Brenetafusp
Brenetafusp is an investigational medicinal product. No trial currently registered in Europe lists it – that can change as new trials are authorised, and it may be under study elsewhere.
About the substance
Table of contents
- What is brenetafusp?
- How does brenetafusp work?
- Which conditions is brenetafusp being studied for?
- How is brenetafusp given?
- What do the clinical trials show?
- What side effects are known?
What is brenetafusp?
Brenetafusp (also known by the development code IMC-F106C) is an investigational cancer medicine. It is being studied in clinical trials for advanced melanoma and other solid tumours. In these registry records, brenetafusp has no marketing authorisation and is still an investigational substance.
How does brenetafusp work?
Brenetafusp is being studied in cancers that are positive for PRAME, a protein found on the surface of some tumour cells. The available registry records describe its development in PRAME-positive cancers but do not provide further detail on its mechanism of action.[1]
Which conditions is brenetafusp being studied for?
- Advanced melanoma — a type of skin cancer that has spread or cannot be removed by surgery. The Phase 3 trial is testing brenetafusp in people who have not yet received treatment for advanced melanoma.[2]
- Advanced PRAME-positive cancers — solid tumours that carry the PRAME protein. The Phase 1/2 trial studied brenetafusp as a single treatment in selected advanced solid tumours.[1]
How is brenetafusp given?
The Phase 1/2 trial investigated brenetafusp given both intravenously (into a vein) and subcutaneously (under the skin), as a single treatment and in combination with other medicines.[1]
What do the clinical trials show?
Two trials of brenetafusp are listed in the registry. The larger is a Phase 3 trial in 827 people with previously untreated advanced melanoma. It compares brenetafusp plus nivolumab against nivolumab-based regimens, with progression-free survival (the time a person lives without their cancer getting worse) as the main measure.[2]
The earlier trial was a Phase 1/2 study in 104 people with advanced PRAME-positive cancers. Its Phase 1 part aimed to assess safety, tolerability, and to find the maximum tolerated dose and the recommended Phase 2 dose of brenetafusp given intravenously, subcutaneously, and in combination. Its Phase 2 part aimed to characterise early efficacy in selected advanced solid tumours. This trial is now completed.[1]
The Phase 3 trial is currently authorised, meaning it has received regulatory approval to proceed but has not yet reported results.
What side effects are known?
No side effect data for brenetafusp are provided in the available registry records.