Enhertu (fam-trastuzumab deruxtecan-nxki)

In patients with BCBM, T-DXd-associated ILD/pneumonitis occurred in 10% of patient and frequently necessitated treatment modification. Although no fatal ILD was observed, the high discontinuation rate underscored the imperative for vigilant monitoring and protocol-guided management to mitigate pulmonary toxicity while preserving intracranial efficacy.

P1, N=48, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

Approximately 40 % of young women with luminal HER2-negative breast cancers have HER2-low or ultralow disease. These findings highlight the importance of accurately assessing HER2 expression in YWBC to identify candidates for emerging HER2-targeted therapies such as trastuzumab deruxtecan.

P=N/A, N=50, Not yet recruiting, Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

P=N/A, N=46, Not yet recruiting, The Affiliated Hospital of Inner Mongolia Medical University; The Affiliated Hospital of Inner Mongolia Medical University

P4, N=120, Not yet recruiting, Tianjin Cancer Hospital Airport Hospita; Tianjin Cancer Hospital Airport Hospita

P4, N=200, Not yet recruiting, The First Affiliated Hospital of Jinzhou Medical University; The First Affiliated Hospital of Jinzhou Medical University

The broad aims of this paper are: (a) To draw attention to some of the challenges associated with identifying whether patients have HER2-low metastatic breast cancer (mBC), in an environment where healthcare professionals have previously only needed to determine whether mBC is HER2-positive and therefore likely to respond to traditional HER2-targeted therapies; and (b) to indicate, where possible, what might be done to help overcome specific challenges in this regard. Advice regarding the management of specific T-DXd-related side effects of interest, including interstitial lung disease and pneumonitis, left ventricular dysfunction and emesis, is also offered.

T-DXd efficacy appears consistent across different age groups, although elderly patients showed reduced OS. Higher BMI was associated with improved PFS but increased toxicity. While DDIs did not affect survival outcomes, they influenced specific adverse events. Our results reinforce the efficacy and favorable safety profile of T-DXd in a broad real-world population, including patients with polypharmacy or comorbidities, while highlighting that personalized monitoring and supportive care strategies may be particularly beneficial for elderly patients and those with higher BMI.

HER2 staining was lower in 4B5 testing than in the HercepTest. Companion diagnosis using 4B5 is required to determine indications for T-DXd, especially for HER2-ultralow evaluations.

Trastuzumab first established HER2-targeted therapy in gastric cancer, but the failure of trastuzumab emtansine (T-DM1) led to a decade-long stagnation until the advent of trastuzumab deruxtecan (T-DXd), which demonstrated robust clinical activity and defined a new standard of care. While bevacizumab failed to improve survival, the anti-VEGFR2 antibody ramucirumab emerged as an effective second-line therapy. Immune checkpoint inhibitors, including nivolumab and pembrolizumab, have been incorporated into first-line treatment for PD-L1-positive disease based on landmark trials such as CheckMate 649 and KEYNOTE-811. More recently, the CLDN18.2-targeted antibody zolbetuximab has expanded therapeutic options for biomarker-selected patients. Concurrently, a diverse pipeline of immune-based strategies-such as TROP2-directed ADCs, bispecific antibodies, and CAR-T cell therapies-is undergoing active clinical development. Together, advances in biomarker-driven antibody therapeutics are accelerating personalized cancer care and improving clinical outcomes in patients with gastric cancer.

Breast cancer (BC) patients with low expression of human epidermal growth factor receptor 2 (HER2), now classified as HER2-low, may benefit from new novel antibody-drug conjugates, such as trastuzumab deruxtecan...The combined model C, composed of mpMRI model C (DCEphase7+DWI+T2WI) and clinical-imaging model, showed the best predictive performance, with AUCs of 0.952 and 0.892 in the training and testing sets. The mpMRI-based radiomics models had potential to noninvasively predict the HER2 status in IHC 2+ BC patients.