the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC

The study consists of a screening period of 28 days, a treatment period. Local or central testing of PIK3CA mutation in blood or tumor tissue must be performed using an approved polymerase chain reaction (PCR)-based or next generation sequencing (NGS) assay at a clinical laboratory. Patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive:
Neoadjuvant treatment with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w and nab-paclitaxel (125 mg/m2 on days 1, 8, and 15) in 3-week cycle for total 6 cycles
* with inavolisib (6 cycles) or
* without inavolisib. In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient.
All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate.

Start Date15 Dec 2025

Sponsor / Collaborator

Fudan University

NCT07246317

/ Not yet recruitingPhase 2IIT

A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer

This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.

Start Date15 Dec 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07193394

/ Not yet recruitingPhase 2IIT

Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer: a Proof of Concept Study (H3RAKLES)

The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine.
The H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.

Start Date05 Dec 2025

Sponsor / Collaborator

Institut Curie

[+3]

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

13,398

Literatures (Medical) associated with Trastuzumab

31 Dec 2025·mAbs

Tuning antibody stability and function by rational designs of framework mutations

Article

Author: Ng, Joseph C F ; Patel, Semil ; Cheung, Anthony ; Fraternali, Franca ; Karagiannis, Sophia N ; McCraw, Alexandra ; Chu, Tooki ; Grandits, Melanie ; Chauhan, Jitesh ; Iancu, Daniela ; De Sciscio, Maria Laura ; Kosmider, Alice ; Liu, Yi ; Guo, Dongjun ; Chenoweth, Alicia

Artificial intelligence and machine learning models have been developed to engineer antibodies for specific recognition of antigens. These approaches, however, often focus on the antibody complementarity-determining region (CDR) whilst ignoring the immunoglobulin framework (FW), which provides structural rigidity and support for the flexible CDR loops. Here we present an integrated computational-experimental workflow, combining static structure analyses, molecular dynamics simulations and in vitro physicochemical and functional assays to generate rational designs of FW mutations for modulating antibody stability and activity. We first showed that recent antibody-specific language models lacked insights in FW mutagenesis, in comparison to approaches that use antibody structure information. Using the widely used breast cancer therapeutic trastuzumab as a use case, we designed stabilizing mutants which were distal to the CDR and preserved the antibody's functionality to engage its cognate antigen (HER2) and induce antibody-dependent cellular cytotoxicity. Interestingly, guided by local backbone motions predicted using molecular dynamics simulations, we designed a FW mutation on the trastuzumab light chain that retained antigen-binding effects, but lost Fab-mediated and Fc-mediated effector functions. This highlighted the effects of FW on immunological functions engendered in distal areas of the antibody, and the importance of considering attributes other than binding affinity when assessing antibody function. Our approach incorporates interdomain dynamics and distal effects between FW and the Fc domains, expands the scope of antibody engineering beyond the CDR, and underscores the importance of a holistic perspective that considers the entire antibody structure in optimizing antibody stability, developability and function.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Discussion on the mechanism of HER2 resistance in esophagogastric junction and gastric cancer in the era of immunotherapy

Review

Author: Li, Weiling ; Zhao, Jun ; Fan, Wenxuan ; Gao, Yangjun ; Zhang, Yan ; Hu, Wenqing ; Su, Fei ; Zhang, Xiaoling ; Du, Yunyi

Human epidermal growth factor receptor 2 (HER2) is a critical biomarker and therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancers, despite the initial success of HER2-targeted therapies, such as trastuzumab, resistance to these drugs has emerged as a major impediment to effective long-term treatment. This review examines the mechanisms of drug resistance in HER2-positive G/GEJ cancer, the primary mechanisms of resistance explored include alterations in the HER2 receptor itself, such as mutations and changes in expression levels, as well as downstream signaling pathways, and interactions with the tumor microenvironment (TME). Furthermore, the review discusses the Novel therapeutic approaches, including the use of antibody-drug conjugates (ADCs) and combination therapies are assessed for their potential to enhance outcomes. By integrating recent research findings and clinical trials, this review aims to provide oncologists and researchers with insights into developing more effective treatments for patients with drug-resistant HER2-positive G/GEJ cancer.

