MEDI0562 is an antibody-based immunotherapy that MedImmune is developing as a treatment for  advanced solid tumors and ovarian cancer.

How MEDI0562 works

An antibody is a protein the immune system produces to combat harmful foreign substances called antigens. MEDI0562 promotes an immune response against antigens found on the surface of cancer cells, destroying the cancer cells.

MEDI0562 is a monoclonal antibody, or copy of a natural antibody. It binds with OX40, a receptor on the surface of specialized immune T-cells that fight invaders.

The binding prompts OX40 to help the T-cells survive and multiply. Activating OX40 also prevents regulatory T-cells from suppressing the immune system. Regulatory T-cells suppress the system to prevent it from attacking healthy cells, but the suppression can help cancer cells survive and grow.

MEDI0562 in clinical trials

Advanced solid tumors

An open-label, multicenter Phase 1 clinical trial (NCT02318394) is evaluating MEDI0562’s safety and ability to trigger an immune response in adults with selected advanced solid tumors. The study is also assessing patients’ ability to tolerate the therapy.

The trial has two phases — a dose escalation phase and a dose expansion phase. The first phase is evaluating six levels of MEDI0562 injected into the bloodstream, with different trial participants receiving different doses. Researchers are assessing patients’ tumors every eight weeks to see how they respond to the various doses.

In the second part of the trial, patients’ doses are increased over time. Preliminary data from the dose escalation phase showed that the 27 patients tolerated the therapy well and that it displaying signs of effectiveness against advanced solid tumors.

The trial is continuing in the United States and Korea but no longer recruiting participants.

Another open-label, multicenter Phase 1 trial (NCT02705482) is recruiting adults with advanced solid tumors in the United States, Australia, France, and the Netherlands.

It will evaluate the safety and effectiveness of a combination of MEDI0562 and one of two other monoclonal antibodies — either Imfinzi (durvalumab) or tremelimumab. Imfinzi targets the PD-L1 protein  and tremelimumab the CTLA-4 protein on the surface of cancer cells.

This study also has two phases — a dose escalation and a dose expansion phase. Each phase has two treatment arms. One group will receive a combination of MEDI0562 and Imfinzi, and the other a combination of MEDI0562 and tremelimumab. The study is expected to be completed by 2023.

Ovarian cancer

A Phase 2 trial (NCT03267589) aims to evaluate the safety and effectiveness of a combination of MEDI0562 and either Imfinzi or tremelimumab as a treatment for ovarian cancer that has returned. Recruitment has yet to start for this trial, which will take place in Denmark, Finland, and Norway. The study is expected to be completed by 2022.


Immuno-Oncology News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.