In a recent news release from global specialty pharmaceutical company Kyowa Kirin International PLC (“Kyowa Kirin”), the company announced the release of new real-world data on POTELIGEO (mogamulizumab) for patients with cutaneous T-cell lymphoma (CTCL). Previously, the therapy had been studied within the Phase 3 MAVORIC clinical trial for mycosis fungoides (MF) and Sézary syndrome (SS), which are CTCL subtypes. While there was a response seen in the trial, real-world study data suggests a significantly higher response rate than once believed.
To begin, what exactly is POTELIGEO? According to Kyowa Kirin, POTELIGEO is:
a humanized monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including cutaneous T-cell lymphomas (CTCL). By binding to CCR4 on malignant T-Cells, POTELIGEO® elicits an anti-tumor activity mediated by antibody-dependent cellular cytotoxicity (ADCC) leading to the death of malignant T-Cell.
Kyowa Kirin developed POTELIGEO using its proprietary POTELLIGENT platform. The therapy is delivered intravenously.
Within the Phase 3 MAVORIC clinical trial, researchers evaluated the safety, efficacy, and tolerability of POTELIGEO for patients with MF and SS who had been on at least one prior therapy. Additionally, the trial compared POTELIGEO to vorinostat for treatment. Altogether, the trial saw an overall response rate of 35%. While the treatment was relatively safe and well-tolerated, some adverse reactions did occur, including infusion-related reactions and rashes.
However, researchers also wanted to explore how the drug worked in a real-life setting. In fact, the results seemed even more promising. Altogether, researchers collected data from 124 patients with CTCLs who were treated with POTELIGEO over a 6-year period. Findings include:
- The overall response rate in the real-life study was 58.5%, a full 23.5% higher than the trial response rate.
- There was a slight difference in overall response between patients with MF (47%) and patients with SS (68.3%). However, this was still greater than the trial, with MF (21%) and SS (37%).
- Similarly to the trial, the real-world data showed that POTELIGEO was relatively safe and well-tolerated. Side effects and adverse reactions included rashes, infusion-related reactions, muscle weakness or general malaise, and low lymphocyte levels.
Cutaneous T-Cell Lymphoma (CTCL)
There are numerous types of cutaneous T-cell lymphomas (CTCLs), disorders characterized by abnormal malignant T-cell buildup in the skin. MF and SS are the two most common forms of CTCL. Others include subcutaneous panniculitic T-cell lymphoma, lymphomatoid papulosis, and granulomatous slack skin. CTCL may appear as tumors, skin plaques, rashes, or other cutaneous manifestations. Patients with mycosis fungoides experience three stages: patch (nonspecific dermatitis), plaque (very itchy plaques and swollen lymph nodes), and tumors which are prone to ulcers. Alternately, symptoms of SS include:
- Nail dystrophy
- Swollen or puffy skin that may appear stretched or shiny
- Plantar hyperkeratosis (corns, calluses)
- Enlarged liver and spleen
- Thickened skin on the palms or soles
- Skin tumors
- Rash which can cover up to 80% of the body