31 Dec 2025·ANNALS OF MEDICINE

Next-generation sequencing in breast cancer: current clinical applications and future directions

Review

Author: Siddig, Alaa ; Wan Abdul Rahman, Wan Faiziah ; Tengku Din, Tengku Ahmad Damitri Al-Astani ; Yahya, Maya Mazuwin ; Wan Zain, Wan Zainira ; Mohd Zuhdi, Nur Fatihah ; Mohd Nafi, Siti Norasikin ; Md Salleh, Md Salzihan

INTRODUCTION:

Breast cancer is a heterogeneous disease that claims 670,000 lives by 2022. Omic technologies, particularly next generation sequencing (NGS) offers promising avenues for precision medicine. American Society of Clinical Oncology (ASCO) outlines genomic testing's utility, emphasizing prognostic and diagnostic potential.

OBJECTIVES:

This review succinctly explores NGS's evolution and clinical applications of NGS in breast cancer, thereby guiding future research to enhance patient care.

METHODS:

Comprehensive literature searches were conducted using databases such as PubMed, Google Scholar, and ResearchGate, focusing on keywords including breast cancer, HER-2 low breast cancer, circulating tumour DNA, single-cell RNA sequencing, and next-generation sequencing. Peer-reviewed, high-quality articles published in English were selected for inclusion.

RESULTS:

Previous studies have explored the evolution of NGS technology and its clinical applications in breast cancer, including genomic and transcriptomic characterization, treatment guidance, and resistance prediction. Molecular profiling of challenging entities such as early-onset breast cancer and HER-2 low tumours was summarized, with key findings highlighted. This review also discusses emerging technologies, including circulating DNA and single-cell sequencing, as promising avenues for discovery.

CONCLUSION:

NGS has revealed the genomic and transcriptomic diversity of breast cancer, identifying actionable alterations associated with chemotherapy response and resistance to therapies such as trastuzumab, TKIs, and CDK4/6 inhibitors. Circulating tumour DNA (ctDNA) shows potential for diagnosis, prediction, prognosis, and monitoring, despite tumour heterogeneity. Single-cell analysis enables exploration of individual cell transcriptomes, though high costs and low throughput remain barriers to widespread adoption. HER2-low tumours continue to pose significant research challenges.

879

News (Medical) associated with Trastuzumab

02 Dec 2025

·www.businesswire.com

New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., today announced that 11 studies featuring the Breast Cancer Index® (BCI™) Test will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions. New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration “These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types.” Among the new findings to be presented, one study, “Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27],” explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^* “As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life,” said primary study author Dr. Ruth O’Regan, MD. “The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects.” A full list of studies to be presented at the 2025 SABCS conference includes: Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including: Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 “The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test,” said Schneiders. “With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients.” About the Breast Cancer Index Test The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO® Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7 The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com. About Hologic, Inc. Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s and its subsidiaries’ products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. ^Note: Incorporation of refined risk estimates in the results reported by the Breast Cancer Index test are pending appropriate regulatory approvals. For the Breast Cancer Index Intended Uses and Limitations, please visit breastcancerindex.com. *Biotheranostics, Inc. researchers are named authors in this study. Hologic, Breast Cancer Index, BCI and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners. References Zhang Y, et al. Breast Cancer Index identifies early-stage estrogen receptor–positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013;19(15):4196-4205. doi:10.1158/1078-0432.CCR-13-0804. Sgroi DC, et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. JNCI J Natl Cancer Inst . 2013;105(14):1036-1042. doi:10.1093/jnci/djt146. Bartlett JMS, et al. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen–To Offer More? (aTTom) trial. Ann Oncol. 2019;30(11):1776-1783. doi:10.1093/annonc/mdz289. Noordhoek I, et al. Breast Cancer Index predicts extended endocrine benefit to individualize selection of patients with HR‐positive early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res. 2021;27(1):311-319. doi:10.1158/1078-0432.CCR-20-2737. Mamounas EP, et al. Breast Cancer Index (BCI) and prediction of benefit from extended aromatase inhibitor therapy in HR+ breast cancer: NRG Oncology/NSABP B-42. J Clin Oncol . 2021;39(15_suppl):501. doi:10.1200/JCO.2021.39.15_suppl.501 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Breast Cancer V.5.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed November 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO): Clinical Practice Guideline Endorsements for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology, 2025. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs-org.libproxy1.nus.edu.sg/guidelines [ascopubs.org]. ASCO Clinical Practice Guideline makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way. O’Regan R, et al. Identifying premenopausal patients with early-stage hormone receptor–positive node-negative breast cancer at minimal risk of distant recurrence by Breast Cancer Index. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Yadav S, et al. Endocrine sensitivity and predicted benefit of extended endocrine therapy based on Breast Cancer Index (BCI) in BRCA1, BRCA2, and CHEK2 pathogenic variant carriers with ER+/HER2– breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10, 2025; San Antonio, TX. Chuy V, et al. Breast Cancer Index re-stratifies 21-gene assay risk groups for risk of recurrence and extended endocrine therapy benefit: Final analysis of the BCI Registry Study. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Chumsri S, et al. Prognostic performance of Breast Cancer Index in patients with early-stage HR+ HER2+ breast cancer treated with adjuvant trastuzumab: NCCTG N9831 (Alliance). Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Sandoval-Leon AC, et al. Comparative analysis of Breast Cancer Index testing in Hispanic and non-Hispanic populations. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Kapoor NS, et al. Comparison of Breast Cancer Index scores from core-needle biopsies versus surgical excisions in early-stage breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Tran CC, et al. Guidelines for Breast Cancer Index test before and after Epic software enhancement. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Ogunsesan Y, et al. Higher breast tumor grades could more likely benefit from extended adjuvant endocrine therapy . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Rupani KV, et al. Correlation between Breast Cancer Index (BCI) and RSClin late in assessing 5–10-year recurrence risk in early-stage hormone receptor–positive breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Essarani M, et al. Retrospective study on Breast Cancer Index testing in a community hospital and analysis of its impact on physician decision-making for extended endocrine therapy in early breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Flood B, et al. Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. SOURCE: Hologic, Inc.

