Kyowa Kirin: New Data Analysis Shows Link between Blood Involvement and Response to Treatment in Cutaneous T-cell Lymphoma (CTCL) Patients

Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced a new analysis of data showing statistically significant improvements in quality of life in cutaneous T-cell lymphoma (CTCL) patients treated with mogamulizumab with blood involvement, compared to vorinostat. The new findings from the MAVORIC trial compared the impact of treatment with POTELIGEO® (mogamulizumab) and vorinostat by patient blood tumour burden in adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

Professor Doctor Pier Luigi Zinzani of the Institute of Hematology "L. e A. Seràgnoli" at the University of Bologna said: “This new analysis helps us to understand more about the importance of blood involvement in CTCL, which is relatively common in the more advanced stages of the disease and may be present in some less advanced cases. We know that increasing levels of malignant T-cells in the blood correlate with increased risk of CTCL disease progression and an overall reduction in patient survival. Treatment with mogamulizumab has also been shown to be more effective in CTCL patients who have blood involvement as part of their disease and treatment with mogamulizumab also generates quality of life benefits for CTCL patients with blood involvement. This new information underlines the importance of blood monitoring in the clinical management of CTCL patients.”

In the study, patients classified as B0 were considered to have no blood involvement and patients classified as B1 and B2 were considered to have blood involvement.1 B1 is a measurable low level of blood involvement of between 250 to 1000 abnormal T-cells per µL. B2 is higher level of blood involvement, greater than 1000 abnormal T-cells per µL, detected using flow cytometry.

Statistically significant differences in quality of life were seen for patients with blood involvement, with patients treated with mogamulizumab seeing improvements in the Skindex-29 and ItchyQoL questionnaires, compared to vorinostat. Quality of life improvements were also seen in patients treated with mogamulizumab with blood involvement assessed by the Pruritus Likert Scale and the FACT-G Total Score questionnaires, compared to vorinostat. For patients with no blood involvement there was no statistically significant differences in quality of life between mogamulizumab and vorinostat.

MF and SS are subtypes of CTCL, a rare type of non-Hodgkin's lymphoma that can affect the skin, blood, lymph nodes and internal organs.2 As a chronic and generally incurable disease associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.1 MAVORIC is the largest multinational, randomised, Phase 3 trial of systemic CTCL therapy. MAVORIC evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients who had received at least one previous systemic therapy.3 This new post hoc analysis of the MAVORIC trial looked at data from patients’ quality of life using a range of recognised and validated assessment tools.

The MAVORIC trial met its primary endpoint of overall investigator-assessed progression-free survival (PFS), which was shown to be significantly greater for patients treated with mogamulizumab compared to vorinostat, at 7.7 months and 3.1 months, respectively (P<0.0001).3