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trastuzumab (HS 022 / HS022 / anruize)

✓ Approved

BioRay Pharmaceutical · ERBB2 · 单克隆抗体

什么是 trastuzumab？

trastuzumab 是一种单克隆抗体，由BioRay Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名HS 022, HS022, anruize
公司BioRay Pharmaceutical
药物类别单克隆抗体, 抗体
分子靶点ERBB2
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, BioRay Pharmaceutical

作用机制

分子靶点

trastuzumab 作用于 1 个分子靶点：

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

trastuzumab 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancer✓ Approved

相关研究文献

PubMedJACC. CardioOncology2026-09-10

Real-World Cardiotoxicity of Biosimilar versus Reference Trastuzumab in Early HER2-Positive Breast Cancer.

Jackson Inimfon I, Zhang Ning N, Sullivan Marija M, Zhao Hui H et al.

Trastuzumab has greatly improved outcomes in patients with human epidermal growth factor receptor 2-positive breast cancer. To reduce costs and increase access, biosimilar products were approved after trials demonstrated short-term safety similar to that of reference trastuzumab. However, real-world data on cardiac safety are limited. We evaluated the adoption of biosimilar trastuzumab and compared heart failure (HF) risk between users of reference and biosimilar trastuzumab. Patients aged ≥18 years with breast cancer who received trastuzumab from 2018 to 2024 were identified in the IQVIA PharMetrics Plus Closed Health Plan Claims database. Patients who underwent surgery within the first year after cancer diagnosis were selected as a proxy for early-stage disease. Healthcare Common Procedure Coding System Level II codes were used to identify reference and biosimilar trastuzumab use, and International Classification of Diseases codes were used to identify HF diagnoses. Patients with an HF diagnosis before breast cancer surgery were excluded. Multivariable cause-specific Cox proportional hazards regression was used to examine the association of reference vs biosimilar trastuzumab use with HF risk. Among 5,135 patients identified, 43.9% received reference trastuzumab. Use of biosimilar trastuzumab increased from 0% in 2018 to 71.3% in 2024 (P < 0.001). The overall rate of HF was 5.9% (5.5% among reference trastuzumab users vs 6.3% among biosimilar trastuzumab users; P = 0.26). In multivariable analysis, there was no statistically significant difference in HF risk between patients treated with biosimilar trastuzumab and those treated with reference trastuzumab (adjusted HR [aHR]: 1.16; 95% CI: 0.92-1.46). Patients with a Charlson Comorbidity Index score ≥2 had a higher risk of HF than those with a score of 0 (aHR: 1.52; 95% CI: 1.11-2.08). Compared with patients aged 18 to 54 years, those aged 65 to 74 years (aHR: 1.61; 95% CI: 1.19-2.19) and ≥75 years (aHR: 1.95; 95% CI: 1.29-2.96) had a higher risk of HF. As biosimilar trastuzumab use continues to increase, our findings provide reassurance regarding its cardiac safety in the management of early-stage human epidermal growth factor receptor 2 breast cancer. Additional studies with longer follow-up are needed to confirm these findings and evaluate long-term cardiac outcomes.

PMID 42720642
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PubMedFrontiers in pharmacology2026-09-10

Trastuzumab-TKI combination in HER2-Positive tumors: a FAERS-Based safety profile and multimodal analysis of Tanespimycin's role in enhancing targeting of the HSP90AA1-PI3K-Akt-mTOR axis.

Chen Xiao X, Han Xiao X, Zhang Yuanyuan Y, Cao Junming J et al.

This study addresses the safety profiles and molecular mechanisms of trastuzumab monotherapy and its combination with lapatinib, neratinib, and tucatinib for treating HER2-positive tumors. The research integrates a multi-platform approach, including data from the US Food and Drug Administration Adverse Event Reporting System (FAERS), network pharmacology, molecular docking, molecular dynamics simulations, and in vitro experiments. Specifically, 38,300 FAERS reports were screened, alongside a series of in silico modeling and laboratory assays to systematically evaluate drug safety and therapeutic mechanisms. Pharmacovigilance analysis revealed that trastuzumab monotherapy was associated with an elevated incidence of cardiac and tumor progression-related adverse events (AEs). Combination therapies showed longer adverse event latency periods. Network pharmacology identified HSP90AA1 as a pivotal therapeutic target, while molecular docking and 100-ns molecular dynamics simulations confirmed the stable binding of each drug to HSP90AA1. In vitro assays demonstrated that HSP90AA1 is significantly overexpressed in breast cancer, driving cell proliferation and invasion, and correlates with a poor prognosis. Furthermore, the triple regimen of trastuzumab, lapatinib, and tanespimycin significantly inhibited the PI3K/Akt/mTOR signaling pathway. This study establishes a novel framework for drug safety evaluation and provides a theoretical rationale for optimizing therapeutic strategies in HER2-positive tumors. These findings highlight the potential advantages of combination therapies regarding AE latency and elucidate the critical role of HSP90AA1.

