In short
Atebimetinib is an investigational oral drug being studied in a Phase 3 trial for metastatic pancreatic ductal adenocarcinoma. The trial, MAPKeeper 301, is evaluating whether atebimetinib combined with gemcitabine and nab-paclitaxel can help people live longer compared to gemcitabine and nab-paclitaxel alone. It plans to enrol 510 participants and is currently authorised but not yet recruiting.
Key points
- Atebimetinib is an investigational oral drug, not yet an authorised medicine.
- It is being tested in a Phase 3 trial for metastatic pancreatic ductal adenocarcinoma.
- The trial compares atebimetinib plus gemcitabine/nab-paclitaxel against gemcitabine/nab-paclitaxel alone.
- 510 participants are planned for enrolment.
- The main measure is overall survival — time from randomisation to death from any cause.
- The trial is currently authorised, meaning it has regulatory approval but is not yet recruiting.
What is atebimetinib?
Atebimetinib is an investigational substance, meaning it is not yet authorised as a medicine. It is being studied in oncology, specifically for metastatic pancreatic ductal adenocarcinoma. The substance is given as an oral formulation, with a dose of 320 mg used in the trial. No trade names or other development codes for atebimetinib are provided in the registry data.
How does atebimetinib work?
The registry data does not describe the mechanism of action of atebimetinib in detail. It is being tested in combination with gemcitabine and nab-paclitaxel, two chemotherapy drugs used to treat pancreatic cancer. The trial is designed to evaluate whether adding atebimetinib to this chemotherapy combination improves overall survival.
Which conditions is atebimetinib studied for?
- Metastatic pancreatic ductal adenocarcinoma — a type of pancreatic cancer that has spread to other parts of the body. This is the only condition listed in the trial registry for atebimetinib.
How is atebimetinib given?
Atebimetinib is given orally, as a tablet or capsule, at a dose of 320 mg in the trial. The chemotherapy drugs gemcitabine and nab-paclitaxel are given intravenously: gemcitabine at 1000 mg per square metre of body surface area, and nab-paclitaxel at 125 mg per square metre. Atebimetinib is added to this intravenous chemotherapy as an oral drug.
What do the clinical trials show?
There is one registered clinical trial of atebimetinib, identified as NCT07562152 and titled MAPKeeper 301. It is a Phase 3 trial, the most advanced stage of clinical testing before a drug can be considered for marketing approval. The trial is currently authorised, meaning it has received regulatory approval to proceed but is not yet recruiting participants.
The trial plans to enrol 510 participants with metastatic pancreatic ductal adenocarcinoma. Participants will be randomly assigned to receive either atebimetinib plus modified gemcitabine and nab-paclitaxel, or gemcitabine and nab-paclitaxel alone. The main outcome measure is overall survival, defined as the time from randomisation to the date of death from any cause.
Because the trial is not yet recruiting, no results are available. The registry record provides only the study design and planned outcomes.
What side effects are known?
No side effect information for atebimetinib is provided in the available sources. As an investigational drug in a trial that has not yet begun recruiting, safety data will be collected during the study.