Details

Autor(en) / Beteiligte

• Phillips, Adrienne A
• Fields, Paul A
• Hermine, Olivier
• Ramos, Juan C
• Beltran, Brady E
• Pereira, Juliana
• Wandroo, Farooq
• Feldman, Tatyana
• Taylor, Graham P
• Sawas, Ahmed
• Humphrey, Jeffrey
• Kurman, Michael
• Moriya, Junji
• Dwyer, Karen
• Leoni, Mollie
• Conlon, Kevin
• Cook, Lucy
• Gonsky, Jason
• Horwitz, Steven M

Titel

Mogamulizumab versus investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma

Ist Teil von

• Haematologica (Roma), 2019-05, Vol.104 (5), p.993-1003

Ort / Verlag

Italy

Erscheinungsjahr

2019

Quelle

MEDLINE

Beschreibungen/Notizen

• Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and safety of mogamulizumab in ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America. With stratification by subtype, patients were randomized 2:1 to intravenous mogamulizumab 1.0 mg/kg once weekly for 4 weeks and biweekly thereafter (n=47) or investigator's choice of chemotherapy (n=24). The primary end point was confirmed overall response rate (cORR) confirmed on a subsequent assessment at 8 weeks by blinded independent review. ORR was 11% (95%CI: 4-23%) and 0% (95%CI: 0-14%) in the mogamulizumab and chemotherapy arms, respectively. Best response was 28% and 8% in the respective arms. The observed hazard ratio for progression-free survival was 0.71 (95%CI: 0.41-1.21) and, after adjustment for performance status imbalance, 0.57 (95%CI: 0.337-0.983). The most frequent treatment-related adverse (grade ≥3) events with mogamulizumab were infusion-related reaction and thrombocytopenia (each 9%). Relapsed/refractory ATL is an aggressive, poor prognosis disease with a high unmet need. Investigator's choice chemotherapy did not result in tumor response in this trial; however, mogamulizumab treatment resulted in 11% cORR, with a tolerable safety profile.