PMID 42719185
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PubMedClinical cancer research : an official journal of the American Association for Cancer Research2026-09-09

Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial.

Zhang Jin J, Zhu Jinhai J, Yang Yaping Y, Song Dong D et al.

This randomized, double-blind phase 3 equivalence study aimed to evaluate the similarity of neoadjuvant pertuzumab biosimilar HLX11 versus reference pertuzumab plus trastuzumab and docetaxel for human epidermal growth factor receptor 2-positive, hormone receptor-negative early-stage or locally advanced breast cancer (BC). Eligible patients were randomly assigned (1:1) to receive 4 cycles of neoadjuvant HLX11 (HLX11 arm) or European Union-sourced pertuzumab, plus trastuzumab and docetaxel (EU-pertuzumab arm). Patients in the respective arms received adjuvant HLX11 plus trastuzumab or were re-randomized (1:1) to receive HLX11 or EU-pertuzumab plus trastuzumab. The primary endpoint was blinded independent central review (BICR)-assessed total pathological complete response (tpCR) rate. In total, 908 patients were randomized to the HLX11 (n = 454) or EU-pertuzumab arm (n = 454); 192 patients in HLX11 arm received adjuvant HLX11; 200 patients in EU-pertuzumab arm were re-randomized to receive adjuvant HLX11 (n = 100) or EU-pertuzumab (n = 100). BICR-assessed tpCR rate (95% confidence interval [CI]) was 46.3% (41.6%-51.0%) and 45.8% (41.2%-50.5%), respectively. The equivalence criteria were met, with relative risk of tpCR (90% CI) of 1.01 (0.90-1.14) and relative difference (95% CI) of 0.47% (-5.99%-6.92%). No clinically meaningful differences were observed in other efficacy endpoints, safety, pharmacokinetics (PK), or immunogenicity. In the adjuvant phase, switching from EU-pertuzumab to HLX11 led to no notable differences in safety, PK, or immunogenicity. Compared with EU-pertuzumab, neoadjuvant HLX11 demonstrated a similar tpCR rate and no clinically meaningful differences in other efficacy endpoints, safety, PK, or immunogenicity in BC.

PMID 42714872
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PubMedJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026-09-09

Risk-Adapted Optimization of Neoadjuvant Therapy in Human Epidermal Growth Factor Receptor 2-Positive Early-Stage Breast Cancer.

Kleeman Sam O SO, Stearns Vered V

Women with stage II to III human epidermal growth factor receptor 2 (HER2)-positive breast cancer commonly receive neoadjuvant therapy. Recent trials have substantially expanded treatment options for these individuals. Randomized trial data indicate that carboplatin can be safely omitted from neoadjuvant therapy for most patients with stage II HER2-positive early-stage breast cancer, with comparable pathological complete response rates and reduced toxicity. Here, we review evidence supporting de-escalation in the neoadjuvant setting from docetaxel or paclitaxel, carboplatin, trastuzumab, pertuzumab to docetaxel or paclitaxel, trastuzumab, pertuzumab with weekly paclitaxel and examine biomarker-guided strategies for further de-escalation, including chemotherapy-free approaches. DESTINY-Breast11 and DESTINY-Breast05 have established the use of neoadjuvant and postneoadjuvant fam-trastuzumab deruxtecan-nxki, respectively, as new options for high-risk disease, with both indications recently granted approval from the U S Food and Drug Administration. We propose a framework for risk-adapted treatment optimization, highlighting the potential of circulating tumor DNA monitoring and functional imaging as response-adapted strategies and identifying them as priorities for future investigation. Together, these advances support a more precise, individualized approach to caring for patients with early-stage HER2-positive breast cancer.