ASCO

26 Nov 2025

·www.prnewswire.com

Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America

SINGAPORE, Nov. 26, 2025 /PRNewswire/ -- Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay. Tuznue® is a biosimilar to Herceptin® (trastuzumab), approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received European Commission (EC) marketing authorization for Tuznue® in September 2024. This approval marks a major milestone for the company's biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across key global markets. Under the agreement, Biosidus secures exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, leveraging its extensive commercial network and deep expertise in biosimilar adoption. Prestige Biopharma will be responsible for the production and supply of the drug substance through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia. Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to announce our strategic partnership with Biosidus for Argentina and other key markets in Latin America. With its proven track record and deep regional expertise, Biosidus represents an ideal partner for the successful manufacturing and commercialization of our lead biosimilar. We are confident that this collaboration will further enhance the global value and reach of our biosimilar portfolio." Mariano Elizalde, CEO of Biosidus, said: "We are proud to partner with Prestige Biopharma to introduce Tuznue® in selected markets across Latin America. This agreement strengthens our Biosimilars portfolio and our commitment to expand access to biotechnological medicines in Latin America. Together with Prestige Biopharma, we are confident in offering patients and healthcare professionals a quality and affordable therapeutic option". About Tuznue® Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class PAUF-based antibody drug, ulenistamab, has received Orphan Drug Designation from the U.S. FDA, the European EMA, and the Korean MFDS, along with Fast Track Designation from the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. About Biosidus Biosidus is an Argentine company, a pioneer in biotechnology, which over the last 42 years has achieved a leadership position in Latin America and a growing share in other emerging markets in Asia, Africa and Eastern Europe, developing, producing and marketing biopharmaceuticals of the highest quality at affordable prices. 21% more press release views with Request a Demo

Orphan DrugLicense out/inDrug ApprovalFast Track

25 Nov 2025

·www.businesswire.com

Vyome Appoints Renowned Medical Oncologist, Dr Aditya Bardia as Senior Medical Advisor to Guide the Development of MFW Program

