Study 0761-009: mogamulizumab against investigator's choice in relapsed adult T-cell leukaemia/lymphoma

A randomised trial of mogamulizumab in adult T-cell leukaemia/lymphoma outside Japan, in patients of Caribbean, African and Latin American origin treated in the United States, Europe and Latin America. Patients with relapsed or refractory aggressive disease, stratified by subtype, were randomised 2:1 to mogamulizumab 1.0 mg/kg weekly for four weeks and then every two weeks (47 patients) or to the investigator's choice of chemotherapy (24). The primary endpoint was overall response confirmed on a second assessment eight weeks later by blinded independent review.

Confirmed overall response was 11 per cent (95 per cent confidence interval 4 to 23) with mogamulizumab and 0 per cent (0 to 14) with chemotherapy; best response was 28 and 8 per cent. The hazard ratio for progression-free survival was 0.71 (0.41 to 1.21), and 0.57 (0.337 to 0.983) after a post hoc adjustment for an imbalance in performance status. The commonest grade 3 or worse treatment-related adverse events with mogamulizumab were infusion-related reaction and thrombocytopenia, 9 per cent each.