PMID 42715513
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PubMedClinical cancer research : an official journal of the American Association for Cancer Research2026-09-09

ERBB2 Activating Mutations Promote Enhanced Internalization and Activity of Trastuzumab Deruxtecan in HER2-non-amplified Metastatic Breast Cancer.

Mai Nicholas N, Nag Sharanya S, Liu Bo B, Chen Wanyi W et al.

Trastuzumab Deruxtecan (T-DXd) is a HER2-targeting ADC approved for HER2-positive and HER2-low metastatic breast cancer (MBC). Whether activating mutations in ERBB2 potentiate response to T-DXd in MBC is unknown. Patients who received T-DXd for non-HER2-amplified MBC and had somatic sequencing were eligible. Real-world progression free survival (rwPFS) was calculated using the Kaplan-Meier method. Uni-and multivariable associations were assessed using Cox-proportional hazards models. Activating ERBB2 mutations (per OncoKB) were modeled in breast cell lines and examined for kinetics of T-DXd internalization and potency of antitumor effects. 272 patients received T-DXd for HER2-non-amplified MBC. ERBB2 mutations were found in 20 (7.3%) patients and were associated with prolonged median rwPFS on T-DXd (11 vs 6.2 months for wild-type ERBB2). After adjusting for age, treatment line, ER status, and HER2 IHC, ERBB2 mutations were independently associated with longer rwPFS (HR 0.49, 95%CI 0.25-0.96, p=0.038). Nine patients (45%) with ERBB2 mutations had HER2 IHC 0 disease; no difference in rwPFS was observed between HER2 IHC 1-2+ vs 0 (HR 1.37, 95%CI 0.35-5.34, p=0.7). Expression of common ERBB2 mutants in CAMA-1, T47D, and MCF10A cells lead to more rapid T-DXd internalization (1.3x (L755S, p<0.05 t test) to 1.96x (D769Y,p<0.001 t test )) and lower IC50 (0.017 to 0.070 µg/mL versus 2.86 µg/mL) compared to cells expressing WT HER2. ERBB2 activating mutations are associated with longer T-DXd rwPFS in HER2-non-amplified MBC, even when HER2 IHC was 0. ERBB2 mutant breast cancers are more sensitive to T-DXd, independent of HER2 expression levels.

PMID 42714867
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PubMedJournal of hematology & oncology2026-09-09

Next-generation antibody-based therapeutics in cancer: antibody-drug conjugates bispecific antibodies across hematologic malignancies and solid tumors.

Lou Jiacheng J, Lyu Yizhu Y

The therapeutic paradigm in oncology is undergoing a profound transformation driven by antibody-drug conjugates (ADCs) and bispecific antibodies (bsAbs). This review comprehensively summarizes recent clinical advances of these platforms across both hematologic malignancies and solid tumors. ADCs such as trastuzumab deruxtecan have expanded the concept of targetable HER2 expression, demonstrating meaningful intracranial activity and redefining standards of care in HER2-low breast cancer and beyond. The landscape continues to broaden with novel ADC targets (TROP2, CLDN18.2, B7-H3, HER3) and bispecific ADC constructs. Concurrently, T‑cell-engaging bsAbs-CD20×CD3 in B‑cell lymphomas, BCMA×CD3 and GPRC5D×CD3 in multiple myeloma, and CD19×CD3 in acute lymphoblastic leukemia-have achieved deep and durable responses in heavily pretreated populations. In solid tumors, EGFR‑MET and DLL3‑targeted bsAbs have delivered clinically validated efficacy in historically refractory settings, including regulatory approval of tarlatamab. Despite these successes, critical challenges persist, including the management of unique toxicity profiles, the emergence of resistance via antigen escape and T‑cell exhaustion, and the absence of validated predictive biomarkers. Optimal sequencing of these agents with one another and with chimeric antigen receptor T‑cell therapy remains largely empirical. Next‑generation strategies-bispecific ADCs, probody‑drug conjugates, and immune‑stimulating antibody conjugates-combined with immunotherapy partnerships hold promise for overcoming resistance and improving therapeutic indices. By distilling pivotal clinical data and highlighting unresolved questions, this review provides a roadmap for translating antibody‑based innovations into precision oncology.

PMID 42711696
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