Mogamulizumab is an investigative immunotherapy being developed by Kyowa Hakko Kirin (KHK), of Japan, to treat patients with certain advanced cancers who have no other suitable treatment options.

How mogamulizumab works

Mogamulizumab is a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), a protein present on the surface of some T-cells (specialized immune system cells), endothelial cells (cells that form the inner lining of blood vessels), and nerve cells. A type of cytokine, a chemokine is a small molecule that sends signals that help guide the movement of immune cells.

When mogamulizumab binds to CCR4, it blocks chemokine signals to interfere with immune cell migration and the multiplication of T-cells. It may also stimulate the immune system to attack and kill CCR4-positive T-cells, which makes it a potential treatment for T-cell lymphomas that express CCR4.

Mogamulizumab in clinical trials

Five clinical trials testing mogamulizumab in patients with advanced cancers are currently underway. All are open-label, early phase trials to find how safe mogamulizumab is, alone or in combination with other drugs, and to determine the highest dose that can be safely administered to patients (often called the maximum tolerated dose, or MTD).

Once a maximum dose is determined, some patients will be asked to participate in an expansion study to evaluate the drug’s safety, movement in the body, and potential anti-tumor activity.

Kyowa Hakkko Kirin is collaborating with Pfizer in a Phase 1b/Phase 2 trial (NCT02444793) to test mogamulizumab in combination with PF-F05082566, an monoclonal antibody also targeting certain T-cell receptors. The study will include about 70 patients with advanced or metastatic solid tumors, including certain cancers of the lung, colon, breast, and ovaries, that have not responded to standard therapies.

The study began in May 2015 and is expected to finish in January 2018.

In a second trial (NCT02705105), mogamulizumab is being tested in combination with Opdivo (nivolumab), a collaboration between KHK and Bristol Myers Squib. The Phase 1/Phase 2 trial, expected to run through March 2018, aims to enroll about 188 patients with advanced solid tumors.

A randomized Phase 1 trial ( NCT02301130) that assess mogamulizumab and Imfinzi (durvalumab) in combination against mogamulizumab with tremelimumab about 81 adults with advanced solid tumors. This trial expects to finish in May 2018.

A fourth trial, sponsored by Memorial Sloan Kettering Cancer Center in collaboration with KHK (NCT02281409), is testing mogamulizumab alone in patients whose solid tumors  are unresectable,  meaning that surgeons are unable to remove them. Patients will receive mogamulizumab as an injection into the bloodstream once a week for four weeks; those who tolerate the drug well may continue to receive it weekly for up to 12 months, then every other week after that. This trial, set to finish in October 2018, expects to enroll about 72 patients.

Finally, in a Phase 1 dose-escalation trial (NCT02867007), mogamulizumab in combination with KHK2455, another monoclonal antibody drug being developed by KHK, is being tested against KHK2455 alone. The study, set to finish in 2019, expects to enroll about 50 adults with locally advanced or metastatic solid tumors.  

All ongoing clinical studies of mogamulizumab are still recruiting participants.

 Additional information

Mogamulizumab is already marketed in Japan for the treatment of CCR4-positive adult T-cell lymphoma (ATL), a rare form of non-Hodgkin’s lymphoma with a poor prognosis, and peripheral T-cell lymphoma (PTCL), and cutaneous T-cell lymphoma. It is under evaluation in T-cell lymphomas in the U.S. and Europe — including in a Phase 3 study (NCT01728805) taking place on both continents and Japan in advanced cutaneous T-cell lymphoma (CTCL) patients — but is still classed as an investigational therapy.

The most significant adverse effects of mogamulizumab have been skin reactions.


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