In September 2025, imlunestrant was approved for the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy in the USA. This article summarizes the milestones in the development of imlunestrant leading to this first approval for use in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

2 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)

ER positive • HER-2 negative • HER-2 mutation • ESR1 mutation

Inluriyo (imlunestrant)

Unsupervised Random Forest Identifies Important Genetic Prognostic Factors for Breast Cancer Survival Time. (PubMed, Cancer Inform)

Based on gene ontology analysis, we additionally show that these genes have plausible connections to breast cancer biology that should be experimentally investigated. Here, we demonstrate the utility of the unsupervised random forest model over K-means clustering for identifying important genes in breast cancer.

4 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation

Genomic Correlations for Clinical Outcomes in HER2-positive Advanced Gastric Cancer Treated Using Trastuzumab-based Therapy. (PubMed, Anticancer Res)

ERBB2 focal amplification is associated with improved outcomes in trastuzumab-treated patients with HER2-positive gastric cancer, whereas NOTCH3 alterations predict a poor prognosis. These genomic features may support risk stratification and therapeutic decisions.

6 days ago

Clinical data • Retrospective data • Journal

HER-2 (Human epidermal growth factor receptor 2) • NOTCH3 (Notch Receptor 3)

HER-2 positive • HER-2 amplification • HER-2 mutation

Herceptin (trastuzumab)

Towards biomarker-driven therapies for urothelial carcinoma. (PubMed, Nat Rev Clin Oncol)

In the past few years, circulating tumour DNA has emerged as a minimally invasive biomarker, with increasing data supporting its prognostic value and utility for monitoring clinical responses. In this Review, we address these developments and discuss biomarkers that could have clinical utility in patients with aUC.

8 days ago

Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • TMB (Tumor Mutational Burden) • FGFR3 (Fibroblast growth factor receptor 3)

PD-L1 expression • HER-2 overexpression • HER-2 mutation • FGFR3 mutation

Descriptive Genomic Analysis of Ampullary Carcinoma Utilizing the AACR Project GENIE Dataset. (PubMed, Curr Issues Mol Biol)

Reduced survival rates were seen in populations with the TP53 or KRAS mutation. This study provides a detailed descriptive genomic landscape of ampullary carcinoma, highlighting frequent mutations between patient groups and the mutational burden of the DNA damage response pathway in ampullary cancer, laying important groundwork for the development of therapeutic targets and more individualized treatment regimens.

9 days ago

Journal • Tumor mutational burden

HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • KMT2D (Lysine Methyltransferase 2D) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • APC (APC Regulator Of WNT Signaling Pathway)

TP53 mutation • KRAS mutation • PIK3CA mutation • HER-2 mutation • ARID1A mutation

10d

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)

P2, N=88, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting

10 days ago

Enrollment closed

HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)

HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive

trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • AiRuiEn (rezvilutamide) • tizetatug rezetecan (SHR-A1921)

13d

Review of risk factors and surgical treatment progress for gallbladder cancer. (PubMed, Hereditas)

Combating GBC requires a comprehensive strategy encompassing health education, screening of high-risk populations, precise staging, and individualized multimodal treatment. Future research should focus on building molecular subtype-based prognostic models, conducting high-level clinical studies to resolve surgical controversies, and exploring the integration of novel adjuvant therapies with traditional surgery.

13 days ago

Review • Journal • PD(L)-1 Biomarker • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NTRK (Neurotrophic receptor tyrosine kinase)

TP53 mutation • HER-2 mutation

18d

Distinct molecular signatures of upper tract urothelial carcinoma in Southwestern Taiwan: implications for targeted therapy and disease progression. (PubMed, Am J Cancer Res)

Our findings reveal a distinct molecular signature of UTUC in Southwestern Taiwan, with early- and late-stage tumors showing divergent mutational landscapes. These insights emphasize the importance of molecular stratification in UTUC management and suggest that a broader repertoire of targeted therapies could benefit patients in this high-incidence region.

18 days ago

Journal • Tumor mutational burden • BRCA Biomarker

HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3)

TP53 mutation • TMB-H • PIK3CA mutation • HER-2 mutation • FGFR3 mutation

TruSight Oncology 500 Assay

22d

Case Report: From teratoma to adenocarcinoma: molecular insights into somatic-type malignancy in testicular germ cell tumors - two case reports and review of the literature. (PubMed, Pathol Oncol Res)

Both cases were managed with capecitabine-oxaliplatin plus bevacizumab, followed by maintenance therapy, achieving disease stabilization for at least 9 months. Given the rarity of STM, especially in metastatic or recurrent settings, there is an urgent need for standardized diagnostic protocols and evidence-based treatment strategies. These cases support the use of tumor-specific chemotherapy regimens guided by the histological and molecular characteristics of STM.

22 days ago

Journal

TP53 mutation • KRAS mutation • HER-2 amplification • PIK3CA mutation • HER-2 mutation • STK11 mutation • KRAS amplification

Avastin (bevacizumab) • capecitabine • oxaliplatin

23d

SOHO-01: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)

P1/2, N=370, Active, not recruiting, Bayer | Trial primary completion date: Dec 2025 --> Nov 2026

23 days ago

Trial primary completion date • First-in-human

HER-2 (Human epidermal growth factor receptor 2)

EGFR mutation • HER-2 mutation

Hyrnuo (sevabertinib)

25d

Trastuzumab Deruxtecan in HER2-Low or HER2-Mutant Recurrent/Metastatic Secretory Gland Cancers of the Head and Neck: A Case Series. (PubMed, J Natl Compr Canc Netw)

T-DXd demonstrated promising and durable antitumor activity. This antibody-drug conjugate should be considered a viable therapeutic option for HER2-low and HER2-mutant R/M SGC/LGC, with potential use in the frontline setting when preferred systemic therapies are unavailable.

25 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2)

HER-2 positive • HER-2 mutation

Enhertu (fam-trastuzumab deruxtecan-nxki)