planned analysis embedded in COMPASSHER2 pCR (EA1181; NCT04266249), a large multicenter phase II trial evaluating neoadjuvant THP in more than 2,000 patients with stage II–III HER2-positive breast cancer. The results are fully consistent with the previous work developed: although TILs are associated with pCR, their predictive value disappears once the HER2DX pCR score is included in the model. This further reinforces the superior predictive ability of the HER2DX pCR score compared with TILs alone for identifying patients most likely to achieve a pCR.

Prospective Evaluation of ERBB2 mRNA Score in ER-Negative Breast Cancer
A prospective pilot study evaluated whether the ERBB2 mRNA score—integrated into the HER2DX and TNBCDX assays—could streamline HER2 assessment in ER-negative breast cancer. Both assays were run blinded to HER2 status using their standard RNA-based platform. Based on the ERBB2 mRNA level, samples were automatically routed to the appropriate assay: ERBB2-low tumors generated a TNBCDX output, whereas ERBB2-medium/high tumors generated a HER2DX output. In parallel, all tumors underwent routine HER2 testing by IHC/ISH.

The ERBB2 mRNA score demonstrated perfect concordance with standard HER2 classification, correctly identifying every HER2-positive and HER2-negative case. These findings support RNA-based HER2 assessment as an accurate, rapid, and operationally simple approach that can help accelerate neoadjuvant decision-making in ER-negative disease.

Independent Validation of TNBCDX in Early Triple-Negative Breast Cancer
A new independent validation study in 164 patients from two Spanish academic centers confirms that the TNBCDX 15-gene assay—used to generate both the pCR score and the risk score—accurately predicts pCR and recurrence risk in early-stage TNBC, irrespective of anthracycline or pembrolizumab use. These results build on the Annals of Oncology publication, where TNBCDX was originally developed and validated in 527 patients across three prospective neoadjuvant studies. In that analysis, the TNBCDX pCR score was significantly associated with pCR, and the TNBCDX risk score consistently predicted long-term outcomes including distant disease-free survival, and overall survival.

Together, the original 527-patient dataset and this new independent 164-patient cohort provide converging evidence that TNBCDX is a robust and reproducible tool for refining risk stratification and supporting more individualized systemic therapy decisions in early-stage TNBC.

Company Leadership Highlights the Impact and Vision Behind These Breakthroughs
The leadership of REVEAL GENOMICS highlights the importance of the SABCS 2025 findings, emphasizing their impact on advancing precision oncology and supporting clinicians and patients.

Prof. Aleix Prat, MD, PhD, Co-founder and CSO, remarks: "These results reflect years of collaborative research and our commitment to translating genomic science into real-world benefits for patients. We are proud to see our tools making a tangible difference in breast cancer care. The breadth of data presented at SABCS 2025 demonstrates the versatility and clinical impact of our genomic platforms. We are excited to continue advancing precision oncology through robust science and innovation."

Dr Patricia Villagrasa, Co-founder and CEO, adds: "Our mission is to empower clinicians and patients with the best possible information for treatment decisions. The progress showcased at SABCS 2025 is a clear reflection of our team’s dedication and the trust placed in us by the oncology community."

(Press release, REVEAL GENOMICS, DEC 8, 2025, View Source [SID1234661292])