Poteligeo

Poteligeo (moglizumab injection) is the first biologic targeting CC chemokine receptor 4 (CCR4). It was approved in the United States and the European Union in 2018 for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) who have previously received at least one systemic therapy. Poteligeo is the first drug approved to treat patients with SS and provides a new treatment option for patients with MF.

Poteligeo (moglizumab injection) is a humanized monoclonal antibody targeting CCR4. CCR4 is often expressed on leukemia cells of certain hematological malignancies, including CTCL. Poteligeo was developed using Kyowa Hakko Kirin’s proprietary POTELLIGENT platform, which reduces the fucose component in the sugar chain structure of the antibody, thereby enhancing antibody-dependent cellular cytotoxicity (ADCC).

In China, the marketing application for Poteligeo (moglizumab injection) submitted by Concord Kirin (China) Pharmaceutical Co., Ltd. was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on July 2, 2021.

Mogamulizumab has demonstrated efficacy in many patients with MF and SS. The MAVORIC clinical trial compared mogamulizumab with vorinostat in patients with relapsed or refractory mycosis fungoides or Sézary syndrome and found that patients taking mogamulizumab took more than twice as long to stabilize as those taking the control treatment, vorinostat. The specific performance is the difference in median progression-free survival (progression-free survival) of 7.7 months and 3.1 months, and progression-free survival is the main evaluation criterion of the trial. Medication side effects were similar between the two treatment groups. The MAVORIC trial is the largest clinical trial in CTCL cancer; it enrolled 372 patients at 61 sites in 11 countries (16 sites in Europe and three in the UK).

In August 2018, the US FDA approved Mogamulizumab for the treatment of mycosis fungoides (MF) and Sézary syndrome (SS). This drug has been used in Japan for many years to treat lymphoma patients.