Mogamulizumab versus investigator’s choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma
Open accessAbstract
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.
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Mogamulizumab targets CCR4, a chemokine receptor highly expressed by HTLV-1-infected T cells, with phase I and II clinical trials resulting in an overall response rate (ORR) of 50%.
“Mogamulizumab targets CCR4, a chemokine receptor highly expressed by HTLV-1-infected T cells [198,199,200], with phase I and II clinical trials resulting in an overall response rate (ORR) of 50% [201,202,203].”
From Current State of Therapeutics for HTLV-1 (2024) · cites this paper as [202]
The Introduction reports a 50% ORR in a prior Japanese phase II trial, but does not attribute that rate to phase I trials. The Discussion (p. 999) distinguishes that earlier result from this paper’s own phase II trial, which found an 11% confirmed ORR. (LLM, conf=0.90)
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Self-citation
- Authors
- Phillips, A. A., Fields, P. A., Hermine, O., Ramos, J. C., Beltran, B. E., Pereira, J., Wandroo, F., Feldman, T., Taylor, G. P., Sawas, A., Humphrey, J., Kurman, M., Moriya, J., Dwyer, K., Leoni, M., Conlon, K., Cook, L., Gonsky, J., & Horwitz, S. M.
- Affiliations
- NewYork–Presbyterian Hospital (US)
- Guy's Hospital (GB)
- Hôpital Necker-Enfants Malades (FR)
- University of Miami (US)
- Universidade de São Paulo (BR)
- Sandwell & West Birmingham Hospitals NHS Trust (GB)
- Hackensack University Medical Center (US)
- Imperial College Healthcare NHS Trust (GB)
- Columbia University Irving Medical Center (US)
- Kyowa Kirin (United States) (US)
- National Cancer Institute (US)
- State University of New York (US)
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Phillips, Adrienne A.
- ORCID
- Venue
- Haematologica
- Published
- 2018-12-20
- Volume
- 104
- Issue
- 5
- Pages
- 993-1003
- ISSN
- 0390-6078 (ISSN-L)
- 1592-8721
- PMC
- PMC6518882
- OpenAlex
- W2905627019
- Cited by
- 70
- References
- 40
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 8 · 2023: 8 · 2022: 9 · 2021: 10 · 2020: 15 · 2019: 9
- FWCI
- 3.65
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Haematologica (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- National Institutes of Health (CA008748, NIH/NCI Cancer Center Support Grant P30 CA008748)
- National Cancer Institute (Grant P30-CA008748, CA008748, NIH/NCI Cancer Center Support Grant P30 CA008748., Support Grant P30 CA008748, P30CA008748)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and Retrovirus Studies
- Health Sciences › Medicine › Dermatology › Cutaneous lymphoproliferative disorders research
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- mogamulizumab, adult T-cell leukemia/lymphoma, relapsed/refractory disease, CCR4, chemotherapy comparison, overall response rate, progression-free survival, infusion reactions, thrombocytopenia, treatment safety
- MeSH terms
- Oxaliplatin, Gemcitabine, Adult, Aged, Aged, 80 and over, Aminopterin, Antineoplastic Combined Chemotherapy Protocols, Cisplatin, Cytarabine, Deoxycytidine, Dexamethasone, Female, Follow-Up Studies, Humans, International Agencies, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Retrospective Studies, Leukemia-Lymphoma, Adult T-Cell, Survival Rate, Salvage Therapy, Drug Resistance, Neoplasm, Young Adult, Antibodies, Monoclonal, Humanized
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