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EU-sourced YERVOY®
YERVOY (ipilimumab) blocks CTLA-4 on T cells, removing an inhibitory signal and enhancing anti-tumor immune responses.
YERVOY (ipilimumab) blocks CTLA-4 on T cells, removing an inhibitory signal and enhancing anti-tumor immune responses. Used for Metastatic melanoma, Advanced renal cell carcinoma, Metastatic colorectal cancer (microsatellite instability-high).
At a glance
| Generic name | EU-sourced YERVOY® |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | CTLA-4 inhibitor |
| Target | CTLA-4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ipilimumab is a monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a negative regulator of T-cell activation. By blocking CTLA-4, the drug removes a 'brake' on the immune system, allowing T cells to proliferate and attack cancer cells more effectively. This checkpoint inhibitor approach has demonstrated clinical benefit across multiple solid and hematologic malignancies.
Approved indications
- Metastatic melanoma
- Advanced renal cell carcinoma
- Metastatic colorectal cancer (microsatellite instability-high)
- Hepatocellular carcinoma
Common side effects
- Immune-related colitis
- Immune-related hepatitis
- Immune-related pneumonitis
- Immune-related endocrinopathy (thyroiditis, hypophysitis)
- Rash
- Fatigue
- Diarrhea
Key clinical trials
- Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (PHASE1)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma (PHASE3)
- A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects (PHASE1)
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 |