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vyome Holdings, Inc. (“Vyome”) (NASDAQ: HIND), a clinical-stage healthcare holding company, today announced Dr. Aditya Bardia as Senior Medical Advisor to Vyome. In this consulting role, Dr. Bardia will guide the clinical development of Vyome’s lead asset, VT-1953, for the treatment of symptoms of malignant fungating wounds (MFW), a debilitating condition in cancer patients for which approval is being targeted in 2026. “I am excited to work with Vyome team and guide the clinical development of VT-1953 for the treatment of symptoms of malignant fungating wound, a debilitating condition that can significantly impair quality of life for patients with cancer,” said Dr. Bardia. “In my clinical practice, I have seen patients suffer from this horrible condition, and we really need an effective treatment for this major unmet clinical need. I am encouraged by the preliminary data with VT-1953 in MFW, and the mechanistic basis for this therapy. This is the perfect opportunity to develop a first-in-class therapy, which can improve the quality of life for patients with cancer.” Dr. Bardia has led clinical trials that have resulted in many drug approvals, including Sacituzumab Govitecan, Trastuzumab Deruxtecan, and Datopotamab Deruxtecan, which became blockbuster drugs. Dr. Bardia also led the clinical development of Elacestrant, the first oral SERD approved for patients with metastatic HR+ positive breast cancer. Trained at Johns Hopkins in medical oncology, Dr. Bardia joined Massachusetts General Hospital-Harvard Medical School as a faculty member before moving to David Geffen School of Medicine at UCLA and the UCLA Health Jonsson Comprehensive Cancer Center as Professor and director of the Breast Cancer Program and Translational Research Integration. He has also received numerous awards and honors. “Dr. Bardia’s expertise in having led the development of multiple drugs and especially steering them through accelerated FDA approvals aligns with our strategy of designing robust, but cost-efficient, trials,” said Dr. Shiladitya Sengupta, Associate Professor of Medicine, Harvard Medical School, and Co-Founder of Vyome. “We are delighted that Dr. Bardia decided to work with the Vyome team, significantly bolstering our depth in developing next-generation therapies, as we embark on pivotal studies with our lead asset.” “The collaboration with Dr. Bardia marks an important milestone in Vyome’s growth journey. We have a brilliant team in place to unlock the next milestones of value in our lead program,” said Venkat Nelabhotla, CEO of Vyome. About MFW MFW is a debilitating condition that occurs in 5-14% of advanced cancer patients, and it’s estimated that there are over 650,000 patients with advanced cancer in the US, with approximately 10 million patients globally. These numbers were recently confirmed in the latest research published in June 2025(1). Cancer cells break through the skin and cause a chronic wound (MFW), which is extremely distressing to patients, given the high burden of symptoms, including extreme malodor, severe pain, a feeling of shame, low self-esteem, and social isolation(2). VT-1953 topical gel is designed to treat the symptoms of MFW by targeting the cause of malodor and inhibiting the drivers of inflammation. In prior clinical studies, VT-1953 topical gel has been well tolerated in over 500 patients. In the interim analysis, VT-1953, which exerts an immuno-anti-inflammatory effect by targeting TLR-MD2 and DNA gyrase, significantly reduced malodor symptom (P<0.001), as scored by clinical investigators using a TELER Odor scale, the primary endpoint in this interim analysis. Patients also reported a significant reduction in lesion pain scored on a visual analog scale (VAS) (P<0.001) and an improvement in quality of life (P<0.001), both secondary and exploratory end points, respectively, in the study. No clinically significant adverse trends were noted with VT-1953 administration(3). References: (1) Daniela Nigrelli, Francesca Gambalunga, Giuliano Anastasi, Angela Peghetti, Stefano Durante, Martina Giusti, Valentina Biagioli, Silvio Quirini, Laura Iacorossi, Roberto Latina. Malignant fungating wounds assessment in palliative care: a scoping review https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1602493/full (2) Alexander, S.J. An intense and unforgettable experience: the lived experience of malignant wounds from the perspectives of patients, caregivers and nurses. International Journal of Woundcare. 2010, 7:456-465 https://aacrjournals-org.libproxy1.nus.edu.sg/cancerres/article/85/8_Supplement_2/CT091/761756/Abstract-CT091-Interim-results-from-a-phase-2 (3) Arshit Narang, Prashant Prakash Lad, Shiladitya Sengupta. Interim results from a phase 2 trial testing the safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wounds [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT091. About Vyome Holdings, Inc. Vyome is building the world’s premier platform spanning the US-India innovation corridor. Based in Cambridge, MA, Vyome’s immediate focus is on leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning across the US-India innovation corridor, Vyome seeks to deliver lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com Forward-Looking Statements Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “target,” “believe,” “expect,” “will,” “shall,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” “forecast,” “intend,” “plan,” “project,” “outlook”, and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements, include, but are not limited to, statements contained in this press release relating to Vyome’s business strategy, Vyome’s future operating results and liquidity and capital resources outlook. Forward-looking statements are based on Vyome’s current expectations and assumptions regarding Vyome’s business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Vyome’s actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Vyome cautions you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, Vyome’s ability to raise capital to fund continuing operations; our ability to protect Vyome’s intellectual property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and products; Vyome’s ability to develop and commercialize products and services; changes in government regulation; Vyome’s ability to complete capital raising transactions; and other factors relating to Vyome’s industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause Vyome’s actual results to differ may emerge from time to time, and it is not possible for Vyome to predict all of them. Vyome cannot guarantee future results, levels of activity, performance or achievements. Vyome assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.

