Overview
Disitamab vedotin is an antibody-drug conjugate drug targeting human epidermal growth factor receptor 2 (HER2). It is currently being investigated for cancers.
Indication
用于至少接受过2个系统化疗的HER2过表达局部晚期或转移性胃癌（包括胃食管结合部腺癌）的患者，HER2过表达定义为HER2免疫组织化学检查结果为2+或3+。
Associated Conditions
No associated conditions information available.
Research Report
Disitamab Vedotin (RC48): A Comprehensive Analysis of a Novel HER2-Targeted Antibody-Drug Conjugate
Executive Summary
Disitamab vedotin (also known as RC48 and marketed as Aidixi®) is a novel, investigational antibody-drug conjugate (ADC) poised to make a significant impact on the treatment landscape for human epidermal growth factor receptor 2 (HER2)-expressing cancers. Developed by RemeGen and now a key asset in Pfizer's oncology portfolio following its acquisition of Seagen, disitamab vedotin is distinguished by its unique molecular design. It combines a novel anti-HER2 monoclonal antibody, hertuzumab, which binds to a distinct epitope with higher affinity than trastuzumab, with the potent microtubule inhibitor monomethyl auristatin E (MMAE) via a cleavable linker. This construction facilitates a powerful bystander effect, enabling the treatment of tumors with heterogeneous or low levels of HER2 expression.
Extensive clinical trials have demonstrated robust and clinically meaningful efficacy across multiple solid tumors. In urothelial carcinoma, disitamab vedotin has shown a 50.5% objective response rate (ORR) as a monotherapy in heavily pretreated patients and an impressive 73.2% ORR with a median overall survival (OS) of 33.1 months when combined with a PD-1 inhibitor. In gastric cancer, it is the first HER2-targeted therapy to show significant activity in the HER2-low population, a large and underserved segment. In breast cancer, disitamab vedotin has proven effective in both HER2-positive and HER2-low settings and shows promise in preclinical models resistant to the current standard-of-care, trastuzumab deruxtecan (Enhertu).
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/11 | Phase 1 | Not yet recruiting | |||
2025/05/04 | Phase 1 | Not yet recruiting | Sun Yat-sen University | ||
2025/04/01 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2024/12/12 | Phase 2 | Recruiting | |||
2024/10/29 | Phase 1 | Recruiting | Tianjin Medical University Second Hospital | ||
2024/10/21 | Phase 1 | Recruiting | |||
2024/10/15 | Phase 2 | Recruiting | |||
2024/08/20 | Phase 2 | Recruiting | |||
2024/07/09 | Phase 2 | Not yet recruiting | The First Affiliated Hospital of Zhengzhou University | ||
2024/04/29 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Disitamab Vedotin For Injection | 国药准字S20237006 | 生物制品 | 注射剂 | 8/21/2023 | |
| Disitamab Vedotin For Injection | 国药准字S20210017 | 生物制品 | 注射剂 | 6/8/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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