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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CLINICAL TRIALS AND OBSERVATIONS
Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma
Youn H. Kim1,
Madeleine Duvic2,
Erik Obitz3,
Robert Gniadecki4,
Lars Iversen3,
Anders Österborg5,
Sean Whittaker6,
Timothy M. Illidge7,
Thomas Schwarz8,
Roland Kaufmann9,
Kevin Cooper10,
Kim M. Knudsen11,
Steen Lisby11,
Ole Baadsgaard11, and
Susan J. Knox12
1 Multidisciplinary Cutaneous Lymphoma Program, Stanford Comprehensive Cancer Center, CA;
2 M.D. Anderson Cancer Center, Houston, TX;
3 Aarhus University Hospital, Denmark;
4 Bispebjerg Hospital, Copenhagen, Denmark;
5 Karolinska Hospital, Stockholm, Sweden;
6 St Thomas' Hospital, London, United Kingdom;
7 Manchester University, Christie Hospital, United Kingdom;
8 Department of Dermatology, University Kiel, Germany;
9 Universitätshautklinik, Frankfurt aM, Germany;
10 Case Western Reserve University Hospital of Cleveland, OH;
11 Genmab, Copenhagen, Denmark;
12 Department of Radiation Oncology, Stanford Comprehensive Cancer Center, CA
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.
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