Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma
Top Cited Papers
- 1 June 2007
- journal article
- research article
- Published by American Society of Hematology in Blood
- Vol. 109 (11), 4655-4662
- https://doi.org/10.1182/blood-2006-12-062877
Abstract
The efficacy and safety of zanolimumab in patients with refractory cutaneous T-cell lymphoma (CTCL) have been assessed in two phase 2, multicenter, prospective, open-label, uncontrolled clinical studies. Patients with treatment refractory CD4+ CTCL (mycosis fungoides [MF], n = 38; Sézary syndrome [SS], n = 9) received 17 weekly infusions of zanolimumab (early-stage patients, 280 and 560 mg; advanced-stage patients, 280 and 980 mg). The primary end point was objective response (OR) as assessed by composite assessment of index lesion disease activity score. Secondary end points included physician's global assessment (PGA), time to response, response duration, and time to progression. ORs were recorded for patients in both CTCL types (MF, 13 ORs; SS, 2 ORs). In the high-dose groups (560 and 980 mg dose groups), a response rate of 56% was obtained with a median response of 81 weeks. Adverse events reported most frequently included low-grade infections and eczematous dermatitis. Zanolimumab showed marked clinical efficacy in the treatment of patients with refractory MF, with early onset of response, high response rate, and durable responses. The treatment was well tolerated with no dose-related toxicity other than the targeted depletion of peripheral T cells. A pivotal study has been initiated based on these findings.This publication has 27 references indexed in Scilit:
- WHO-EORTC classification for cutaneous lymphomasBlood, 2005
- Cutaneous T-cell lymphoma: malignant proliferation of T-regulatory cellsBlood, 2005
- CD4+CD25+regulatory T cells: I. Phenotype and physiologyAPMIS, 2004
- Profound loss of T-cell receptor repertoire complexity in cutaneous T-cell lymphomaBlood, 2003
- Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sézary syndromeBlood, 2003
- Treatment of refractory rheumatoid arthritis with a chimeric ANTI‐CD4 monoclonal antibodyArthritis & Rheumatism, 1994
- Lymphocyte subsets in the blood: a diagnostic window on the lymphoid system?Immunology Today, 1990
- Phenotype, Ultrastructure, and Function of CD1+DR+ Epidermal Cells that Express CD36 (OKM5) in Cutaneous T‐Cell LymphomaScandinavian Journal of Immunology, 1990
- Cutaneous T-Cell Lymphoma Lesional Epidermal Cells Activate Autologous CD4+ T Lymphocytes: Involvement of Both CD1+OKM5+ and CD1+OKM5− Antigen-Presenting CellsJournal of Investigative Dermatology, 1990
- Expression of OKM5 Antigen on Epidermal Cells in Mycosis Fungoides Plaque StageJournal of Investigative Dermatology, 1988