Phase 2Clinical ResultExecutive ChangeDrug Approval

100 Deals associated with Trastuzumab

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KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Not Applicable	Advanced Malignant Solid Neoplasm	1,120	Small molecule targeted agents (SMs)	szuogojsbl(ikpntegult) = blfacrcmwz tplxgsnddy (msvchaboje, 0.52 - 3.71) View more	Positive	17 Oct 2025
				Immune checkpoint inhibitors (ICIs)	isagywzevg(tlsokqmknw) = rnbfpjvtdy eqnjtodgwh (aexacnetlr, 12 - 23)
ASPEN-09-03 (ESMO2025)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	80	Evorpacept + Trastuzumab + Chemotherapy	ktmdrgtbhv(vodrmggsmq) = tyrzmrpfxl hrxnalfjum (devbvrbgnl )	Positive	17 Oct 2025
ESMO2025	Not Applicable	HER2-positive	237	TKI plus anti-HER2 antibody	ttrurxkznd(iwkeyzpsnl) = bxufrbjkww rvfocqbqxn (ulrlulcbry ) View more	Negative	17 Oct 2025
				TKI	ttrurxkznd(iwkeyzpsnl) = fjcmnynxhc rvfocqbqxn (ulrlulcbry ) View more
NCT06031233 (ESMO2025)	Phase 1	-	45	Atezolizumab	eoulkmtjmq(byqdotabhr) = Only three IRRs grade 1 occurred, of which one during 30-minute infusion of durvalumab, and two IRRs grade 1 during accelerated trastuzumab infusions ajqcuaincb (eecnbyfvgw )	Positive	17 Oct 2025
NCT03820141 (ESMO2025)	Phase 2	Early Stage Breast Carcinoma Neoadjuvant ER-negative \| PR-negative \| HER2-Enriched (BluePrint)	37	durvalumab+trastuzumab+pertuzumab	hoblgwbxlx(svknrcddzh) = xzzelxakor ypbpcdjaqn (wjzenveaev )	Positive	17 Oct 2025
ESMO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	127	Docetaxel, trastuzumab, and pertuzumab (THP)	paehbcahks(jkvtbdvlps) = pbbxelhvzd mbhzoaoxfd (lpdiainggm ) View more	Positive	17 Oct 2025
				Docetaxel, trastuzumab, and pertuzumab (THP) (SUVmax >10)	paehbcahks(jkvtbdvlps) = kyqcvttyjb mbhzoaoxfd (lpdiainggm ) View more
NCT02091141 (MyPathway, ESMO2025)	Phase 2	HER2 Positive Colorectal Cancer HER2-positive	70	pertuzumab+trastuzumab (RAS wt pts with prior EGFRi)	zszuuancfr(gfuejtmpzf) = syeznblxik pnxagplqsr (pnwcdstffx ) View more	Negative	17 Oct 2025
				pertuzumab+trastuzumab (RAS wt pts without prior EGFRi)	zszuuancfr(gfuejtmpzf) = wsdzdzrztf pnxagplqsr (pnwcdstffx ) View more
ESMO2025	Not Applicable	Non-Small Cell Lung Cancer	12,820	Osimertinib	qzyoczkmcw(apyeqqoiqk) = trpdwmavju kxvepwfsnd (lozykkjnpx, 0.7 - 1.4) View more	Positive	17 Oct 2025
				Alectinib	qzyoczkmcw(apyeqqoiqk) = ajxyfbqjvh kxvepwfsnd (lozykkjnpx, 0.2 - 0.6) View more
NCT05132582 (HER2CLIMB-05, BusinessWire) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	-	TUKYSA + trastuzumab + pertuzumab	gukfczcacb(bsfbtctuaw) = biulnhfwdo qervuhknfe (mkrmmwfrga ) Met	Positive	14 Oct 2025
				Placebo + trastuzumab + pertuzumab	-
NCT04744831 \| NCT03418558 \| NCT03384940 (RHEA, ESMO_GI2025) Manual	Phase 2	HER2 Positive Colorectal Cancer HER2 Positive	26	TDM-1 or trastuzumab-deruxtecan or trastuzumab/lapatinib or trastuzumab/pertuzumab or pertuzumab/TDM-1	ubspkkrhuj(cdzvbqtnfb) = udwzdvdubd ifrjocrsis (ozuitfpqyg ) View more	Positive	03 Jul 2025

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