Overview
Tremelimumab, formerly known as ticilimumab, is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances T cell-mediated killing of tumours and reduces tumour growth. Because CTLA-4 is an immune checkpoint that plays a vital role in regulating T cell-mediated immune response, tremelimumab is considered an immune checkpoint inhibitor, which is an emerging cancer immunotherapy drug class. Tremelimumab was first approved by the FDA in October 2022 to be used in combination with durvalumab to treat hepatocellular carcinoma. It is also being investigated in other cancers, such as colon cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), and malignant melanoma. After receiving an EMA Committee for Medicinal Products for Human Use (CHMP) recommendation in December 2022, tremelimumab was approved for combined use with durvalumab.
Indication
Tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma in combination with durvalumab. It is also indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
- Unresectable Hepatocellular Carcinoma (HCC)
Research Report
Tremelimumab (Imjudo®): A Comprehensive Oncological and Pharmacological Review of a CTLA-4-Targeting Immunotherapy
Executive Summary
Tremelimumab, marketed as Imjudo®, represents a significant advancement in the field of immuno-oncology, embodying a story of scientific resilience and strategic evolution. This report provides an exhaustive analysis of Tremelimumab, a fully human immunoglobulin G2 (IgG2) monoclonal antibody that functions as an immune checkpoint inhibitor by targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Initially developed by Pfizer, Tremelimumab's journey was marked by early clinical trial failures as a monotherapy, leading to its transfer to AstraZeneca. Under a revised strategy, Tremelimumab was repositioned as a combination agent, a move that unlocked its therapeutic potential and led to its current success.
The primary mechanism of action involves blocking the inhibitory CTLA-4 pathway on T-cells, thereby releasing a crucial "brake" on the immune system and priming it for a more robust anti-tumor response. A key differentiator from its first-in-class predecessor, ipilimumab, is its IgG2 isotype, which confers minimal antibody-dependent cell-mediated cytotoxicity (ADCC), a characteristic that likely contributes to a more manageable safety profile in combination regimens.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/14 | Not Applicable | Not yet recruiting | |||
2025/07/23 | Not Applicable | Not yet recruiting | |||
2025/05/31 | Phase 2 | Not yet recruiting | Chang Gung Memorial Hospital | ||
2025/05/31 | Phase 2 | Recruiting | Chang Gung Memorial Hospital | ||
2025/05/29 | Phase 2 | Not yet recruiting | |||
2025/04/10 | Phase 3 | Recruiting | |||
2025/03/03 | Phase 2 | Not yet recruiting | Mehmet Akce | ||
2025/02/13 | Early Phase 1 | Not yet recruiting | |||
2024/11/29 | Phase 1 | Recruiting | |||
2024/11/20 | Phase 2 | Recruiting | Anwaar Saeed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | 0310-4535 | INTRAVENOUS | 300 mg in 15 mL | 10/21/2022 | |
| AstraZeneca Pharmaceuticals LP | 0310-4505 | INTRAVENOUS | 25 mg in 1.25 mL | 10/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/20/2023 | ||
Authorised | 2/20/2023 | ||
Authorised | 2/20/2023 | ||
Authorised | 2/20/2023 | ||
Withdrawn | 2/20/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IMJUDO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML | SIN16845P | INFUSION, SOLUTION CONCENTRATE | 20 mg/mL | 8/25/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| IMJUDO tremelimumab 300 mg/ 15 mL concentrated injection vial | 387300 | Medicine | A | 6/23/2023 | |
| IMJUDO tremelimumab 25 mg/ 1.25 mL concentrated injection vial | 387299 | Medicine | A | 6/23/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| IMJUDO | astrazeneca canada inc | 02541009 | Solution - Intravenous | 20 MG / ML | 10/23/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IMJUDO 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1221713002 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.