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

• Autores: 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.
• Formato: artículo
• Fecha de Publicación: 2019
• Institución: Universidad de San Martín de Porres
• Repositorio: USMP-Institucional
• Lenguaje: inglés
• OAI Identifier: oai:repositorio.usmp.edu.pe:20.500.12727/6237
• Enlace del recurso: https://hdl.handle.net/20.500.12727/6237; https://doi.org/10.3324/haematol.2018.205096
• Nivel de acceso: acceso abierto
• Materia: Aminopterina; Anticuerpos monoclonales humanizados; Protocolos de quimioterapia combinada antineoplásica; Cisplatino; Resistencia a medicamentos; Resistencia a antineoplásicos; https://purl.org/pe-repo/ocde/ford#3.02.00

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 post hoc 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.