HER-2 expression

It received its first approval under accelerated approval in August 2025 in the USA following positive results from the Beamion LUNG-1 phase Ia/Ib trial in patients with previously treated HER2-mutant non-small cell lung cancer (NSCLC). This article summarizes the milestones in the development of zongertinib leading to this first approval for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

Addition of DV to BCG provided favorable early response and superior intermediate-term RFS for BCG-naïve HER2-expressing HR-NMIBC, highlighting its prospect in HR-NMIBC management.

Moreover, BB-1701, a novel HER2-ADC containing eribulin as a payload, to which N87 AR cells are sensitive, exhibited antitumor effects in N87 AR cells in vitro and in vivo. These findings indicate that ABC transporter-mediated drug efflux is an important mechanism underlying T-DXd resistance in HER2-positive gastric and lung cancer models. Furthermore, our study suggests that both targeting drug efflux pathways and utilizing alternative payloads may be effective strategies for overcoming T-DXd resistance in HER2-positive gastric and lung cancers.

P=N/A, N=105, Recruiting, AstraZeneca | N=384 --> 105

Our findings candidate R-115 as a promising alternative to standard glioblastoma treatments and support further investigation to advance its clinical application.

These research findings established silymarin as a potential alternative drug targeting PLK1, which is highly expressed in HER2-positive breast cancer, and modulates the oncogenic processes not just in breast cancer, but also in other cancers.

Integrating the clinical experience of Chinese pathologists and oncologists, and following expert panel discussions, a consensus on the clinical diagnosis and treatment of HER-2-low and HER-2-ultralow breast cancer was developed. This consensus aims to deepen clinicians' understanding of HER-2-low and HER-2-ultralow breast cancer, promote more precise clinical decision-making, and ultimately improve patient survival and quality of life.

P1, N=48, Recruiting, Orano Med LLC | Trial completion date: Aug 2027 --> May 2032 | Trial primary completion date: Aug 2026 --> Jan 2027

Her positive response, which surpassed the median progression-free survival rates seen in clinical trials, highlights the potential of precision medicine, where treatment is customized based on genetic and molecular tumor profiles. These new therapeutic options for difficult-to-treat cancer subtypes expand treatment possibilities, ushering in a new era of personalized and precision-driven oncology.

Among them, ATF-2 demonstrated antiproliferative activity comparable to HER2 inhibitor lapatinib and significantly suppressed HER2 expression and activity, epidermal growth factor receptor (EGFR) activity, and cyclin-dependent kinase 6 (CDK6) expression in HCC1954 breast cancer cells. These findings highlight ATF-2 as a promising dual HSP90-HER2 inhibitor with broader inhibitory effects on the HER2, EGFR, and CDK6 pathways.

EOGC represents a biologically distinct subset of gastric cancer with unique genomic and immunological features. These findings support age-specific diagnostic approaches and emphasize the value of multiomic strategies to uncover the mechanisms driving early-onset disease.