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Blood, 1 June 2007, Vol. 109, No. 11, pp. 4655-4662.
Prepublished online as a Blood First Edition Paper on February 20, 2007; DOI 10.1182/blood-2006-12-062877.
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Submitted December 14, 2006
Accepted February 2, 2007
Clinical efficacy of zanolimumab (HuMax-CD4): two Phase II studies in refractory cutaneous T-cell lymphoma
Youn H. Kim*, Madeleine Duvic, Erik Obitz, Robert Gniadecki, Lars Iversen, Anders Osterborg, Sean Whittaker, Timothy M Illidge, Thomas Schwarz, Roland Kaufmann, Kevin Cooper, Kim M Knudsen, Steen Lisby, Ole Baadsgaard, and Susan J Knox
Multidisciplinary Cutaneous Lymphoma Program, Stanford Comprehensive Cancer Center, Stanford, CA, United States
MD Anderson Cancer Center, Houston, TX, United States
Aarhus University Hospital, Aarhus, Denmark
Bispebjerg Hospital, Copenhagen, Denmark
Karolinska Hospital, Stockholm, Sweden
St. Thomas' Hospital, London, United Kingdom
Manchester University, Christie Hospital, Manchester, United Kingdom
Department of Dermatology, University Kiel, Kiel, Germany
Universitatshautklinik, Frankfurt, aM, Germany
Case Western Reserve University Hospital of Cleveland, Cleveland, OH, United States
Genmab A/S, Copenhagen, Denmark
Department of Radiation Oncology, Stanford Comprehensive Cancer Center, Stanford, CA, United States
* Corresponding author; email: younkim{at}stanford.edu.
The efficacy and safety of zanolimumab (HuMax-CD4) in patients with refractory cutaneous T-cell lymphoma (CTCL) have been assessed in two, Phase II, multicenter, prospective, open-label, uncontrolled clinical studies. Patients with treatment refractory CD4+ CTCL (mycosis fungoides [MF], n=38; Sezary syndrome [SS], n=9) received 17 weekly infusions of zanolimumab (early-stage patients, 280/560 mg; advanced-stage patients, 280/980 mg). The primary endpoint was objective response (OR), as assessed by Composite Assessment (CA) of Index Lesion Disease Activity Score. Secondary endpoints 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.
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