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Disitamab Vedotin combined with Tislelizumab
Disitamab Vedotin combined with Tislelizumab is a Antibody-drug conjugate combined with PD-1 inhibitor Small molecule drug developed by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. It is currently FDA-approved for HER2-positive gastric or gastroesophageal junction cancer, HER2-positive breast cancer (potential).
Disitamab vedotin delivers a cytotoxic payload to HER2-expressing cancer cells while tislelizumab simultaneously blocks PD-1 to enhance anti-tumor immune response.
Disitamab vedotin delivers a cytotoxic payload to HER2-expressing cancer cells while tislelizumab simultaneously blocks PD-1 to enhance anti-tumor immune response. Used for HER2-positive gastric or gastroesophageal junction cancer, HER2-positive breast cancer (potential).
At a glance
| Generic name | Disitamab Vedotin combined with Tislelizumab |
|---|---|
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Drug class | Antibody-drug conjugate combined with PD-1 inhibitor |
| Target | HER2 (disitamab vedotin); PD-1 (tislelizumab) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Disitamab vedotin is an antibody-drug conjugate (ADC) targeting HER2 that binds to HER2-positive tumor cells and releases a microtubule-disrupting agent intracellularly. Tislelizumab is a humanized PD-1 inhibitor that relieves T-cell exhaustion and promotes anti-tumor immunity. The combination leverages both direct cytotoxic killing and immune checkpoint blockade for enhanced efficacy.
Approved indications
- HER2-positive gastric or gastroesophageal junction cancer
- HER2-positive breast cancer (potential)
Common side effects
- Nausea
- Fatigue
- Diarrhea
- Peripheral neuropathy
- Immune-related adverse events (irAEs)
Key clinical trials
- A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (PHASE3)
- Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC) (PHASE2)
- Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients (PHASE2)
- A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE3)
- First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer (PHASE2)
- Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression (PHASE2)
- A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk. (PHASE2)
- Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Disitamab Vedotin combined with Tislelizumab CI brief — competitive landscape report
- Disitamab Vedotin combined with Tislelizumab updates RSS · CI watch RSS
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology portfolio CI
Frequently asked questions about Disitamab Vedotin combined with Tislelizumab
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Related
- Drug class: All Antibody-drug conjugate combined with PD-1 inhibitor drugs
- Target: All drugs targeting HER2 (disitamab vedotin); PD-1 (tislelizumab)
- Manufacturer: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive gastric or gastroesophageal junction cancer
- Indication: Drugs for HER2-positive breast cancer (potential)
- Compare: Disitamab Vedotin combined with Tislelizumab vs similar drugs
- Pricing: Disitamab Vedotin combined with Tislelizumab cost, discount & access