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Non-Hodgkin Lymphoma
Mogamulizumab versus investigator’s choice of chemotherapy regimen in relapsed/ refractory adult T-cell leukemia/lymphoma
Ferrata Storti Foundation
Haematologica 2019 Volume 104(5):993-1003
Adrienne A. Phillips,1 Paul A. Fields,2 Olivier Hermine,3 Juan C. Ramos,4 Brady E. Beltran,5 Juliana Pereira,6 Farooq Wandroo,7 Tatyana Feldman,8 Graham P. Taylor,9 Ahmed Sawas,10 Jeffrey Humphrey,11 Michael Kurman,11 Junji Moriya,11 Karen Dwyer,11 Mollie Leoni,11 Kevin Conlon,12 Lucy Cook,13 Jason Gonsky14 and Steven M. Horwitz;15 on behalf of the 0761-009 Study Group
1Division of Hematology and Medical Oncology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, USA; 2Department of Haematology Guy's and St Thomas' Hospitals NHS Trust Hospital, London, UK; 3Department of Hematology, Necker University Hospital, Paris, France; 4Division of Hematology/Oncology, University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, FL, USA; 5Hospital Nacional Edgardo Rebagliati Martins and Centro de Investigación de Medicina de Precision, Universidad de San Martin de Porres, Lima, Peru; 6Department of Hematology, University of São Paulo, Brazil; 7Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, and University of Birmingham, UK; 8John Theurer Cancer Center, Hackensack UMC, NJ, USA; 9National Centre for Human Retrovirology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK; 10Center for Lymphoid Malignancies, Columbia University Irving Medical Center, New York, NY, USA; 11Kyowa Kirin, Princeton, NJ, USA; 12Warren Grant Magnuson Clinical Center, National Cancer Institute, Bethesda, MD, USA; 13Department of Haematology and National Centre for Human Retrovirology, Imperial College Healthcare NHS Trust, London, UK; 14Division of Hematology/Oncology, Department of Medicine, New York City Health + Hospitals/Kings County and SUNY Downstate Medical Center, Brooklyn, NY, USA and 15Hematology/ Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
ABSTRACT
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 stratifica- tion by subtype, patients were randomized 2:1 to intravenous moga- mulizumab 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 sub- sequent assessment at 8 weeks by blinded independent review. ORR was 11% (95%CI: 4-23%) and 0% (95%CI: 0-14%) in the moga- mulizumab and chemotherapy arms, respectively. Best response was 28% and 8% in the respective arms. The observed hazard ratio for pro- gression-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 thrombocy- topenia (each 9%). Relapsed/refractory ATL is an aggressive, poor prog- nosis disease with a high unmet need. Investigator’s choice chemother- apy did not result in tumor response in this trial; however, moga- mulizumab treatment resulted in 11% cORR, with a tolerable safety profile. Trial registered at clinicaltrials.gov identifier: 01626664.
Correspondence:
ADRIENNE A. PHILLIPS adp9002@med.cornell.edu
Received: August 22, 2018. Accepted: December 18, 2018. Pre-published: December 20 2018.
doi:10.3324/haematol.2018.205096
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/104/5/993
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