Phase III MAVORIC trial analyses of Poteligeo shows impact of therapy in T-cell lymphoma.- Kyowa Kirin

Kyowa Kirin announced data from two post-hoc analyses of the pivotal open-label, international, Phase III, randomized controlled MAVORIC trial of Poteligeo (mogamulizumab) versus standard-of-care vorinostat in patients with previously treated mycosis fungoides (MF), or Sézary syndrome (SS), the two most common types of cutaneous T-cell lymphoma (CTCL). The first evaluated the clinical and demographic characteristics of mogamulizumab-treated patients based on their duration of overall response (ORR), while the second explored the characteristics of patients who experienced mogamulizumab-associated rash. The findings showed patients who achieved a long-term (> 12 months) response with mogamulizumab treatment were more likely to have Sézary syndrome (stage IVA1) or blood involvement compared to patients with an ORR of shorter duration. Further, among those who experienced treatment-related rash (n=44), the data show 80% were able to continue treatment for >6 months following the resolution of initial rash. Among patients randomized to mogamulizumab (n=186), ORRs lasting at least 4, 6, 8, and 12 months were seen in 25.3%, 21.0%, 16.1%, and 10.8%, respectively. Mogamulizumab treatment resulted in significantly higher long-term overall response rates in both blood and skin measures compared to vorinostat. Responses in blood and skin lasting at least 6 months were seen in 49.2% and 27.4% of mogamulizumab-treated patients, respectively, compared with 5.6% and 7.5% with vorinostat. When compared with patients with shorter responses, patients who achieved long-term responses were more likely to have SS (stage IVA1) or blood involvement. A post-hoc analysis shows that among mogamulizumab-treated patients, 24% (44/184) reported treatment-emergent rash, the majority Grade 1/2, leading to discontinuation in 13 patients. Patients who experienced mogamulizumab-associated rash were more likely to be diagnosed with SS (25/44, 56.8%) than MF (19/44, 43.2%). The proportion of patients with SS who responded to mogamulizumab and experienced rash (14/25, 56%) was significantly higher than the proportion of responders without rash (16/54, 30%) (P=0.02). Overall, 80% of patients (35/44) were able to continue treatment with a median duration of exposure of >6 months after resolution of their initial rash. Data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting.